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Statutory Instruments

2017 No. 1206

Telecommunications

The Radio Equipment Regulations 2017

Made

4th December 2017

Laid before Parliament

5th December 2017

Coming into force

26th December 2017

M1M2The Secretary of State is a Minister designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to measures relating to radio equipment.

These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 and it appears to the Secretary of State that it is expedient for certain references to provisions of EU instruments to be construed as references to those provisions as amended from time to time.

The Secretary of State makes these Regulations in exercise of the powers conferred by section 2(2) of, and paragraph 1A M3 of Schedule 2 to, the European Communities Act 1972.

Modifications etc. (not altering text)

Marginal Citations

M1S.I. 1999/2788 to which there are amendments not relevant to these Regulations.

M21972 c.68; section 2(2) was amended by section 27(1) of the Legislative and Regulatory Reform Act 2006 (c.51) and by Part 1 of the Schedule to the European Union (Amendment) Act 2008 (c.7). The enabling powers of section 2(2) were extended by virtue of the amendment of section 1(2) by section 1 of the European Economic Area Act 1993 (c.51).

M3Paragraph 1A of Schedule 2 was inserted by section 28 of the Legislative and Regulatory Reform Act 2006 and amended by Part 1 of the Schedule to the European Union (Amendment) Act 2008.

PART 1U.K.Preliminary

Citation and commencementU.K.

1.  These Regulations may be cited as the Radio Equipment Regulations 2017 and come into force on 26th December 2017.

Interpretation and applicationE+W+S

2.—(1) In these Regulations—

“the 1987 Act” means the Consumer Protection Act 1987 M4;

[F1“approved body” has the meaning given to it in regulation 46 (approved bodies);]

F2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

“authorised representative” means a person appointed in accordance with regulation 19;

F4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F6“commencement date” means the date these regulations come into force;]

“conformity assessment” means the process demonstrating whether the essential requirements relating to radio equipment have been fulfilled;

“conformity assessment body” means a body that performs conformity assessment activities;

[F7“declaration of conformity” means a declaration of conformity required to be drawn up in accordance with regulation 42 by regulation 10(1)(a) ( declaration of conformity);]

[F7“designated standard” has the meaning given to it in regulation 2A;]

“distributor” means any person in the supply chain, other than the manufacturer, authorised representative or the importer, who makes radio equipment available on the market;

[F8“the Directive” means Directive 2014/53/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment;]

“economic operator” means a manufacturer, authorised representative, importer or distributor;

[F9“electromagnetic disturbance” means any electromagnetic phenomenon which may degrade the performance of equipment; an electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the propagation medium itself;]

“enforcing authority” means any person enforcing these Regulations under regulation 56 (enforcement);

“essential requirements” means the requirements set out in regulation 6;

F10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F11. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F12“harmful interference” means interference which endangers the functioning of a radio navigation service or of other safety services or which otherwise seriously degrades, obstructs or repeatedly interrupts a radiocommunications service operating in accordance with the applicable international, European Community or national regulations;]

F13. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F14“the Implementing Regulation” means Commission Implementing Regulation (EU) 2017/1354 specifying how to present the information provided for in Article 10(10) of Directive 2014/53/EU of the European Parliament and of the Council;]

[F15“importer” means a person who—

(a)

is established in the United Kingdom and places radio equipment from a country outside of the United Kingdom on the market; or

(b)

is established in Northern Ireland and places radio equipment on the market that has been supplied to them for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge, from an EEA state;]

“make available on the market” means any supply for distribution, consumption or use of radio equipment on the [F16market of Great Britain] in the course of a commercial activity, whether in return for payment or free of charge, and related expressions must be construed accordingly;

“manufacturer” means a person who—

(a)

manufactures radio equipment or has radio equipment designed or manufactured; and

(b)

markets that radio equipment under that person's name or trade mark;

“market surveillance authority” has the meaning set out in regulation 55 (designation of market surveillance authorities”);

F17. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

“OFCOM” means the Office of Communications established under the Office of Communications Act 2002 M5;

F19. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

“place on the market” means the first making available on the [F20market of Great Britain] of radio equipment, and related expressions must be construed accordingly;

“put into service” means the first use of radio equipment in [F21Great Britain] by its end-user for the purposes for which it was intended, and related expressions must be construed accordingly;

“radiodetermination” means the determination of the position, velocity and/or other characteristics of an object, or the obtaining of information relating to those parameters, by means of the propagation properties of radio waves;

“radio communication” means communication by means of radio waves;

“radio equipment” means—

(a)

an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, or

(b)

an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination;

“radio waves” means electromagnetic waves of frequencies lower than 3,000 GHz, propagated in space without artificial guide;

“RAMS” means Regulation (EC) No 765/2008M6 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products;

“recall” means taking any measure aimed at achieving the return of radio equipment that has already been made available to the end-user and related expressions must be construed accordingly;

“relevant conformity assessment procedure” means a conformity assessment procedure referred to in regulation 41 (conformity assessment procedures);

“relevant economic operator” means, in relation to radio equipment, an economic operator with obligations in respect of that radio equipment under Part 2;

“technical documentation” has the meaning set out in regulation 45 (technical documentation);

“technical specification” means a document that prescribes technical requirements to be fulfilled by radio equipment;

[F22“UK marking” means the marking in the form set out in Annex 2 of RAMS;]

[F22“UK national accreditation body” means the body appointed by the Secretary of State in accordance with Article 4 of RAMS;]

“weights and measures authority” means a local weights and measures authority within the meaning set out in section 69 of the Weights and Measures Act 1985 M7;

“withdraw” means taking any measure aimed at preventing radio equipment in the supply chain from being made available on the market and related expressions must be construed accordingly.

(2) In these Regulations, a reference to radio equipment being “in conformity with Part 2” means that—

(a)the radio equipment is in conformity with the essential requirements, and

(b)each relevant economic operator has complied with the obligations imposed on them under Part 2 which must be satisfied at or before the time at which they make the radio equipment available on the market.

F23(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) In regulations 18 and 26 (monitoring in relation to manufacturers and importers respectively) “risk” means a risk which could arise from lawful and readily predictable human behaviour.

(5) In the other provisions of these Regulations, “risk” means a risk—

(a)which could arise from lawful and readily predictable human behaviour, or

(b)of non-conformity with the essential requirements.

F24(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Marginal Citations

M6OJ L 218, 13.8.2008, p.30.

Interpretation and applicationN.I.

2.—(1) In these Regulations—

“the 1987 Act” means the Consumer Protection Act 1987 F277;

“accreditation” has the meaning set out in point 10 of Article 2 of RAMS (as amended from time to time);

“accreditation certificate” means a certificate, issued by either the United Kingdom Accreditation Service (a company limited by guarantee incorporated in England and Wales under number 03076190) or by a national accreditation body in another [F278relevant state], attesting that a conformity assessment body meets the notified body requirements;

“authorised representative” means a person appointed in accordance with regulation 19;

“CE marking” means a marking which takes the form set out in Annex II of RAMS (as amended from time to time);

“competent national authority” means an authority having responsibility for enforcing the law of a [F279relevant state] which implements the Directive;

“conformity assessment” means the process demonstrating whether the essential requirements relating to radio equipment have been fulfilled;

“conformity assessment body” means a body that performs conformity assessment activities;

“distributor” means any person in the supply chain, other than the manufacturer, authorised representative or the importer, who makes radio equipment available on the market;

“the Directive” means Directive 2014/53/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment F280;

“economic operator” means a manufacturer, authorised representative, importer or distributor;

“electromagnetic disturbance” has the meaning set out in point (5) of paragraph 1 of Article 3 of Directive 2014/30/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to electromagnetic compatibility F281;

“enforcing authority” means any person enforcing these Regulations under regulation 56 (enforcement);

“essential requirements” means the requirements set out in regulation 6;

“EU declaration of conformity” means a declaration of conformity required to be drawn up in accordance with regulation 42 by regulation 10(1)(a) (EU declaration of conformity);

“European Commission” means the Commission of the European Union;

“harmful interference” has the meaning set out in point (r) of Article 2 of Directive 2002/21/EC of the European Parliament and of the Council on a common regulatory framework for electronic communications networks and services F282 (as amended from time to time);

“harmonised standard” has the meaning set out in Article 2(1)(c) of Regulation (EU) No 1025/2012 of the European Parliament and of the Council on European standardisation F283 (as amended from time to time);

“importer” means any person who—

(a)

is established within the [F284relevant market]; and

(b)

places radio equipment from a [F285market outside of the relevant market on the relevant] market;

“make available on the market” means any supply for distribution, consumption or use of radio equipment on the [F286relevant] market in the course of a commercial activity, whether in return for payment or free of charge, and related expressions must be construed accordingly;

“manufacturer” means a person who—

(a)

manufactures radio equipment or has radio equipment designed or manufactured; and

(b)

markets that radio equipment under that person's name or trade mark;

“market surveillance authority” has the meaning set out in regulation 55 (designation of market surveillance authorities”);

“national accreditation body” has the meaning set out in point 11 of Article 2 of RAMS (as amended from time to time);

[F287“NI Protocol obligation” means any obligation created or arising by or under the Protocol on Ireland/ Northern Ireland in the EU withdrawal agreement, whether or not an obligation to which section 7A(2) of the European Union (Withdrawal) Act 2018 applies;]

“notified body requirements” means the requirements set out in Schedule 8 (notified body requirements);

“OFCOM” means the Office of Communications established under the Office of Communications Act 2002 F288;

“Official Journal” means the Official Journal of the European Union;

“place on the market” means the first making available on the [F289relevant] market of radio equipment, and related expressions must be construed accordingly;

“put into service” means the first use of radio equipment in the [F290relevant market] by its end-user for the purposes for which it was intended, and related expressions must be construed accordingly;

“radiodetermination” means the determination of the position, velocity and/or other characteristics of an object, or the obtaining of information relating to those parameters, by means of the propagation properties of radio waves;

“radio communication” means communication by means of radio waves;

“radio equipment” means—

(a)

an electrical or electronic product, which intentionally emits and/or receives radio waves for the purpose of radio communication and/or radiodetermination, or

(b)

an electrical or electronic product which must be completed with an accessory, such as antenna, so as to intentionally emit and/or receive radio waves for the purpose of radio communication and/or radiodetermination;

“radio waves” means electromagnetic waves of frequencies lower than 3,000 GHz, propagated in space without artificial guide;

“RAMS” means Regulation (EC) No 765/2008 F291 of the European Parliament and of the Council setting out the requirements for accreditation and market surveillance relating to the marketing of products;

“recall” means taking any measure aimed at achieving the return of radio equipment that has already been made available to the end-user and related expressions must be construed accordingly;

“relevant conformity assessment procedure” means a conformity assessment procedure referred to in regulation 41 (conformity assessment procedures);

“relevant economic operator” means, in relation to radio equipment, an economic operator with obligations in respect of that radio equipment under Part 2;

[F292“relevant market” means—

(a)

the market in Northern Ireland; and

(b)

the market of the EEA states;]

[F292“relevant state” means—

(a)

Northern Ireland; or

(b)

any EEA state;]

“technical documentation” has the meaning set out in regulation 45 (technical documentation);

“technical specification” means a document that prescribes technical requirements to be fulfilled by radio equipment;

[F293“UK(NI) indication” means the marking in the form set out in Schedule 1 to the Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020;]

“weights and measures authority” means a local weights and measures authority within the meaning set out in section 69 of the Weights and Measures Act 1985 F294;

“withdraw” means taking any measure aimed at preventing radio equipment in the supply chain from being made available on the market and related expressions must be construed accordingly.

(2) In these Regulations, a reference to radio equipment being “in conformity with Part 2” means that—

(a)the radio equipment is in conformity with the essential requirements, and

(b)each relevant economic operator has complied with the obligations imposed on them under Part 2 which must be satisfied at or before the time at which they make the radio equipment available on the market.

(3) In these Regulations (except in Part 4 (notification of conformity assessment bodies) and Schedules 8 (notified body requirements) and 9 (operational obligations of notified bodies)), “notified body” means—

(a)a notified body within the meaning set out in regulation 46 (notified bodies), or

(b)a notified body under the laws of any other [F295relevant state] which implements the Directive.

(4) In regulations 18 and 26 (monitoring in relation to manufacturers and importers respectively) “risk” means a risk which could arise from lawful and readily predictable human behaviour.

(5) In the other provisions of these Regulations, “risk” means a risk—

(a)which could arise from lawful and readily predictable human behaviour, or

(b)of non-conformity with the essential requirements.

F296(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E91This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F280OJ L 153, 22.5.2014, p.62.

F281OJ L 96, 29.3.2014, p.79.

F282OJ L 108, 24.04.2002, p.33.

F283OJ L 316, 14.11.2012, p.12.

F291OJ L 218, 13.8.2008, p.30.

F293Words in reg. 2(1) inserted (N.I.) (31.12.2020) by The Product Safety and Metrology etc. (Amendment etc.) (UK(NI) Indication) (EU Exit) Regulations 2020 (S.I. 2020/1460), reg. 1(2), Sch. 2 para. 14(2)

[F25Designated standardE+W+S

2A.—(1) Subject to paragraphs (6) and (7), in these Regulations a reference to a “designated standard” means a technical specification which is—

(a)adopted by a recognised standardisation body [F26or an international standardising body], for repeated or continuous application, with which compliance is not compulsory; and

(b)designated by the Secretary of State by publishing the reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.

(2) For the purposes of paragraph (1), a “technical specification” means a document that prescribes technical requirements to be fulfilled by a product, process, service or system and which lays down one or more of the following—

(a)the characteristics required of a product, including—

(i)levels of quality, performance, interoperability, environmental protection, health, safety or dimensions, and

(ii)the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures;

(b)production methods and processes relating to the product, where these have an effect on the characteristics of the product.

(3) For the purposes of this regulation a “recognised standardisation body” means any one of the following organisations—

(a)the European Committee for Standardisation (CEN);

(b)the European Committee for Electrotechnical Standardisation (Cenelec);

(c)the European Telecommunications Standards Institute (ETSI);

(d)the British Standards Institution (BSI).

[F27(3A) In this regulation “international standardising body” has the same meaning as it has for the purposes of the Agreement on Technical Barriers to Trade, part of Annex 1A to the agreement establishing the World Trade Organisation signed at Marrakesh on 15 April 1994 (as modified from time to time).]

(4) When considering whether the publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

(5) Before publishing the reference to a technical specification adopted by the British Standards Institution, the Secretary of State must have regard to whether the technical specification is consistent with [F28such] technical specifications adopted by the other recognised standardisation bodies [F29or by international standardising bodies as the Secretary of State considers to be relevant].

(6) The Secretary of State may remove the reference to a standard from publication referred to in paragraph (1)(b).

(7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

(8) In this regulation, a reference to a “product” is a reference to radio equipment to which these Regulations apply.

(9) The Secretary of State may by regulations amend paragraph (3) to reflect any changes in the name or structure of the recognised standardisation bodies referred.

(10) Regulations made under paragraph (9) are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.]

Textual Amendments

ScopeE+W+S

3.—(1) These Regulations apply to radio equipment.

(2) These Regulations do not apply to—

(a)radio equipment which has been placed on the market before the commencement date,

(b)equipment listed in Schedule 1 (radio equipment outside the scope of these Regulations), or

(c)radio equipment exclusively used for activities concerning public security, defence, State security (including the economic well-being of the State) or the activities of the State in the area of criminal law.

(3) Save as provided for in regulation 6(1)(a), radio equipment falling within the scope of these Regulations are not subject to F30... the Electrical Equipment (Safety) Regulations 2016 M8.

(4) Save as provided for in regulation 6(1)(b), radio equipment falling within the scope of these Regulations are not subject to F31... the Electromagnetic Compatibility Regulations 2016 M9.

Extent Information

E2This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Marginal Citations

ScopeN.I.

3.—(1) These Regulations apply to radio equipment.

(2) These Regulations do not apply to—

(a)radio equipment which has been placed on the market before the commencement date,

(b)equipment listed in Schedule 1 (radio equipment outside the scope of these Regulations), or

(c)radio equipment exclusively used for activities concerning public security, defence, State security (including the economic well-being of the State) or the activities of the State in the area of criminal law.

(3) Save as provided for in regulation 6(1)(a), radio equipment falling within the scope of these Regulations are not subject to Directive 2014/35/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits F297 or the Electrical Equipment (Safety) Regulations 2016 F298.

(4) Save as provided for in regulation 6(1)(b), radio equipment falling within the scope of these Regulations are not subject to Directive 2014/30/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to electromagnetic compatibility or the Electromagnetic Compatibility Regulations 2016 F299.

Extent Information

E92This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F297OJ L 96, 29.3.2014, p.357.

Exception for trade fairs and exhibitionsU.K.

4.—(1) Nothing in these Regulations prevents the display, of radio equipment which does not comply with these Regulations, at a trade fair, exhibition or similar event provided that a visible sign clearly indicates that the radio equipment—

(a)is not in conformity with Part 2, and

(b)may not be made available on the market or put into service until it has been brought into conformity with Part 2.

(2) Nothing in these Regulations prevents the demonstration, of radio equipment which does not comply with these Regulations, at a trade fair, exhibition or similar event provided that all reasonable measures have been taken to avoid harmful interference, electromagnetic disturbances and risk to health and safety of persons, domestic animals or property.

Putting into service and useE+W+S

5.—(1) Nothing in these Regulations prevents the putting into service and use of radio equipment in the United Kingdom which is in conformity with these Regulations when the radio equipment is properly installed, maintained and used for its intended purpose.

(2) Nothing in these Regulations prevents the application of additional requirements for the putting into service or use of radio equipment in the United Kingdom for reasons related to—

(a)the effective and efficient use of the radio spectrum,

(b)the avoidance of harmful interference,

(c)the avoidance of electromagnetic disturbances, or

(d)public health.

Extent Information

E3This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Putting into service and useN.I.

5.—(1) Nothing in these Regulations prevents the putting into service and use of radio equipment in [F300Northern Ireland] which is in conformity with these Regulations when the radio equipment is properly installed, maintained and used for its intended purpose.

(2) Nothing in these Regulations prevents the application of additional requirements for the putting into service or use of radio equipment in [F300Northern Ireland] for reasons related to—

(a)the effective and efficient use of the radio spectrum,

(b)the avoidance of harmful interference,

(c)the avoidance of electromagnetic disturbances, or

(d)public health.

Extent Information

E93This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

PART 2 U.K.Obligations of economic operators

CHAPTER 1U.K.General

Essential requirementsE+W+S

6.—(1) Radio equipment must be constructed so as to ensure—

(a)the protection of health and safety of persons and of domestic animals and the protection of property, including the objectives with respect to safety requirements set out in [F32the Electrical Equipment (Safety) Regulations 2016] F33...,

(b)an adequate level of electromagnetic compatibility as set out in [F34the Electromagnetic Compatibility Regulations 2016] F35....

(2) Radio equipment must be constructed so that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference.

Extent Information

E4This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Essential requirementsN.I.

6.—(1) Radio equipment must be constructed so as to ensure—

(a)the protection of health and safety of persons and of domestic animals and the protection of property, including the objectives with respect to safety requirements set out in Directive 2014/35/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to the making available on the market of electrical equipment designed for use within certain voltage limits (but as if there were no voltage limit),

(b)an adequate level of electromagnetic compatibility as set out in Directive 2014/30/EU of the European Parliament and of the Council on the harmonisation of the laws of the Member States relating to electromagnetic compatibility.

(2) Radio equipment must be constructed so that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference.

[F301(3) Where paragraph (4) applies, radio equipment must be constructed so that it complies with the requirements of Article 1 of Commission Delegated Regulation (EU) 2019/320 supplementing Directive 2014/53/EU of the European Parliament and of the Council with regard to the application of the essential requirements referred to in Article 3(3)(g) of that Directive in order to ensure caller location in emergency communications from mobile devices.

(4) This paragraph applies to radio equipment in the form of hand-held mobile telephones with features similar to those of a computer in terms of capability to treat and store data.]

Extent Information

E94This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

[F36Power to specify additional essential requirementsE+W+S

6A.—(1) The Secretary of State may by regulations—

(a)amend regulation 6 to add any of the matters listed in paragraph (2) as additional essential requirements; and

(b)specify that only certain categories or classes of radio equipment are required to meet any additional essential requirements.

(2) The matters that may be added as additional essential requirements are that the—

(a)radio equipment interworks with accessories, in particular with common chargers;

(b)radio equipment interworks via networks with other radio equipment;

(c)radio equipment can be connected to interfaces of the appropriate type throughout the United Kingdom;

(d)radio equipment does not harm the network or its functioning nor misuse network resources, thereby causing an unacceptable degradation of service;

(e)radio equipment incorporates safeguards to ensure that the personal data and privacy of the user and of the subscriber are protected;

(f)radio equipment supports certain features ensuring protection from fraud;

(g)radio equipment supports certain features ensuring access to emergency services;

(h)radio equipment supports certain features in order to facilitate its use by users with a disability;

(i)radio equipment supports certain features in order to ensure that software can only be loaded into the radio equipment where the compliance of the combination of the radio equipment and software has been demonstrated.

(3) Regulations made under paragraph (1)—

(a)may make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate; and

(b)are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.]

Textual Amendments

CHAPTER 2U.K.Manufacturers

Design and manufacture in accordance with essential requirementsU.K.

7.  Before placing radio equipment on the market, a manufacturer must ensure that it has been designed and manufactured in accordance with the essential requirements.

Construction must allow operation [F37without infringement of requirements] E+W+S

8.  Before placing radio equipment on the market, a manufacturer must ensure it has been constructed so that the radio equipment can be operated F38... without causing an infringement of the applicable requirements on the use of the radio spectrum F38....

Extent Information

E5This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Construction must allow operation in at least one [F302relevant] StateN.I.

8.  Before placing radio equipment on the market, a manufacturer must ensure it has been constructed so that the radio equipment can be operated in at least one [F303relevant state] without causing an infringement of the applicable requirements on the use of the radio spectrum in the relevant [F303relevant state] or [F304relevant states].

Extent Information

E95This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Technical documentation and conformity assessmentU.K.

9.  Before placing radio equipment on the market, a manufacturer must—

(a)draw up the relevant technical documentation in accordance with regulation 45 (technical documentation), and

(b)ensure the relevant conformity assessment procedure is carried out.

[F39Declaration] of conformity and [F40UK] markingE+W+S

10.—(1) Where the compliance of radio equipment with the essential requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the radio equipment on the market—

(a)draw up [F41a] declaration of conformity in accordance with regulation 42 [F42(declaration of conformity)], and

(b)affix the [F43UK] marking in accordance with regulation 44 [F44(UK marking)].

(2) The manufacturer must keep the F45... declaration of conformity up to date.

[F46(3) Where radio equipment is subject to more than one enactment requiring the drawing up of a declaration of conformity, the manufacturer must draw up a single declaration of conformity which identifies each enactment by its title.]

Extent Information

E6This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

EU declaration of conformity and CE markingN.I.

10.—(1) Where the compliance of radio equipment with the essential requirements has been demonstrated by a relevant conformity assessment procedure, the manufacturer must, before placing the radio equipment on the market—

(a)draw up an EU declaration of conformity in accordance with regulation 42 (EU declaration of conformity), and

(b)affix the CE marking in accordance with regulation 44 (CE marking).

(2) The manufacturer must keep the EU declaration of conformity up to date.

(3) Where radio equipment is subject to more than one [F305NI Protocol obligation] requiring an EU declaration of conformity to be drawn up, the manufacturer must draw up a single EU declaration of conformity which—

(a)meets the requirements of all of the EU instruments concerned,

(b)identifies the EU instruments, and

(c)includes references to the publication of those EU instruments in the Official Journal.

Extent Information

E96This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Retention of technical documentation and F47... declaration of conformityE+W+S

11.  A manufacturer must, for a period of 10 years beginning on the day on which the radio equipment is placed on the market, keep and, upon request, make available to an enforcing authority the following in relation to radio equipment—

(a)a copy of the F48... declaration of conformity, and

(b)the technical documentation.

Extent Information

E7This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Retention of technical documentation and EU declaration of conformityN.I.

11.  A manufacturer must, for a period of 10 years beginning on the day on which the radio equipment is placed on the market, keep and, upon request, make available to an enforcing authority the following in relation to radio equipment—

(a)a copy of the EU declaration of conformity, and

(b)the technical documentation.

Extent Information

E97This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Identification of the radio equipment and manufacturerE+W+S

12.—(1) Before placing radio equipment on the market, a manufacturer must ensure that the radio equipment bears—

(a)a type, batch or serial number, or

(b)another element which allows the radio equipment to be identified.

(2) Before placing radio equipment on the market, a manufacturer must indicate on the radio equipment—

(a)the name, registered trade name or registered trade mark of the manufacturer,

(b)a postal address at which the manufacturer can be contacted.

(3) The information specified in paragraph (2) must be in a language which can be easily understood by end-users and the [F49enforcing authority].

(4) Where the size or nature of the radio equipment prohibits a manufacturer from complying with the requirement in paragraph (1) or paragraph (2), the manufacturer must provide the required information either on the radio equipment's packaging or in a document which accompanies the radio equipment.

(5) The manufacturer's postal address must indicate a single point at which the manufacturer can be contacted.

Extent Information

E8This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Identification of the radio equipment and manufacturerN.I.

12.—(1) Before placing radio equipment on the market, a manufacturer must ensure that the radio equipment bears—

(a)a type, batch or serial number, or

(b)another element which allows the radio equipment to be identified.

(2) Before placing radio equipment on the market, a manufacturer must indicate on the radio equipment—

(a)the name, registered trade name or registered trade mark of the manufacturer,

(b)a postal address at which the manufacturer can be contacted.

(3) The information specified in paragraph (2) must be in a language which can be easily understood by end-users and the competent national authority in the [F306relevant state] in which it is to be made available to such end-users.

(4) Where the size or nature of the radio equipment prohibits a manufacturer from complying with the requirement in paragraph (1) or paragraph (2), the manufacturer must provide the required information either on the radio equipment's packaging or in a document which accompanies the radio equipment.

(5) The manufacturer's postal address must indicate a single point at which the manufacturer can be contacted.

Extent Information

E98This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Instructions and information to be included with the radio equipmentE+W+S

13.—(1) When placing radio equipment on the market, a manufacturer must ensure that radio equipment is accompanied with instructions and safety information which—

[F50(a)are clear, legible and in easily understandable English,]

(b)include information required to use the radio equipment in accordance with its intended use, [F51and]

(c)include a description of accessories and components, including software, which allow the radio equipment to operate as intended [F52.]

F53(d). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(2) In the case of radio equipment which can intentionally emit radio waves, the manufacturer must also include information about—

(a)the frequency band or bands in which the radio equipment can operate, and

(b)the maximum radio-frequency power transmitted in the frequency band or bands in which the radio equipment operates.

(3) When placing radio equipment on the market, a manufacturer must ensure that each item of radio equipment is accompanied by either a copy of the F54... declaration of conformity or a simplified F54... declaration of conformity drawn up in accordance with regulation 43 (simplified F54... declaration of conformity).

F55(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E9This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Instructions and information to be included with the radio equipmentN.I.

13.—(1) When placing radio equipment on the market, a manufacturer must ensure that radio equipment is accompanied with instructions and safety information which—

(a)are in a language which can be easily understood by consumers and other end-users in the [F307relevant state] in which the radio equipment is to be made available to such consumers and other end-users,

(b)include information required to use the radio equipment in accordance with its intended use,

(c)include a description of accessories and components, including software, which allow the radio equipment to operate as intended, and

(d)are clear and understandable.

(2) In the case of radio equipment which can intentionally emit radio waves, the manufacturer must also include information about—

(a)the frequency band or bands in which the radio equipment can operate, and

(b)the maximum radio-frequency power transmitted in the frequency band or bands in which the radio equipment operates.

(3) When placing radio equipment on the market, a manufacturer must ensure that each item of radio equipment is accompanied by either a copy of the EU declaration of conformity or a simplified EU declaration of conformity drawn up in accordance with regulation 43 (simplified EU declaration of conformity).

(4) Where the radio equipment is to be made available to consumers and other end-users in [F308Northern Ireland], the language which can be easily understood is English.

Extent Information

E99This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Information to be included where there are restrictions on putting into service or requirements for authorisation of useE+W+S

14.—[F56(1) Where there are restrictions on putting into service or requirements for authorisation of use in the United Kingdom in respect of the radio equipment, a manufacturer must present information which identifies the types of restrictions on putting into service or requirements for authorisation of use that apply.]

(2) The information referred to in paragraph (1) must—

(a)be completed in the instructions required by regulation 13,

(b)F57... be presented in the manner and form specified in [F58the] Implementing Regulation F59....

F60(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E10This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Information to be included where there are restrictions on putting into service or requirements for authorisation of useN.I.

14.—(1) Where there are restrictions on putting into service or requirements for authorisation of use, a manufacturer must include information on the packaging of the radio equipment which identifies the [F309relevant states] and the geographical area within a [F310relevant state] where the restrictions on putting into service or the requirements for authorisation of use exist.

(2) The information referred to in paragraph (1) must—

(a)be completed in the instructions required by regulation 13,

(b)subject to paragraph [F311(2A) or] (3), be presented in the manner and form specified in Commission Implementing Regulation specifying how to present the information provided for in Article 10(10) of Directive 2104/53/EU of the European Parliament and the Council (EU) 2017/1354 F312.

[F313(2A) The identification of the United Kingdom in respect of Northern Ireland must be indicated by the abbreviation “UK(NI)”.]

(3) Paragraph (2)(b) of this Regulation applies to radio equipment placed on the market or after 8th August 2018.

Extent Information

E100This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F312OJ L190/7 21.7.2017.

Duty to take action in respect of radio equipment placed on the market which is considered not to be in conformityE+W+S

15.—(1) A manufacturer who considers, or has reason to believe, that radio equipment which they have placed on the market is not in conformity with Part 2, if appropriate, must immediately take the corrective measures necessary to—

(a)bring the radio equipment into conformity,

(b)withdraw the radio equipment, or

(c)recall the radio equipment.

(2) Where the radio equipment presents a risk, the manufacturer must immediately inform the market surveillance authority F61... of the risk, giving details of—

(a)the respect in which the radio equipment is considered not to be in conformity with Part 2, and

(b)any corrective measures taken and the results of those measures.

Extent Information

E11This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Duty to take action in respect of radio equipment placed on the market which is considered not to be in conformityN.I.

15.—(1) A manufacturer who considers, or has reason to believe, that radio equipment which they have placed on the market is not in conformity with Part 2, if appropriate, must immediately take the corrective measures necessary to—

(a)bring the radio equipment into conformity,

(b)withdraw the radio equipment, or

(c)recall the radio equipment.

(2) Where the radio equipment presents a risk, the manufacturer must immediately inform the market surveillance authority, and the competent national authorities of any other [F314relevant state] in which the manufacturer made the radio equipment available on the market, of the risk, giving details of—

(a)the respect in which the radio equipment is considered not to be in conformity with Part 2, and

(b)any corrective measures taken and the results of those measures.

Extent Information

E101This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Provision of information and cooperationE+W+S

16.—[F62(1) Following a request from the enforcing authority, the manufacturer must, within such reasonable period as the authority may specify, provide the authority concerned with all the information and documentation necessary to demonstrate that the radio equipment is in conformity with Part 2.]

(2) A request referred to in paragraph (1)—

(a)is one that was made during the period of 10 years beginning on the day that the manufacturer places the radio equipment on the market, and

(b)must be accompanied by the reasons for making the request.

(3) The information referred to in paragraph (1)—

(a)may be provided in electronic form, and

(b)must be in a language which can be easily understood by the authority concerned.

(4) A manufacturer must, at the request of the authority concerned, cooperate with that authority on any action taken to—

(a)evaluate radio equipment in accordance with regulation 59 (evaluation of radio equipment presenting a risk),

(b)eliminate the risks posed by radio equipment which the manufacturer has placed on the market.

Extent Information

E12This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Provision of information and cooperationN.I.

16.—(1) Further to a request from—

(a)an enforcing authority, where radio equipment has been placed by a manufacturer on the market in the United Kingdom, or

(b)a competent national authority, where the radio equipment has been placed by a manufacturer on the market in another [F315relevant state],

the manufacturer must, within such reasonable period as the authority may specify, provide the authority concerned with all the information and documentation necessary to demonstrate that the radio equipment is in conformity with Part 2.

(2) A request referred to in paragraph (1)—

(a)is one that was made during the period of 10 years beginning on the day that the manufacturer places the radio equipment on the market, and

(b)must be accompanied by the reasons for making the request.

(3) The information referred to in paragraph (1)—

(a)may be provided in electronic form, and

(b)must be in a language which can be easily understood by the authority concerned.

(4) A manufacturer must, at the request of the authority concerned, cooperate with that authority on any action taken to—

(a)evaluate radio equipment in accordance with regulation 59 (evaluation of radio equipment presenting a risk),

(b)eliminate the risks posed by radio equipment which the manufacturer has placed on the market.

Extent Information

E102This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Compliance procedures for series productionE+W+S

17.—(1) A manufacturer must ensure, before placing radio equipment on the market, that procedures are in place to ensure that series production remains in conformity with Part 2.

(2) In doing so, the manufacturer must take adequate account of—

(a)any change in radio equipment design or characteristics, and

(b)any change in a [F63designated] standard or in another technical specification by reference to which the F64... declaration of conformity was drawn up.

Extent Information

E13This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Compliance procedures for series productionN.I.

17.—(1) A manufacturer must ensure, before placing radio equipment on the market, that procedures are in place to ensure that series production remains in conformity with Part 2.

(2) In doing so, the manufacturer must take adequate account of—

(a)any change in radio equipment design or characteristics, and

(b)any change in a harmonised standard or in another technical specification by reference to which the EU declaration of conformity was drawn up.

Extent Information

E103This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

MonitoringU.K.

18.—(1) When appropriate, with regard to the risks to the health and safety of end-users presented by radio equipment, a manufacturer must—

(a)carry out sample testing of radio equipment manufactured by it which has been made available on the market,

(b)investigate complaints that radio equipment manufactured by it is not in conformity with Part 2,

(c)keep a register of—

(i)complaints that radio equipment is not in conformity with Part 2,

(ii)radio equipment which is not in conformity with Part 2, and

(iii)radio equipment recalls, and

(d)keep distributors informed of any monitoring carried out under this regulation.

(2) A manufacturer must keep an entry made in the register for a period of at least 10 years beginning on the day on which the obligation to make the entry arose.

[F65Provision of information on compliance of combinations of radio equipment and softwareE+W+S

18A.—(1) In this regulation “product” means a combination of radio equipment and software allowing such radio equipment to be used as intended.

(2) The Secretary of State may by regulations make provision requiring a manufacturer of a product to provide the Secretary of State with information on the compliance of the product with the essential requirements.

(3) Regulations under paragraph (2) may—

(a)specify categories or classes of product for which a manufacturer must provide information on compliance;

(b)include requirements as to—

(i)the identification of the radio equipment and software intended to be used in combination;

(ii)the results of conformity assessment carried out in accordance with regulation 41(conformity assessment procedures);

(iii)the form the information must take;

(c)make provision for the information on compliance to be made available to the enforcing authorities; and

(d)make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate.

(4) Regulations made under paragraph (2) are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.]

Textual Amendments

[F65Power to amend R14(2)(b) and specify how information is to be presentedE+W+S

18B.—(1) In this regulation “product” means radio equipment types that fall within categories of radio equipment affected by a low level of compliance with the essential requirements.

(2) The Secretary of State may by regulations make provision requiring a manufacturer, before placing a product on the market, to—

(a)register information on compliance with the essential requirements; and

(b)affix to the product a registration number allocated by the Secretary of State.

(3) Regulations made under paragraph (2) may specify—

(a)the categories or classes of product in respect of which the manufacturer must register information;

(b)that some or, where the Secretary of State considers necessary, all of the technical documentation listed in Schedule 5 must be registered;

(c)that when setting out a registration process the Secretary of State must take the following matters into account—

(i)whether the process includes a central system of registration by manufacturers;

(ii)whether the process ensures appropriate control of access to information of a confidential nature; and

(iii)whether the process allocates a registration number to each registered radio equipment type.

(4) Regulations made under paragraph (2)—

(a)may make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate; and

(b)are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.]

Textual Amendments

[F65Power to require registration of radio equipmentE+W+S

18C.—(1) The Secretary of State may by regulations—

(a)amend regulation 14(2)(b);

(b)amend the Implementing Regulation;

(c)make provision specifying the manner and form in which information concerning any restrictions or putting into service or requirements for authorisation of use must be presented.

(2) Regulations made under paragraph (1)—

(a)may make such supplemental, consequential and transitional provisions as the Secretary of State considers appropriate; and

(b)are to be made by statutory instrument subject to annulment in pursuance of a resolution of either House of Parliament.]

Textual Amendments

Authorised representativesE+W+S

19.—(1) A manufacturer may, by written mandate, appoint a person established [F66in the United Kingdom] as their authorised representative to perform specified tasks on that manufacturer's behalf.

(2) The authorised representative must perform the tasks specified in the mandate.

(3) The mandate must allow the authorised representative to do at least the following—

(a)perform the manufacturer's obligations under regulation 11 (retention of technical documentation and F67... declaration of conformity),

(b)perform the manufacturer's obligations under regulation 16 (provision of information and cooperation).

(4) The mandate must not include the obligations contained in—

(a)regulation 7 (design and manufacture in accordance with essential requirements),

(b)regulation 9 (technical documentation and conformity assessment), or

(c)regulation 10 (F68... declaration of conformity and [F69UK] marking).

(5) An authorised representative must comply with all the obligations imposed on the manufacturer by these Regulations which relate to the tasks that the authorised representative is appointed by the manufacturer to perform and, accordingly—

(a)as far as those obligations are concerned, references in these Regulations to the manufacturer are to be taken as including a reference to the authorised representative, and

(b)if the authorised representative contravenes or fails to comply with any of those obligations, the authorised representative may be proceeded against as though the authorised representative was the manufacturer.

(6) A manufacturer who has appointed an authorised representative to perform, on the manufacturer's behalf, an obligation under these Regulations remains responsible for the proper performance of that obligation.

Extent Information

E14This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Authorised representativesN.I.

19.—(1) A manufacturer may, by written mandate, appoint a person established within the [F316relevant market] as their authorised representative to perform specified tasks on that manufacturer's behalf.

(2) The authorised representative must perform the tasks specified in the mandate.

(3) The mandate must allow the authorised representative to do at least the following—

(a)perform the manufacturer's obligations under regulation 11 (retention of technical documentation and EU declaration of conformity),

(b)perform the manufacturer's obligations under regulation 16 (provision of information and cooperation).

(4) The mandate must not include the obligations contained in—

(a)regulation 7 (design and manufacture in accordance with essential requirements),

(b)regulation 9 (technical documentation and conformity assessment), or

F317(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) An authorised representative must comply with all the obligations imposed on the manufacturer by these Regulations which relate to the tasks that the authorised representative is appointed by the manufacturer to perform and, accordingly—

(a)as far as those obligations are concerned, references in these Regulations to the manufacturer are to be taken as including a reference to the authorised representative, and

(b)if the authorised representative contravenes or fails to comply with any of those obligations, the authorised representative may be proceeded against as though the authorised representative was the manufacturer.

(6) A manufacturer who has appointed an authorised representative to perform, on the manufacturer's behalf, an obligation under these Regulations remains responsible for the proper performance of that obligation.

Extent Information

E104This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

CHAPTER 3U.K.Importers

Prohibition on placing on the market radio equipment which is not in conformityU.K.

20.  An importer must not place radio equipment on the market unless it is in conformity with the essential requirements.

Requirements which must be satisfied before an importer places radio equipment on the marketE+W+S

21.  Before placing radio equipment on the market, an importer must ensure that—

(a)a relevant conformity assessment has been carried out by the manufacturer,

(b)that the radio equipment has been constructed so that it can be operated F70... without causing an infringement of the applicable requirements on the use of the radio spectrumF70...,

(c)the manufacturer has drawn up the technical documentation,

(d)the radio equipment—

(i)bears the [F71UK] marking, and

(ii)is accompanied by the information and documents referred to in regulations 13 (instructions and information to be included with the radio equipment) and 14 (information to be included where there are restrictions on putting into service or requirements for authorisation of use),

(e)the manufacturer has complied with the requirements set out in regulation 12 (identification of the radio equipment and manufacturer).

Extent Information

E15This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Requirements which must be satisfied before an importer places radio equipment on the marketN.I.

21.  Before placing radio equipment on the market, an importer must ensure that—

(a)a relevant conformity assessment has been carried out by the manufacturer,

(b)that the radio equipment has been constructed so that it can be operated in at least one [F318relevant state] without causing an infringement of the applicable requirements on the use of the radio spectrum in the relevant [F318relevant state] or [F319relevant states],

(c)the manufacturer has drawn up the technical documentation,

(d)the radio equipment—

(i)bears the CE marking, and

(ii)is accompanied by the information and documents referred to in regulations 13 (instructions and information to be included with the radio equipment) and 14 (information to be included where there are restrictions on putting into service or requirements for authorisation of use),

(e)the manufacturer has complied with the requirements set out in regulation 12 (identification of the radio equipment and manufacturer).

Extent Information

E105This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Prohibition on placing on the market radio equipment considered not to be in conformity with the essential requirementsU.K.

22.—(1) Where an importer considers, or has reason to believe, that radio equipment is not in conformity with the essential requirements, the importer must not place the radio equipment on the market.

(2) Where the radio equipment presents a risk, the importer must inform the manufacturer and the market surveillance authority of that risk.

Information identifying importerE+W+S

23.—(1) Before placing radio equipment on the market, an importer must indicate on the radio equipment—

(a)the name, registered trade name or registered trade mark of the importer, and

(b)a postal address at which the importer can be contacted.

(2) The information specified in paragraph (1) must be in a language which can be easily understood by end-users and the [F72enforcement authority].

[F73(3) Paragraph (1) does not apply where—

(a)either—

(i)it is not possible to set out the information referred to in paragraph (1) on the radio equipment, or

(ii)the importer has imported the radio equipment from an EEA state or Switzerland and places it on the market within the period of [F74seven years] beginning with IP completion day, and

(b)before placing the radio equipment on the market, the importer sets out the information referred to in paragraph (1)-

(i)on the packaging; or

(ii)in a document accompanying the radio equipment.]

Extent Information

E16This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Modifications etc. (not altering text)

Information identifying importerN.I.

23.—(1) Before placing radio equipment on the market, an importer must indicate on the radio equipment—

(a)the name, registered trade name or registered trade mark of the importer, and

(b)a postal address at which the importer can be contacted.

(2) The information specified in paragraph (1) must be in a language which can be easily understood by end-users and the competent national authority in the [F320relevant state] in which it is to be made available to such end-users.

(3) Where it is not possible to indicate the information specified in paragraph (1) on the radio equipment, the importer must indicate that information—

(a)on the packaging, or

(b)in a document accompanying the radio equipment.

Extent Information

E106This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Modifications etc. (not altering text)

Instructions and safety informationE+W+S

24.—(1) When placing radio equipment on the market, an importer must ensure that it is accompanied by instructions and safety information [F75that are clear, legible and in easily understandable English].

F76(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E17This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Instructions and safety informationN.I.

24.—(1) When placing radio equipment on the market, an importer must ensure that it is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users in the [F321relevant state] in which the radio equipment is to be made available to such consumers and other end-users.

(2) Where the radio equipment is being made available to consumers and other end-users in [F322Northern Ireland], the language which can be easily understood by consumers and other end-users is English.

Extent Information

E107This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Storage and transportU.K.

25.  Where an importer has responsibility for radio equipment, the importer must ensure that the conditions under which the radio equipment is stored or transported do not jeopardise the radio equipment's conformity with the essential requirements.

MonitoringU.K.

26.—(1) When appropriate, with regard to the risks to the health and safety of end-users presented by radio equipment, an importer must—

(a)carry out sample testing of radio equipment made available by the importer on the market,

(b)investigate complaints that radio equipment made available on the market by the importer is not in conformity with Part 2,

(c)keep a register of—

(i)complaints that radio equipment is not in conformity with Part 2,

(ii)radio equipment which is not in conformity with Part 2, and

(iii)radio equipment recalls, and

(d)keep distributors informed of any monitoring carried out under this regulation.

(2) An importer must keep an entry made in the register for a period of at least 10 years beginning on the day on which the obligation to make the entry arose.

Duty to take action in respect of radio equipment placed on the market which is considered not to be in conformityE+W+S

27.—(1) An importer who considers, or has reason to believe, that radio equipment which they have placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a)bring the radio equipment into conformity,

(b)withdraw the radio equipment, or

(c)recall the radio equipment.

(2) Where the radio equipment presents a risk, the importer must immediately inform the market surveillance authority F77... of the risk, giving details of—

(a)the respect in which the radio equipment is considered not to be in conformity with Part 2, and

(b)any corrective measures taken.

Extent Information

E18This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Duty to take action in respect of radio equipment placed on the market which is considered not to be in conformityN.I.

27.—(1) An importer who considers, or has reason to believe, that radio equipment which they have placed on the market is not in conformity with Part 2 must immediately take the corrective measures necessary to—

(a)bring the radio equipment into conformity,

(b)withdraw the radio equipment, or

(c)recall the radio equipment.

(2) Where the radio equipment presents a risk, the importer must immediately inform the market surveillance authority, and the competent national authorities of any other [F323relevant state] in which the importer made the radio equipment available on the market, of the risk, giving details of—

(a)the respect in which the radio equipment is considered not to be in conformity with Part 2, and

(b)any corrective measures taken.

Extent Information

E108This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Retention of technical documentation and F78... declaration of conformityE+W+S

28.  An importer must, for a period of 10 years beginning on the day on which the radio equipment is placed on the market, upon request, make available to an enforcing authority the following in relation to radio equipment—

(a)a copy of the F79... declaration of conformity, and

(b)the technical documentation.

Extent Information

E19This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Retention of technical documentation and EU declaration of conformityN.I.

28.  An importer must, for a period of 10 years beginning on the day on which the radio equipment is placed on the market, upon request, make available to an enforcing authority the following in relation to radio equipment—

(a)a copy of the EU declaration of conformity, and

(b)the technical documentation.

Extent Information

E109This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Provision of information and cooperationE+W+S

29.—(1) Further to a reasoned request from an enforcing authority F80..., an importer, within such period as the authority may specify, must provide the authority with all the information and documentation necessary to demonstrate that the radio equipment is in conformity with Part 2.

(2) A request referred to in paragraph (1)—

(a)may only be made during the period of 10 years beginning on the day that the importer places the radio equipment on the market, and

(b)must be accompanied by the reasons for making the request.

(3) The information referred to in paragraph (1)—

(a)may be provided in electronic form, and

(b)must be in a language which can be easily understood by the [F81enforcing authority].

(4) An importer must, at the request of the enforcing authority or the competent national authority, cooperate with the authority on any action taken to—

(a)evaluate radio equipment in accordance with regulation 59 (evaluation of radio equipment presenting a risk),

(b)eliminate the risks posed by radio equipment which the importer has placed on the market.

Extent Information

E20This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Provision of information and cooperationN.I.

29.—(1) Further to a reasoned request from an enforcing authority or a competent national authority of another [F324relevant state], an importer, within such period as the authority may specify, must provide the authority with all the information and documentation necessary to demonstrate that the radio equipment is in conformity with Part 2.

(2) A request referred to in paragraph (1)—

(a)may only be made during the period of 10 years beginning on the day that the importer places the radio equipment on the market, and

(b)must be accompanied by the reasons for making the request.

(3) The information referred to in paragraph (1)—

(a)may be provided in electronic form, and

(b)must be in a language which can be easily understood by the authority concerned.

(4) An importer must, at the request of the enforcing authority or the competent national authority, cooperate with the authority on any action taken to—

(a)evaluate radio equipment in accordance with regulation 59 (evaluation of radio equipment presenting a risk),

(b)eliminate the risks posed by radio equipment which the importer has placed on the market.

Extent Information

E110This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

CHAPTER 4U.K.Distributors

Duty to act with due careU.K.

30.  When making radio equipment available on the market, a distributor must act with due care to ensure that it is in conformity with Part 2.

Requirements which must be satisfied before a distributor makes radio equipment available on the marketE+W+S

31.—(1) Before making radio equipment available on the market, the distributor must verify that—

(a)the radio equipment—

(i)bears the [F82UK] marking,

(ii)is accompanied by the required documents,

(iii)is accompanied by instructions and safety information [F83which are clear, legible and in easily understandable English],

(b)the manufacturer has complied with the requirements set out in—

(i)regulation 8 (construction must allow operation [F84without infringement of requirements]),

(ii)regulation 12 (identification of the radio equipment and manufacturer),

(iii)regulation 13 (instructions and information to be included with the radio equipment),

(iv)regulation 14 (information to be included where there are restrictions on putting into service or requirements for authorisation of use), and

(c)the importer has complied with the requirements set out in regulation 23 (information identifying importer).

F85(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) In paragraph (1)(a)(ii), “required documents” means any documents that are required to be provided pursuant to regulations 12(4), 14 and 23(3).

Extent Information

E21This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Requirements which must be satisfied before a distributor makes radio equipment available on the marketN.I.

31.—(1) Before making radio equipment available on the market, the distributor must verify that—

(a)the radio equipment—

(i)bears the CE marking,

(ii)is accompanied by the required documents,

(iii)is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users in the [F325relevant state] in which the radio equipment is to be made available on the market,

(b)the manufacturer has complied with the requirements set out in—

(i)regulation 8 (construction must allow operation in at least one [F325relevant state]),

(ii)regulation 12 (identification of the radio equipment and manufacturer),

(iii)regulation 13 (instructions and information to be included with the radio equipment),

(iv)regulation 14 (information to be included where there are restrictions on putting into service or requirements for authorisation of use), and

(c)the importer has complied with the requirements set out in regulation 23 (information identifying importer).

(2) Where the radio equipment is to be made available to consumers and other end-users in [F326Northern Ireland], the language which can easily be understood is English.

(3) In paragraph (1)(a)(ii), “required documents” means any documents that are required to be provided pursuant to regulations 12(4), 14 and 23(3).

Extent Information

E111This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Prohibition on making available on the market where radio equipment not considered to be in conformity with the essential requirementsU.K.

32.—(1) Where a distributor considers, or has reason to believe, that radio equipment is not in conformity with the essential requirements, the distributor must not make the radio equipment available on the market.

(2) Where the radio equipment presents a risk, the distributor must inform the following persons of the risk—

(a)the manufacturer or, where appropriate, the importer, and

(b)the market surveillance authority.

Storage and transportU.K.

33.  Where a distributor has responsibility for radio equipment, the distributor must ensure that the conditions under which it is stored or transported do not jeopardise the radio equipment's conformity with the essential requirements.

Duty to take action in respect of radio equipment made available on the market which is not in conformityE+W+S

34.—(1) A distributor who considers, or has reason to believe, that radio equipment which the distributor has made available on the market is not in conformity with Part 2 must make sure that the necessary corrective measures are taken to—

(a)bring that radio equipment into conformity,

(b)withdraw the radio equipment, or

(c)recall the radio equipment.

(2) Where the radio equipment presents a risk, the distributor must immediately inform the market surveillance authority F86... of that risk, giving details of—

(a)the respect in which the radio equipment is considered not to be in conformity with Part 2, and

(b)any corrective measures taken.

Extent Information

E22This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Duty to take action in respect of radio equipment made available on the market which is not in conformityN.I.

34.—(1) A distributor who considers, or has reason to believe, that radio equipment which the distributor has made available on the market is not in conformity with Part 2 must make sure that the necessary corrective measures are taken to—

(a)bring that radio equipment into conformity,

(b)withdraw the radio equipment, or

(c)recall the radio equipment.

(2) Where the radio equipment presents a risk, the distributor must immediately inform the market surveillance authority, and the competent national authorities of the other [F327relevant states] in which the distributor has made the radio equipment available on the market, of that risk, giving details of—

(a)the respect in which the radio equipment is considered not to be in conformity with Part 2, and

(b)any corrective measures taken.

Extent Information

E112This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Provision of information and cooperationE+W+S

35.—(1) Further to a reasoned request from an enforcing authority F87..., a distributor, within such period as the authority may specify, must provide the authority with all the information and documentation necessary to demonstrate that the radio equipment is in conformity with Part 2.

(2) A request referred to in paragraph (1)—

(a)may only be made during the period of 10 years beginning on the day on which the radio equipment was made available on the market, and

(b)must be accompanied by the reasons for making the request.

(3) The information referred to in paragraph (1)—

(a)may be provided in electronic form, and

(b)must be in a language which can be easily understood by the [F88enforcing authority].

(4) A distributor must, at the request of the enforcing authority or F89..., cooperate with the authority on any action taken to—

(a)evaluate radio equipment in accordance with regulation 59 (evaluation of radio equipment presenting a risk), and

(b)eliminate the risks posed by radio equipment which the distributor has made available on the market.

Extent Information

E23This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Provision of information and cooperationN.I.

35.—(1) Further to a reasoned request from an enforcing authority or a competent national authority of another [F328relevant state], a distributor, within such period as the authority may specify, must provide the authority with all the information and documentation necessary to demonstrate that the radio equipment is in conformity with Part 2.

(2) A request referred to in paragraph (1)—

(a)may only be made during the period of 10 years beginning on the day on which the radio equipment was made available on the market, and

(b)must be accompanied by the reasons for making the request.

(3) The information referred to in paragraph (1)—

(a)may be provided in electronic form, and

(b)must be in a language which can be easily understood by the authority concerned.

(4) A distributor must, at the request of the enforcing authority or a competent national authority of another [F328relevant state], cooperate with the authority on any action taken to—

(a)evaluate radio equipment in accordance with regulation 59 (evaluation of radio equipment presenting a risk), and

(b)eliminate the risks posed by radio equipment which the distributor has made available on the market.

Extent Information

E113This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

CHAPTER 5U.K.Importers and distributors

Cases in which obligations of manufacturers apply to importers and distributorsU.K.

36.  An economic operator (“A”) who would, but for this regulation, be considered an importer or distributor, is to be considered a manufacturer for the purposes of these Regulations and is subject to the obligations of a manufacturer under Part 2, where A—

(a)places radio equipment on the market under A's own name or trademark, or

(b)modifies radio equipment already placed on the market in such a way that it may affect whether the radio equipment is in conformity with Part 2.

[F90Obligations which are met by complying with obligations in the DirectiveE+W+S

36A.—(1) In this regulation—

(a)any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;

(b)“CE marking” has the meaning given to it in Article 2(26);

(c)“harmonised standard” has the meaning given to it in Article 2(18).

(2) Subject to paragraphs (6) and (7), paragraph (3) applies where, before placing radio equipment on the market, the manufacturer—

(a)ensures that the radio equipment has been designed and manufactured in accordance with the essential safety requirements set out in Article 3;

(b)ensures that the conformity assessment procedure that applies to that radio equipment in accordance with Article 17 of the Directive has been carried out;

(c)affixes a CE marking and where the conformity assessment procedure set out in Annex IV is applied, the notified body identification number, in accordance with Articles 19 and 20(1) to (3);

(d)draws up the technical documentation in accordance with Article 21;

(e)ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedures are prepared in or translated into English;

(f)draws up an EU declaration of conformity, in accordance with Article 18; and

(g)ensures that the EU declaration of conformity is prepared in or translated into English.

(3) Where this paragraph applies—

(a)the requirements of regulations 7, 9, 10(1) and (3) are to be treated as being satisfied;

(b)regulations 2(2)(a), 10(2), 11, 19(3) and 39 apply subject to the modifications in paragraph (8);

(c)Part 3 does not apply; and

(d)regulation 63 does not apply.

(4) Subject to paragraphs (6) and (7) paragraph (5) applies where, before placing radio equipment on the market, the importer ensures that—

(a)the conformity assessment procedure that applies to that radio equipment in accordance with Article 17 has been carried out;

(b)the manufacturer has drawn up the technical documentation referred to in Annex V; and

(c)the radio equipment bears the CE marking referred to Article 19.

(5) Where this paragraph applies—

(a)the requirements of regulation 21(a) to (d) are to be treated as being satisfied; and

(b)regulations 2(2)(a), 22(1), 25 and 28 apply subject to the modifications in paragraph (10).

(6) This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard as referred to in Article [F9117].

(7) Where paragraph (6) applies paragraphs (2)(b) and (4)(a) are to be treated as requiring the manufacturer to have carried out—

(a)one of the conformity assessment procedures in Article 17(1) with respect to the essential requirements set out in Article 3(1); and

(b)the conformity assessment procedure in Article 17(4) with respect to the essential requirements set out in Article 3(2) and (3).

(8) Paragraph (9) applies where, before making radio equipment available on the market, a distributor ensures that the radio equipment bears the CE marking referred to in Article 19.

(9) Where this paragraph applies—

(a)regulation 31(a)(i) is satisfied; and

(b)regulations 32(1) and 33 apply subject to the modifications in paragraph (10).

(10) The modifications referred to in sub-paragraphs (3)(b), (5)(b) and (8)(b) are that—

(a)any reference to “declaration of conformity” is to be read as a reference to the EU declaration of conformity;

(b)any reference to “UK marking” is to be read as a reference to the CE marking;

(c)any reference to “essential safety requirements” is to be read as a reference to the essential safety requirements set out in Article 3;

(d)any reference to “designated standard” is to be read as a reference to a harmonised standard within the meaning of Article 2(18);

(e)any reference to “relevant conformity assessment procedure” is to be read as a reference to the conformity assessment procedure that applies to the radio equipment in accordance with Article 17;

(f)any reference to “technical documentation” is a reference to the technical documentation referred to in Annex V.]

Textual Amendments

[F90[F92Further use of UK markingE+W+S

36B.—(1) In this regulation—

(a)any reference to an Article or an Annex is a reference to an Article or an Annex of the Directive;

(b)“harmonised standard” has the meaning given to it in Article 2(18).

(2) Subject to paragraphs (4) and (5), paragraph (3) applies where, before placing radio equipment on the market, the manufacturer—

(a)ensures that the radio equipment has been designed and manufactured in accordance with the essential requirements set out in Article 3;

(b)ensures that the conformity assessment procedure that applies to that radio equipment in accordance with Article 17 has been carried out;

(c)draws up the technical documentation in accordance with Article 21; and

(d)ensures that the technical documentation and other records and correspondence relating to the conformity assessment procedure are prepared in or translated into English.

(3) Where this paragraph applies—

(a)regulations 7, 9 and 45 are to be treated as being satisfied;

(b)except for regulations 42, 43 and 44(1) to (3), Part 3 does not apply;

(c)regulations 2(2)(a), 11, 17, 20, 21(a) and (c), 22, 25, 28, 32, 33, 39, 42, 44 and 63 apply subject to the modifications in paragraph (6);

(d)regulation 10 and Schedule 6 apply subject to the modifications in paragraphs (6) and (7);

(e)Schedule 7 applies subject to the modification in paragraph (7).

(4) This paragraph applies where there is no designated standard or part of a designated standard which corresponds exactly to a harmonised standard or part of a harmonised standard referred to in Article 17.

(5) Where paragraph (4) applies, paragraph (2)(b) is to be treated as requiring the manufacturer, when assessing the compliance with the essential requirements set out in Article 3(2) and (3), to ensure either of the conformity assessment procedures set out in Article 17(4) is carried out.

(6) The modifications referred to in paragraph (3)(c) and (d) are that—

(a)any reference to the “essential requirements” is to be read as a reference to the essential requirements set out in Article 3;

(b)any reference to “designated standard” is to be read as a reference to a harmonised standard;

(c)any reference to “relevant conformity assessment procedure” is to be read as a reference to the conformity assessment procedure that applies to that radio equipment in accordance with Article 17;

(d)any reference to “technical documentation” is to be read as a reference to the technical documentation referred to in Annex V.

(7) The modifications referred to in paragraph (3)(d) and (e) are that—

(a)in regulation 10 the references to “enactment” are to be read as including the Directive;

(b)in Schedule 6 any reference to “approved body” is to be read as a reference to the conformity assessment body that undertook the relevant conformity assessment procedure in accordance with Article 17;

(c)in Schedules 6 and 7 the references to “relevant statutory requirements” are to be read as including the Directive.]]

Textual Amendments

[F90Qualifying Northern Ireland GoodsE+W+S

36C.—(1) Where paragraph (2) applies radio equipment is to be treated as being in conformity with Part 2.

(2) This paragraph applies where—

(a)radio equipment—

(i)is in conformity with Part 2, as that Part applies in Northern Ireland; and

(ii)is qualifying Northern Ireland goods; and

(b)an importer has complied with the obligations set out in paragraph (3).

(3) The obligations referred to in paragraph (2)(b) are that, before placing the product on the market, the importer—

(a)complies with regulation 23;

(b)ensures that—

(i)the relevant conformity assessment procedure has been carried out in relation to the product;

(ii)the manufacturer has drawn up the technical documentation; and

(iii)the product bears the CE marking;

(4) In this regulation—

“CE marking” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland;

“qualifying Northern Ireland goods” has the meaning given to it in regulations made under section 8C(6) of the European Union (Withdrawal) Act 2018;

“relevant conformity assessment procedure” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland;

“technical documentation” has the meaning given to it in regulation 2(1), as it applies in Northern Ireland.]

Textual Amendments

CHAPTER 6U.K.All economic operators

Translation of declaration of conformityU.K.

[F9337.—(1) Before placing radio equipment on the market or making radio equipment available on the market, an economic operator must ensure that the EU declaration of conformity and, where appropriate, the simplified EU declaration of conformity is prepared in, or translated into, the language required by the [F94relevant state] in which it is to be placed on the market or made available on the market.

(2) Where the radio equipment is to be placed on the market or made available on the market in [F95Northern Ireland], the language required is English.]

Textual Amendments

Identification of economic operatorsU.K.

38.—(1) An economic operator (“E”), who receives a request from the market surveillance authority before the end of the relevant period, must, within such period as the authority may specify, identify to the authority—

(a)any economic operator who has supplied E with radio equipment, and

(b)any economic operator to whom E has supplied radio equipment.

(2) The relevant period is—

(a)for information under paragraph (1)(a), 10 years beginning on the day on which E was supplied with the radio equipment,

(b)for information under paragraph (1)(b), 10 years beginning on the day on which E supplied the radio equipment.

Prohibition on improper use of [F96UK] markingE+W+S

39.—(1) An economic operator must not affix the [F97UK] marking to radio equipment unless—

(a)that economic operator is the manufacturer, and

(b)the conformity of the radio equipment with the essential requirements has been demonstrated by a relevant conformity assessment procedure.

(2) An economic operator must not affix to radio equipment a marking other than the [F97UK] marking which purports to attest that the radio equipment is in conformity with the essential requirements.

(3) An economic operator must not affix to radio equipment a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the [F97UK] marking.

(4) An economic operator must not affix to radio equipment any other marking if the visibility, legibility and meaning of the [F97UK] marking would be impaired as a result.

Extent Information

E24This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Prohibition on improper use of CE markingN.I.

39.—(1) An economic operator must not affix the CE marking to radio equipment unless—

(a)that economic operator is the manufacturer, and

(b)the conformity of the radio equipment with the essential requirements has been demonstrated by a relevant conformity assessment procedure.

(2) An economic operator must not affix to radio equipment a marking other than the CE marking which purports to attest that the radio equipment is in conformity with the essential requirements.

(3) An economic operator must not affix to radio equipment a marking, sign or inscription which is likely to mislead any other person as to the meaning or form of the CE marking.

(4) An economic operator must not affix to radio equipment any other marking if the visibility, legibility and meaning of the CE marking would be impaired as a result.

Extent Information

E114This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

PART 3U.K.Conformity assessment

Presumption of conformityE+W+S

40.—(1) Radio equipment which is in conformity with a [F98designated] standard (or part of such a standard), F99... must be presumed to be in conformity with the essential requirements covered by that standard (or that part of that standard).

(2) The presumption in paragraph (1) is rebuttable.

Extent Information

E25This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Presumption of conformityN.I.

40.—(1) Radio equipment which is in conformity with a harmonised standard (or part of such a standard), the reference to which has been published in the Official Journal, must be presumed to be in conformity with the essential requirements covered by that standard (or that part of that standard).

(2) The presumption in paragraph (1) is rebuttable.

Extent Information

E115This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Conformity assessment proceduresE+W+S

41.—(1) The manufacturer must perform a conformity assessment of the radio equipment, in all its possible configurations, with a view to meeting the essential requirements.

(2) The conformity assessment must take into account all intended operating conditions.

(3) In relation to the assessment of compliance with regulation 6(1)(a), the conformity assessment must also take into account all reasonably foreseeable conditions.

(4) In relation to the assessment of compliance with regulation 6(1)(a) or (b), one of the following procedures must be used—

(a)internal production control set out in Schedule 2 (conformity assessment module A),

(b)F100...type examination that is followed by the conformity to type based on internal production control set out in Schedule 3 (conformity assessment modules B and C),

(c)conformity based on full quality assurance set out in Schedule 4 (conformity assessment module H).

(5) In relation to the assessment of compliance with regulation 6(2), where the manufacturer has applied [F101designated] standards, F102... the manufacturer must use one of the procedures in paragraph (4) for the conformity assessment.

(6) In relation to the assessment of compliance with regulation 6(2), where the manufacturer has not applied or has only partly applied [F103designated] standards, F104... or where [F103designated] standards do not exist, the manufacturer must use the procedure in either paragraph (4)(b) or paragraph (4)(c).

Extent Information

E26This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Conformity assessment proceduresN.I.

41.—(1) The manufacturer must perform a conformity assessment of the radio equipment, in all its possible configurations, with a view to meeting the essential requirements.

(2) The conformity assessment must take into account all intended operating conditions.

(3) In relation to the assessment of compliance with regulation 6(1)(a), the conformity assessment must also take into account all reasonably foreseeable conditions.

(4) In relation to the assessment of compliance with regulation 6(1)(a) or (b), one of the following procedures must be used—

(a)internal production control set out in Schedule 2 (conformity assessment module A),

(b)EU-type examination that is followed by the conformity to type based on internal production control set out in Schedule 3 (conformity assessment modules B and C),

(c)conformity based on full quality assurance set out in Schedule 4 (conformity assessment module H).

(5) In relation to the assessment of compliance with regulation 6(2) [F329or (3)], where the manufacturer has applied harmonised standards, the references of which have been published in the Official Journal, the manufacturer must use one of the procedures in paragraph (4) for the conformity assessment.

(6) In relation to the assessment of compliance with regulation 6(2) [F330or (3)], where the manufacturer has not applied or has only partly applied harmonised standards, the references of which have been published in the Official Journal, or where harmonised standards do not exist, the manufacturer must use the procedure in either paragraph (4)(b) or paragraph (4)(c).

Extent Information

E116This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

[F105Declaration] of conformityE+W+S

42.  The F106... declaration of conformity for radio equipment must—

(a)state that the fulfilment of the essential requirements has been demonstrated in respect of that radio equipment,

(b)contain the elements specified and have the model structure set out in Schedule 6 (F107... declaration of conformity) for the relevant conformity assessment procedure followed in respect of that radio equipment.

Extent Information

E27This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

EU declaration of conformityN.I.

42.  The EU declaration of conformity for radio equipment must—

(a)state that the fulfilment of the essential requirements has been demonstrated in respect of that radio equipment,

(b)contain the elements specified and have the model structure set out in Schedule 6 (EU declaration of conformity) for the relevant conformity assessment procedure followed in respect of that radio equipment.

Extent Information

E117This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Simplified F108... declaration of conformityE+W+S

43.—(1) Where only a simplified F109... declaration of conformity is provided pursuant to regulation 13(3), it must contain the elements specified and have the model structure set out in Schedule 7 (simplified F109... declaration of conformity).

(2) The full text of the F109... declaration of conformity must be made available at the internet address referred to in the simplified F109... declaration of conformity.

Extent Information

E28This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Simplified EU declaration of conformityN.I.

43.—(1) Where only a simplified EU declaration of conformity is provided pursuant to regulation 13(3), it must contain the elements specified and have the model structure set out in Schedule 7 (simplified EU declaration of conformity).

(2) The full text of the EU declaration of conformity must be made available at the internet address referred to in the simplified EU declaration of conformity.

Extent Information

E118This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F110UK] markingE+W+S

44.—[F111(1) The UK marking must be affixed visibly, legibly and indelibly—

(a)to the radio equipment or to its data plate, unless that is not possible or not warranted on account of the radio equipment; or

(b)where paragraph (1A) applies—

(i)to a label affixed to the radio equipment or its data plate; or

(ii)to a document accompanying the radio equipment.]

[F112(1A) For a period of [F113seven years] beginning with IP completion day, the UK marking may be affixed to—

(a)a label affixed to the radio equipment or its data plate; or

(b)a document accompanying the radio equipment.]

[F114(2) The UK marking must be affixed visibly and legibly—

(a)to the radio equipment packaging; or

(b)where paragraph (2A) applies—

(i)to a label affixed to the radio equipment packaging; or

(ii)a document accompanying the radio equipment packaging.]

[F115(2A) For a period of [F116seven years] beginning with IP completion day, the UK marking may be affixed to—

(a)a label affixed to the radio equipment packaging; or

(b)a document accompanying the radio equipment packaging.]

(3) On account of the nature of the radio equipment, the height of the [F117UK] marking affixed to radio equipment may be lower than 5 mm, provided that the marking remains visible and legible.

(4) When the conformity assessment procedure in Schedule 4 (conformity assessment module H) has been applied, the [F117UK] marking must be followed by the identification number of the [F118approved body] which carried out the relevant conformity assessment procedure for the radio equipment.

(5) The identification number in paragraph (4) must have the same height as the [F117UK] marking and be affixed—

(a)by the [F118approved body] itself, or

(b)under the instructions of the [F118approved body], by the manufacturer or the manufacturer's authorised representative.

Extent Information

E29This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

CE markingN.I.

44.—(1) The CE marking must be affixed visibly, legibly and indelibly to the radio equipment or to its data plate, unless that is not possible or not warranted on account of the nature of the radio equipment.

(2) The CE marking must be affixed visibly and legibly to the radio equipment packaging.

(3) On account of the nature of the radio equipment, the height of the CE marking affixed to radio equipment may be lower than 5 mm, provided that the marking remains visible and legible.

(4) When the conformity assessment procedure in Schedule 4 (conformity assessment module H) has been applied, the CE marking must be followed by the identification number of the notified body which carried out the relevant conformity assessment procedure for the radio equipment.

(5) The identification number in paragraph (4) must have the same height as the CE marking and be affixed—

(a)by the notified body itself, or

(b)under the instructions of the notified body, by the manufacturer or the manufacturer's authorised representative.

Extent Information

E119This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F119UK(NI) indicationN.I.

44A.—(1) Where the CE marking is affixed on the basis of an assessment or a certificate issued by a notified body established in the United Kingdom, a UK(NI) indication must be affixed in relation to the radio equipment, in accordance with this regulation.

(2) The UK(NI) indication must be affixed—

(a)visibly, legibly and indelibly; and

(b)before the radio equipment is placed on the market in Northern Ireland.

(3) The UK(NI) indication must accompany the CE marking, wherever that is affixed in accordance with regulation 44.

(4) The UK(NI) indication must be affixed by—

(a)the manufacturer; or

(b)the manufacturer's authorised representative.

(5) When placing radio equipment on the market in Northern Ireland, an importer must ensure that the manufacturer has complied with their obligations under this regulation.]

Textual Amendments

[F119Register of notified bodies established in the United KingdomN.I.

44B.—(1) The Secretary of State must ensure that—

(a)each notified body established in the United Kingdom is assigned an identification number; and

(b)there is a register of—

(i)notified bodies established in the United Kingdom;

(ii)their notified body identification number;

(iii)the activities for which they have been notified;

(iv)any restrictions on those activities.

(2) The Secretary of State must ensure that the register referred to in paragraph (1) is maintained and made publicly available.

(3) The Secretary of State may authorise the United Kingdom Accreditation Service to compile and maintain the register in accordance with paragraph (1)(b).]

Textual Amendments

Technical documentationE+W+S

45.—(1) The technical documentation produced by the manufacturer for the radio equipment must contain all the relevant data or details of the means used by the manufacturer to ensure that the radio equipment complies with the essential requirements.

(2) The technical documentation in paragraph (1) must—

(a)contain, at least, the elements set out in Schedule 5 (contents of technical documentation),

(b)be drawn up before the radio equipment is placed on the market, and

(c)be continuously updated.

F120(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) Where the technical documentation does not comply with the requirements in [F121paragraphs (1) and (2)] and in doing so fails to present sufficient relevant data or details of the means used to ensure compliance of radio equipment with the essential requirements, the market surveillance authority may ask the manufacturer or importer to have a test performed, within a specified period, by a body acceptable to the market surveillance authority, at the expense of the manufacturer or the importer to verify conformity with the essential requirements.

Extent Information

E30This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Technical documentationN.I.

45.—(1) The technical documentation produced by the manufacturer for the radio equipment must contain all the relevant data or details of the means used by the manufacturer to ensure that the radio equipment complies with the essential requirements.

(2) The technical documentation in paragraph (1) must—

(a)contain, at least, the elements set out in Schedule 5 (contents of technical documentation),

(b)be drawn up before the radio equipment is placed on the market, and

(c)be continuously updated.

(3) The technical documentation in paragraph (1) and correspondence relating to any EU-type examination procedure must be drawn up in an official language of the [F331relevant state] in which the notified body is established or in a language acceptable to that body.

(4) Where the technical documentation does not comply with the requirements in paragraphs (1), (2) or (3) and in doing so fails to present sufficient relevant data or details of the means used to ensure compliance of radio equipment with the essential requirements, the market surveillance authority may ask the manufacturer or importer to have a test performed, within a specified period, by a body acceptable to the market surveillance authority, at the expense of the manufacturer or the importer to verify conformity with the essential requirements.

Extent Information

E120This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

PART 4U.K.[F122Notification of conformity assessment bodies] [F122Approval of conformity assessment bodies]

Textual Amendments

[F122Approved bodiesE+W+S

46.—(1) An approved body is a conformity assessment body which—

(a)has been approved by the Secretary of State pursuant to the procedure set out in regulation 47 (approval of conformity assessment bodies); or

(b)immediately before IP completion day was a notified body in respect of which the Secretary of State had taken no action under regulations 52(1) or (2), as they had effect immediately before IP completion day, to suspend or withdraw the body's status as a notified body.

(2) Paragraph (1) has effect subject to regulation 50 (restriction, suspension or withdrawal of approval).

(3) In this Part—

“notified body” means a body—

(a)

which the Secretary of State had before IP completion day notified to the European Commission and the Member States of the European Union, in accordance with Article 22 of the Directive; and

(b)

in respect of which no objections had been raised, as referred to in regulation 46(1)(b) as it had effect immediately before IP completion day;

“approved body requirements” means the requirements set out in Schedule 8.]

Extent Information

E31This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Notified bodiesN.I.

46.—(1) For the purposes of this Part, a notified body is a conformity assessment body—

(a)which has been notified by the Secretary of State to the European Commission and to the other [F332relevant states]—

(i)under regulation 47 (notification), or

(ii)before the commencement date, in accordance with Article 22 of the Directive, and

(b)in respect of which no objections [F333, other than an immaterial objection,] are raised by the European Commission or other [F334relevant states]—

(i)within 2 weeks of the date of notification, where the notification is accompanied by an accreditation certificate, or

(ii)within 2 months of the date of notification, where the notification is not accompanied by an accreditation [F335certificate;]

[F336(c)in sub-paragraph (b), an “immaterial objection” is an objection on the grounds that—

(i)the conformity assessment body is established in the United Kingdom; or

(ii)the accreditation certificate was issued by the United Kingdom Accreditation Service.]

(2) Paragraph (1) has effect subject to regulation 52 (changes to notifications).

Extent Information

E121This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

[F122Approval of conformity assessment bodiesE+W+S

47.—(1) The Secretary of State may approve only those conformity assessment bodies that qualify for approval.

(2) A conformity assessment body qualifies for approval if the first and second conditions below are met.

(3) The first condition is that the conformity assessment body has applied to the Secretary of State to become an approved body and that application is accompanied by—

(a)a description of—

(i)the conformity assessment activities that the conformity assessment body intends to carry out;

(ii)the conformity assessment procedure in respect of which the conformity assessment body claims to be competent;

(iii)the radio equipment in respect of which the conformity assessment body claims to be competent; and

(b)either—

(i)an accreditation certificate; or

(ii)the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the conformity assessment body's compliance with the approved body requirements.

(4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the approved body requirements.

(5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the conformity assessment body meets the approved body requirements.

(6) When deciding whether to approve a conformity assessment body that qualifies for approval, the Secretary of State may—

(a)have regard to any other matter which appears to the Secretary of State to be relevant; and

(b)set conditions that the conformity assessment body must meet.

(7) For the purposes of this regulation “accreditation certificate” means a certificate, issued by the UK national accreditation body, attesting that a conformity assessment body meets the approved body requirements.]

Extent Information

E32This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

NotificationN.I.

47.—(1) The Secretary of State may notify to the European Commission and the other [F337relevant states] only those conformity assessment bodies that qualify for notification.

(2) A conformity assessment body qualifies for notification if the first and the second conditions below are met.

(3) The first condition is that the conformity assessment body applied to the Secretary of State to become a notified body and that application was accompanied by—

(a)a description of—

(i)the conformity assessment activities that the body intends to carry out,

(ii)the conformity assessment module or modules for which the body claims to be competent, and

(iii)the radio equipment for which the body claims to be competent, and

(b)either—

(i)an accreditation certificate, or

(ii)the documentary evidence necessary for the Secretary of State to verify, recognise and regularly monitor the body's compliance with the notified body requirements.

(4) The second condition is that the Secretary of State is satisfied that the conformity assessment body meets the notified body requirements.

(5) For the purposes of paragraph (4), the Secretary of State may accept an accreditation certificate, provided in accordance with paragraph (3)(b), as sufficient evidence that the conformity assessment body meets the notified body requirements.

(6) When deciding whether to notify a conformity assessment body that qualifies for notification to the European Commission and the other [F337relevant states], the Secretary of State may—

(a)have regard to any other matter which appears to the Secretary of State to be relevant, and

(b)set conditions that the conformity assessment body must meet.

(7) The Secretary of State must inform the European Commission of the United Kingdom's procedures for the assessment and notification of conformity assessment bodies, and any changes to those procedures.

Extent Information

E122This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

[F122Presumption of conformity of approved bodiesE+W+S

48.—(1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a designated standard (or part of such standard), the Secretary of State is to presume that the conformity assessment body meets the approved body requirements covered by that standard (or that part of that standard).

(2) The presumption in paragraph (1) is rebuttable.]

Extent Information

E33This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Presumption of conformity of notified bodiesN.I.

48.—(1) Where a conformity assessment body demonstrates its conformity with the criteria laid down in a harmonised standard (or part of such a standard), the reference of which has been published in the Official Journal, the Secretary of State must presume that the conformity assessment body meets the notified body requirements covered by that standard (or part of that standard).

(2) The presumption in paragraph (1) is rebuttable.

Extent Information

E123This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F122MonitoringE+W+S

49.  The Secretary of State must monitor each approved body with a view to verifying that the body—

(a)continues to meet the approved body requirements;

(b)meets any conditions set—

(i)in accordance with regulation 47(6)(b); or

(ii)in the case of an approved body which was a notified body immediately before IP completion day, in accordance with regulation 47(6)(b), as it applied immediately before IP completion day; and

(c)carries out its functions in accordance with these Regulations.]

Extent Information

E34This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Contents of notificationN.I.

49.  A notification under regulation 47 (notification) must include—

(a)details of—

(i)the conformity assessment activities,

(ii)the conformity assessment module,

(iii)the radio equipment,

in respect of which the conformity assessment body has been approved by the Secretary of State for notification, and

(b)either—

(i)an accreditation certificate, where the notification is based on the accreditation, or

(ii)documentary evidence which attests to the conformity assessment body's competence, and to the arrangements in place to ensure that the conformity assessment body will be monitored regularly and will continue to meet the notified body requirements.

Extent Information

E124This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F122Restriction, suspension or withdrawal of approvalE+W+S

50.—(1) Where the Secretary of State determines that an approved body—

(a)no longer meets an approved body requirement, or

(b)is failing to fulfil its obligations under these Regulations, other than a condition referred to in regulation 49(b),

the Secretary of State must restrict, suspend or withdraw the body's status as an approved body under regulation 46 (approved bodies).

(2) Where the Secretary of State determines that an approved body no longer meets a condition referred to in regulation 49(b), the Secretary of State may restrict, suspend or withdraw the body's status as an approved body under regulation 46.

(3) In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the non-compliance.

(4) Before taking action under paragraph (1) or (2), the Secretary of State must—

(a)give notice in writing to the approved body of the proposed action and the reasons for it;

(b)give the approved body an opportunity to make representations to the Secretary of State regarding the proposed action within a reasonable period from the date of the notice; and

(c)consider any such representations made by the approved body.

(5) Where the Secretary of State has taken action in respect of an approved body under paragraph (1) or (2), or where an approved body has ceased its activity, the approved body must, at the request of the Secretary of State—

(a)transfer its files relating to the activities it has undertaken as an approved body to another approved body or to the Secretary of State; or

(b)keep its files relating to the activities it has undertaken as an approved body available for the Secretary of State and market surveillance authorities for a period of 10 years from the date they were created.

(6) The activities undertaken as an approved body referred to in paragraph (5) include any activities that the body has undertaken as a notified body.]

Extent Information

E35This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

MonitoringN.I.

50.—(1) The Secretary of State must monitor each notified body with a view to verifying that the notified body—

(a)continues to meet the notified body requirements,

(b)meets any conditions set in accordance with regulation 47(6)(b), and

(c)carries out its functions in accordance with these Regulations.

(2) The Secretary of State must inform the European Commission of the United Kingdom's procedures for the monitoring of notified bodies, and any changes to those procedures.

Extent Information

E125This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F122Operational matters in relation to approved bodiesE+W+S

51.—(1) Subject to the terms of its appointment, an approved body must carry out the conformity assessment activities and procedures—

(a)in respect of which the body's approval was given under regulation 47; or

(b)in respect of which body's notification as a notified body was made.

(2) Where an approved body carries out a conformity assessment procedure, it must do so in accordance with Schedule 9.

(3) An approved body must make provision for a manufacturer to be able to make an appeal against a refusal by the approved body—

(a)to issue a Type-examination certificate referred to in Schedule 3; or

(b)to affix, or cause to be affixed, the body's identification number pursuant to regulation 44(5) (UK marking).]

Extent Information

E36This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

United Kingdom Accreditation ServiceN.I.

51.  The Secretary of State may authorise the United Kingdom Accreditation Service (a company limited by guarantee incorporated in England and Wales under number 03076190) to carry out the following activities on behalf of the Secretary of State—

(a)assessing whether a conformity assessment body meets the notified body requirements,

(b)monitoring notified bodies in accordance with regulation 50 (monitoring).

Extent Information

E126This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F122Subsidiaries and contractorsE+W+S

52.—(1) An approved body may subcontract specific conformity assessment activities, or use a subsidiary to carry out such activities provided—

(a)the body is satisfied that the subcontractor or subsidiary meets the approved body requirements;

(b)the body has informed the Secretary of State that it is satisfied that the subcontractor or subsidiary meets those requirements; and

(c)the economic operator for whom the activities are to be carried out has consented to the activities being carried out by that person.

(2) The approved body which subcontracts specific conformity assessment activities or uses a subsidiary to carry out such activities remains responsible for the proper performance of those activities (irrespective of where the subcontractor or subsidiary is established).

(3) Where an approved body subcontracts, or uses a subsidiary to carry out, a specific conformity assessment activity, the approved body must, for a period of 10 years beginning on the day on which the activity is first carried out, keep available for inspection by the Secretary of State all relevant documentation concerning—

(a)the assessment of the qualifications of the subcontractor or the subsidiary; and

(b)the conformity assessment activity carried out by the subcontractor or subsidiary.

(4) In this regulation, “subsidiary” has the meaning given to it in section 1159 of the Companies Act 2006.]

Extent Information

E37This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Changes to notificationsN.I.

52.—(1) The Secretary of State must restrict, suspend or withdraw a notified body's status as a notified body under regulation 46 where the Secretary of State determines that the body—

(a)no longer meets a notified body requirement, or

(b)is failing to fulfil its obligations under these Regulations, other than a condition set in accordance with regulation 47(6)(b).

(2) The Secretary of State may restrict, suspend or withdraw the notified body's status as a notified body under regulation 46—

(a)with the consent of a notified body, or

(b)where the Secretary of State determines that a notified body no longer meets a condition set in accordance with regulation 47(6)(b).

(3) In deciding what action is required under paragraph (1) or (2), the Secretary of State must have regard to the seriousness of the failure.

(4) Before taking action under paragraph (1) or (2), the Secretary of State must—

(a)give notice in writing to the notified body that the Secretary of State intends to take such action and the reasons for taking such action, and

(b)give the notified body an opportunity to make representations within a reasonable period from the date of that notice and consider any such representations.

(5) Where the Secretary of State takes action under paragraph (1) or (2), the Secretary of State must immediately inform the European Commission and the other [F338relevant states].

(6) Where the Secretary of State has taken action in respect of a notified body under paragraph (1) or (2), or where a notified body has ceased its activity, the body must—

(a)as directed by the Secretary of State, transfer its files relating to the activities it has undertaken as a notified body to another notified body or to the Secretary of State, or

(b)keep the documents relating to the activities it has undertaken as a notified body available for the Secretary of State and the enforcing authority for a period of 10 years from the date on which the product to which the document relates was placed on the market.

Extent Information

E127This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

[F122Register of approved bodiesE+W+S

53.—(1) The Secretary of State must—

(a)assign an approved body identification number to each approved body; and

(b)compile and maintain a register of—

(i)approved bodies;

(ii)their approved body identification numbers;

(iii)the activities for which they have been approved; and

(iv)any restrictions on those activities.

(2) The register referred to in paragraph (1) must be made publicly available.]

Extent Information

E38This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Operational obligations of notified bodiesN.I.

53.  When a notified body carries out a relevant conformity assessment procedure, Schedule 9 (operational obligations of notified bodies) has effect.

Extent Information

E128This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F122UK national accreditation bodyE+W+S

54.  The Secretary of State may authorise the UK national accreditation body to carry out the following activities on behalf of the Secretary of State—

(a)assessing whether a conformity assessment body meets the approved body requirements;

(b)monitoring approved bodies in accordance with regulation 49; and

(c)compiling and maintaining the register of approved bodies, in accordance with regulation 53.]

Extent Information

E39This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Subsidiaries and contractorsN.I.

54.—(1) Where a notified body subcontracts specific conformity assessment activities, or has such activities carried out by a subsidiary, the activities are only to be treated as having been carried out by a notified body for the purposes of regulation 41 (conformity assessment procedures) where the conditions in paragraphs (2) and (3) are met.

(2) The notified body must—

(a)ensure that the subcontractor or subsidiary satisfies the notified body requirements, and

(b)inform the Secretary of State accordingly.

(3) The notified body must have obtained the agreement of the client to the use of a subcontractor or subsidiary.

(4) Where a notified body subcontracts specific conformity assessment activities, or has such activities carried out by a subsidiary, the notified body must for a period of at least 10 years beginning on the day on which the activities are carried out, keep available for inspection by the Secretary of State all the relevant documentation concerning—

(a)the assessment of the qualifications of the subcontractor or the subsidiary, and

(b)the conformity assessment activities carried out by the subcontractor or subsidiary under Schedule 3 (conformity assessment modules B and C) or Schedule 4 (conformity assessment module H).

(5) When monitoring a notified body in accordance with regulation 50, the Secretary of State must treat the notified body as responsible for the activities performed by a subcontractor or subsidiary, wherever the subcontractor or subsidiary is established.

Extent Information

E129This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

PART 5U.K.Market surveillance and enforcement

Designation of market surveillance authoritiesU.K.

55.—(1) The market surveillance authority is—

(a)within its area in Great Britain, the weights and measures authority, and

(b)within its area in Northern Ireland, the district council.

(2) The market surveillance authority must make adequate arrangements for market surveillance under these Regulations and RAMS (in its application to radio equipment).

(3) When a market surveillance authority carries out market surveillance under these Regulations, Part 2 of Schedule 10 (notices which may be served by enforcing authorities) has effect.

Designation of enforcing authoritiesU.K.

56.—(1) It is the duty of the following authorities to enforce these Regulations and RAMS (in its application to radio equipment)—

(a)in Great Britain—

(i)OFCOM, insofar as action taken to enforce these Regulations relates to the protection and management of the radio spectrum,

(ii)within their area, the weights and measures authorities.

(b)in Northern Ireland—

(i)OFCOM, insofar as action taken to enforce these Regulations relates to the protection and management of the radio spectrum,

(ii)within their area, the district councils.

(2) The Secretary of State, or a person appointed by the Secretary of State to act on behalf of the Secretary of State, may enforce these Regulations and RAMS (in its application to radio equipment).

(3) In Scotland, only the Lord Advocate may commence proceedings for an offence.

Enforcement powersE+W+S

57.—(1) For the purposes of enforcing these Regulations, Schedule 10 (enforcement and investigatory powers) applies.

(2) Where the enforcing authority has reasonable grounds to suspect that the [F123UK] marking has been affixed to radio equipment which does not satisfy the essential requirements, it may serve a compliance notice on—

(a)the manufacturer, if the manufacturer is established in the United Kingdom,

(b)the manufacturer's authorised representative in the United Kingdom, or

(c)the importer.

(3) Where a compliance notice is served in accordance with paragraph (2), no other notice as referred to in Part 2 of Schedule 10 can be issued and no proceedings pursuant to regulation 63 (enforcement action in respect of formal non-compliance) can be brought, until the person on whom that notice has been served has failed to comply with its requirements.

(4) A compliance notice must—

(a)state that the enforcing authority suspects that the [F123UK] marking has been affixed pursuant to regulation 44 ([F123UK] marking) in circumstances where that radio equipment does not comply with the requirements of these Regulations,

(b)state the reasons for that suspicion,

(c)identify the requirements with which it is suspected that the radio equipment does not comply,

(d)specify a date by which any necessary action to remedy non-compliance must have been taken,

(e)require the person on whom the notice is served to—

(i)take the necessary action to ensure that the radio equipment to which the notice relates conforms with the requirements of these Regulations and RAMS concerning the [F123UK] marking and to end the infringement by the date specified in the notice, or

(ii)to provide evidence, by the date specified in the notice, that demonstrates to the satisfaction of the enforcement authority that all provisions of these Regulations which apply to the radio equipment have been complied with, and

(f)warn the person on whom the notice is served that if the radio equipment does not comply with the requirements of these Regulations by the date specified in the notice, further enforcement action may be taken under these Regulations in respect of the radio equipment referred to in the notice or any radio equipment of the same type placed on the market by that person.

(5) A compliance notice may include directions as to the measures to be taken by the person upon whom it is served in order to ensure that the radio equipment complies with the requirements of these Regulations which apply to it, by the date specified in the notice.

(6) In this regulation, “enforcement officer” means—

(a)an officer of an enforcing authority who is authorised in writing by that authority to act as an enforcement officer for the purposes of this Part,

(b)a person appointed by the Secretary of State who is authorised in writing by the Secretary of State to act as an enforcement officer for the purposes of this Part.

Extent Information

E40This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Enforcement powersN.I.

57.—(1) For the purposes of enforcing these Regulations, Schedule 10 (enforcement and investigatory powers) applies.

(2) Where the enforcing authority has reasonable grounds to suspect that the CE marking has been affixed to radio equipment which does not satisfy the essential requirements, it may serve a compliance notice on—

(a)the manufacturer, if the manufacturer is established in the United Kingdom,

(b)the manufacturer's authorised representative in the United Kingdom, or

(c)the importer.

(3) Where a compliance notice is served in accordance with paragraph (2), no other notice as referred to in Part 2 of Schedule 10 can be issued and no proceedings pursuant to regulation 63 (enforcement action in respect of formal non-compliance) can be brought, until the person on whom that notice has been served has failed to comply with its requirements.

(4) A compliance notice must—

(a)state that the enforcing authority suspects that the CE marking has been affixed pursuant to regulation 44 (CE marking) in circumstances where that radio equipment does not comply with the requirements of these Regulations,

(b)state the reasons for that suspicion,

(c)identify the requirements with which it is suspected that the radio equipment does not comply,

(d)specify a date by which any necessary action to remedy non-compliance must have been taken,

(e)require the person on whom the notice is served to—

(i)take the necessary action to ensure that the radio equipment to which the notice relates conforms with the requirements of these Regulations and RAMS concerning the CE marking and to end the infringement by the date specified in the notice, or

(ii)to provide evidence, by the date specified in the notice, that demonstrates to the satisfaction of the enforcement authority that all provisions of these Regulations which apply to the radio equipment have been complied with, and

(f)warn the person on whom the notice is served that if the radio equipment does not comply with the requirements of these Regulations by the date specified in the notice, further enforcement action may be taken under these Regulations in respect of the radio equipment referred to in the notice or any radio equipment of the same type placed on the market by that person.

(5) A compliance notice may include directions as to the measures to be taken by the person upon whom it is served in order to ensure that the radio equipment complies with the requirements of these Regulations which apply to it, by the date specified in the notice.

(6) In this regulation, “enforcement officer” means—

(a)an officer of an enforcing authority who is authorised in writing by that authority to act as an enforcement officer for the purposes of this Part,

(b)a person appointed by the Secretary of State who is authorised in writing by the Secretary of State to act as an enforcement officer for the purposes of this Part.

Extent Information

E130This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Exercise of enforcement powersU.K.

58.  When enforcing these Regulations, the enforcing authority must exercise its powers in a manner which is consistent with—

(a)regulation 59 (evaluation of radio equipment presenting a risk),

(b)regulation 60 (enforcement action in respect of radio equipment which is not in conformity and which presents a risk),

(c)[F124regulation 61 (EU safeguard procedure),]

(d)regulation 62 (enforcement action in respect of radio equipment which is in conformity, but presents a risk),

(e)regulation 63 (enforcement action in respect of formal non-compliance),

(f)regulation 64 (restrictive measures).

Textual Amendments

Evaluation of radio equipment presenting a riskU.K.

59.—(1) Where a market surveillance authority has sufficient reason to believe that radio equipment presents a risk, that authority must carry out an evaluation in relation to the radio equipment covering the relevant requirements of Part 2 applying in respect of that radio equipment.

(2) Where an enforcing authority other than the market surveillance authority has sufficient reason to believe that radio equipment presents a risk, that authority may carry out an evaluation in relation to the radio equipment covering the relevant requirements of Part 2 applying in respect of that radio equipment.

Enforcement action in respect of radio equipment which is not in conformity and which presents a riskE+W+S

60.—(1) Where, in the course of the evaluation referred to in regulation 59, an enforcing authority finds that the radio equipment is not in conformity with Part 2, it must without delay require a relevant economic operator to—

(a)take appropriate corrective actions to bring the radio equipment into conformity with those requirements,

(b)withdraw the radio equipment, or

(c)recall the radio equipment,

within such reasonable period as the authority prescribes, which is commensurate with the nature of the risk presented by the radio equipment.

(2) The enforcing authority must inform the notified body which carried out the conformity assessment procedure in respect of the radio equipment of—

(a)the respect in which the radio equipment is not in conformity with Part 2, and

(b)the actions which the enforcing authority has required the economic operator to take.

F125(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F125(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5) Where the relevant economic operator does not take adequate corrective action within the prescribed period, the enforcing authority must take appropriate measures to—

(a)prohibit or restrict the radio equipment being made available on the market in the United Kingdom,

(b)withdraw the radio equipment from the United Kingdom market, or

(c)recall the radio equipment.

(6) Where the enforcing authority is not the Secretary of State and it takes measures under paragraph (5), it must notify the Secretary of State of those measures without delay.

F126(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(8) The [F127notification under paragraph (6)] must include details about the radio equipment and, in particular—

(a)the data necessary for the identification of the radio equipment which is not in conformity with Part 2,

(b)the origin of the radio equipment,

(c)the nature of the lack of conformity alleged and the risk involved,

(d)the nature and duration of the measures taken,

(e)the arguments put forward by the relevant economic operator, and

(f)whether the lack of conformity is due to either of the following—

(i)failure of the radio equipment to meet the essential requirements, or

(ii)shortcomings in the [F128designated] standards referred to in regulation 40 (presumption of conformity) conferring a presumption of conformity.

Extent Information

E41This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Enforcement action in respect of radio equipment which is not in conformity and which presents a riskN.I.

60.—(1) Where, in the course of the evaluation referred to in regulation 59, an enforcing authority finds that the radio equipment is not in conformity with Part 2, it must without delay require a relevant economic operator to—

(a)take appropriate corrective actions to bring the radio equipment into conformity with those requirements,

(b)withdraw the radio equipment [F339from Northern Ireland], or

(c)recall the radio equipment [F340from Northern Ireland],

within such reasonable period as the authority prescribes, which is commensurate with the nature of the risk presented by the radio equipment.

(2) The enforcing authority must inform the notified body which carried out the conformity assessment procedure in respect of the radio equipment of—

(a)the respect in which the radio equipment is not in conformity with Part 2, and

(b)the actions which the enforcing authority has required the economic operator to take.

(3) Where the enforcing authority is not the Secretary of State and it considers that the lack of conformity referred to in paragraph (1) is not restricted to [F341Northern Ireland], it must notify the Secretary of State of—

(a)the results of the evaluation, and

(b)the actions which it has required the economic operator to take.

(4) [F342Subject to paragraph (4A),] where the Secretary of State receives notification under paragraph (3), or otherwise considers that the lack of conformity referred to in paragraph (1) is not restricted to [F343Northern Ireland], the Secretary of State must inform the European Commission and the other [F344relevant states] of—

(a)the results of the evaluation, and

(b)any actions which the enforcing authority has required the economic operator to take.

[F345(4A) Paragraph (4) does not require the Secretary of State to inform the Commission or the other relevant states where the lack of conformity extends only to any of England or Wales or Scotland.]

(5) Where the relevant economic operator does not take adequate corrective action within the prescribed period, the enforcing authority must take appropriate measures to—

(a)prohibit or restrict the radio equipment being made available on the market in [F346Northern Ireland],

(b)withdraw the radio equipment from the [F347market in Northern Ireland], or

(c)recall the radio equipment.

(6) Where the enforcing authority is not the Secretary of State and it takes measures under paragraph (5), it must notify the Secretary of State of those measures without delay.

(7) Where the Secretary of State receives notification under paragraph (6), or takes measures under paragraph (5), the Secretary of State must notify the European Commission and the other [F348relevant states] of those measures without delay.

(8) The notifications under paragraphs (6) and (7) must include details about the radio equipment and, in particular—

(a)the data necessary for the identification of the radio equipment which is not in conformity with Part 2,

(b)the origin of the radio equipment,

(c)the nature of the lack of conformity alleged and the risk involved,

(d)the nature and duration of the measures taken,

(e)the arguments put forward by the relevant economic operator, and

(f)whether the lack of conformity is due to either of the following—

(i)failure of the radio equipment to meet the essential requirements, or

(ii)shortcomings in the harmonised standards referred to in regulation 40 (presumption of conformity) conferring a presumption of conformity.

Extent Information

E131This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

EU safeguard procedureU.K.

[F12961.—(1) Where another [F130relevant state] has initiated the procedure under Article 40 of the Directive (as amended from time to time), each enforcing authority (other than the Secretary of State) must, without delay, inform the Secretary of State of—

(a)any measure taken by the enforcing authority in respect of the radio equipment, and

(b)any additional information which the enforcing authority has at its disposal relating to the lack of conformity of the radio equipment.

(2) Where another [F131relevant state] has initiated the procedure under Article 40 of the Directive (as amended from time to time), the Secretary of State must, without delay, inform the European Commission and the other [F132relevant states] of—

(a)any measure taken by an enforcing authority [F133in Northern Ireland] in respect of the radio equipment,

(b)any additional information which an enforcing authority has at its disposal relating to the lack of conformity of the radio [F134equipment.]

F135(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(3) Where a measure taken by another [F136relevant state] in respect of radio equipment is deemed justified under Article 40(7) of the Directive (as amended from time to time) (no objections raised by Member States or the European Commission in respect of a provisional measure taken by an enforcing authority), the market surveillance authority must ensure that appropriate measures, such as withdrawal or recall, are taken [F137in Northern Ireland] in respect of the radio equipment without delay.

(4) Where a measure taken by another [F138relevant state] in respect of radio equipment is considered justified by the European Commission under Article 41(1) of the Directive (as amended from time to time) (consideration by the European Commission of objections raised by a Member State about, or compatibility with EU law of, measures taken by an economic operator, or a provisional measure taken by an enforcing authority), the market surveillance authority must take the necessary measures to ensure that the radio equipment is withdrawn or recalled from [F139market in Northern Ireland].

(5) Where the market surveillance authority is not the Secretary of State and the market surveillance authority has taken action under paragraph (3) or (4), it must inform the Secretary of State.

(6) Where the Secretary of State receives notification under paragraph (5) or has taken action under paragraphs (3) or (4), the Secretary of State must inform the European Commission of the action taken [F140in respect of Northern Ireland].

F141(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

Enforcement action in respect of radio equipment which is in conformity, but presents a riskE+W+S

62.—(1) Where, having carried out an evaluation under regulation 59 (evaluation of radio equipment presenting a risk), an enforcing authority finds that although the radio equipment is in conformity with Part 2, it presents a risk, the enforcing authority must require a relevant economic operator to take appropriate measures to—

(a)ensure that the radio equipment, when placed on the market, no longer presents a risk,

(b)withdraw the radio equipment within a prescribed period, or

(c)recall the radio equipment within a prescribed period.

(2) Where an enforcing authority is not the Secretary of State and it takes measures under paragraph (1), it must notify the Secretary of State immediately.

F142(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(4) The [F143notification referred to in paragraph (2)] must include details about the radio equipment and, in particular—

(a)the data necessary for the identification of the radio equipment concerned,

(b)the origin and the supply chain of the radio equipment,

(c)the nature of the risk involved, and

(d)the nature and duration of the measures taken by the enforcing authority.

(5) In this regulation, “prescribed period” means a period which is—

(a)prescribed by the enforcing authority, and

(b)reasonable and commensurate with the nature of the risk presented by the radio equipment.

Extent Information

E42This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Enforcement action in respect of radio equipment which is in conformity, but presents a riskN.I.

62.—(1) Where, having carried out an evaluation under regulation 59 (evaluation of radio equipment presenting a risk), an enforcing authority finds that although the radio equipment is in conformity with Part 2, it presents a risk, the enforcing authority must require a relevant economic operator to take appropriate measures to—

(a)ensure that the radio equipment, when placed on the market, no longer presents a risk,

(b)withdraw the radio equipment [F349from Northern Ireland] within a prescribed period, or

(c)recall the radio equipment [F350from Northern Ireland] within a prescribed period.

(2) Where an enforcing authority is not the Secretary of State and it takes measures under paragraph (1), it must notify the Secretary of State immediately.

(3) Where the Secretary of State receives notification under paragraph (2) or takes measures under paragraph (1), the Secretary of State must notify the European Commission and the other [F351relevant states] immediately.

(4) The notifications referred to in paragraphs (2) and (3) must include details about the radio equipment and, in particular—

(a)the data necessary for the identification of the radio equipment concerned,

(b)the origin and the supply chain of the radio equipment,

(c)the nature of the risk involved, and

(d)the nature and duration of the measures taken by the enforcing authority.

(5) In this regulation, “prescribed period” means a period which is—

(a)prescribed by the enforcing authority, and

(b)reasonable and commensurate with the nature of the risk presented by the radio equipment.

Extent Information

E132This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Enforcement action in respect of formal non-complianceE+W+S

63.—(1) Where an enforcing authority makes one of the following findings relating to radio equipment, it must require a relevant economic operator to put an end to the non-compliance within such reasonable period as the authority specifies—

(a)the [F144UK] marking—

(i)has not been affixed, or

(ii)has been affixed otherwise than in accordance with regulations 39 (prohibition on improper use of [F145UK] marking) and 44 ([F145UK] marking),

(b)where the conformity assessment procedure set out in Schedule 4 (full quality assurance) is applied, the identification number of the [F146approved] body—

(i)has not been affixed, or

(ii)has been affixed otherwise than in accordance with regulation 44 ([F147UK] marking),

(c)the F148... declaration of conformity—

(i)has not been drawn up, or

(ii)has been drawn up otherwise than in accordance with regulations 10 (F148... declaration of conformity and [F149UK] marking) and 42 (F148... declaration of conformity),

(d)the technical documentation is either not available or not complete,

(e)the following information that is required to be included is absent, false or incomplete—

(i)the information specified in regulation 12(1) or (2) (identification of the radio equipment and manufacturer), or

(ii)the information specified in regulation 23(1) (information identifying importer),

(f)the information specified in regulation 13(1), (2) or (3) (instructions and information to be included with the radio equipment) is absent,

(g)the requirements set out in regulation 38 (identification of economic operators) on the identification of economic operators have not been met.

(2) Until the specified period has elapsed, the enforcing authority must not commence proceedings under these Regulations, or take any other enforcement action under these Regulations, against the relevant economic operator in respect of the non-compliance referred to in paragraph (1).

(3) Where the non-compliance referred to in paragraph (1) persists beyond the specified period, the enforcing authority must take appropriate measures to—

(a)restrict or prohibit corresponding radio equipment being made available on the market,

(b)ensure that the radio equipment is withdrawn, or

(c)ensure that the radio equipment is recalled.

(4) This regulation does not apply where radio equipment presents a risk.

Extent Information

E43This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Enforcement action in respect of formal non-complianceN.I.

63.—(1) Where an enforcing authority makes one of the following findings relating to radio equipment, it must require a relevant economic operator to put an end to the non-compliance within such reasonable period as the authority specifies—

(a)the CE marking—

(i)has not been affixed, or

(ii)has been affixed otherwise than in accordance with regulations 39 (prohibition on improper use of CE marking) and 44 (CE marking),

[F352(aa)where a notified body established in the United Kingdom has been involved in a conformity assessment procedure pursuant to regulation 41—

(i)the UK(NI) indication has not been affixed; or

(ii)the UK(NI) indication has been affixed other than in accordance with regulation 44A;]

(b)where the conformity assessment procedure set out in Schedule 4 (full quality assurance) is applied, the identification number of the notified body—

(i)has not been affixed, or

(ii)has been affixed otherwise than in accordance with regulation 44 (CE marking),

(c)the EU declaration of conformity—

(i)has not been drawn up, or

(ii)has been drawn up otherwise than in accordance with regulations 10 (EU declaration of conformity and CE marking) and 42 (EU declaration of conformity),

(d)the technical documentation is either not available or not complete,

(e)the following information that is required to be included is absent, false or incomplete—

(i)the information specified in regulation 12(1) or (2) (identification of the radio equipment and manufacturer), or

(ii)the information specified in regulation 23(1) (information identifying importer),

(f)the information specified in regulation 13(1), (2) or (3) (instructions and information to be included with the radio equipment) is absent,

(g)the requirements set out in regulation 38 (identification of economic operators) on the identification of economic operators have not been met.

(2) Until the specified period has elapsed, the enforcing authority must not commence proceedings under these Regulations, or take any other enforcement action under these Regulations, against the relevant economic operator in respect of the non-compliance referred to in paragraph (1).

(3) Where the non-compliance referred to in paragraph (1) persists beyond the specified period, the enforcing authority must take appropriate measures to—

(a)restrict or prohibit corresponding radio equipment being made available on the market,

(b)ensure that the radio equipment is withdrawn, or

(c)ensure that the radio equipment is recalled.

(4) This regulation does not apply where radio equipment presents a risk.

Extent Information

E133This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Restrictive measuresU.K.

64.  When enforcing these Regulations, an enforcing authority must comply with the requirements of Article 21 of RAMS (as amended from time to time) in relation to any measure to—

(a)prohibit or restrict radio equipment being made available on the market,

(b)withdraw radio equipment, or

(c)recall radio equipment.

OffencesU.K.

65.—(1) It is an offence for a person to contravene or fail to comply with any requirement of regulations 7 to 15, 16(4), 17 and 18, 20 to 28, 29(4), 30 to 34, 35(4).

(2) It is an offence for any person to contravene or fail to comply with any requirement of a withdrawal or recall notice served on that person by an enforcing authority under these Regulations.

PenaltiesE+W+S

66.—(1) Subject to paragraph (2), a person guilty of an offence under regulation 65 is liable on summary conviction—

(a)in England and Wales, to a fine or imprisonment for a term not exceeding 3 months or to both,

(b)in Scotland and Northern Ireland, to a fine not exceeding level 5 on the standard scale or imprisonment for a term not exceeding 3 months or to both.

(2) A person guilty of an offence under [F150regulations 11, 16, 28, 29 and 35] is liable on summary conviction—

(a)in England and Wales, to a fine,

(b)in Scotland and Northern Ireland, to a fine not exceeding level 5 on the standard scale.

Extent Information

E44This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

PenaltiesN.I.

66.—(1) Subject to [F353paragraphs (2) and (3)], a person guilty of an offence under regulation 65 is liable on summary conviction—

(a)in England and Wales, to a fine or imprisonment for a term not exceeding 3 months or to both,

(b)in Scotland and Northern Ireland, to a fine not exceeding level 5 on the standard scale or imprisonment for a term not exceeding 3 months or to both.

(2) A person guilty of an offence under [F354regulations 11, 16, 28, 29 and 35] is liable on summary conviction—

(a)in England and Wales, to a fine,

(b)in Scotland and Northern Ireland, to a fine not exceeding level 5 on the standard scale.

[F355(3) A person guilty of an offence under regulation 65(2) insofar as the requirement relates to a UK(NI) indication is liable on summary conviction to a fine not exceeding level 5 on the standard scale.]

Extent Information

E134This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Defence of due diligenceU.K.

67.—(1) Subject to paragraphs (2) and (4), in proceedings for an offence under regulation 65 (offences), it is a defence for a person (“P”) to show that P took all reasonable steps and exercised all due diligence to avoid committing the offence.

(2) P may not rely on a defence under paragraph (1) which involves a third party allegation unless P has—

(a)served a notice in accordance with paragraph (3), or

(b)obtained the leave of the court.

(3) The notice must—

(a)give any information in P's possession which identifies or assists in identifying the person who—

(i)committed the act or default, or

(ii)supplied the information on which P relied.

(b)be served on the person bringing the proceedings not less than 7 clear days before—

(i)in England, Wales and Northern Ireland, the hearing of the proceedings,

(ii)in Scotland, the trial diet.

(4) P may not rely on a defence under paragraph (1) which involves an allegation that the commission of the offence was due to reliance on information supplied by another person unless it was reasonable for P to have relied upon the information, having regard in particular—

(a)to the steps that P took, and those which might reasonably have been taken, for the purpose of verifying the information, and

(b)to whether P had any reason to disbelieve the information.

(5) In this regulation, “third party allegation” means an allegation that the commission of the offence was due—

(a)to the act or default of another person, or

(b)to reliance on information supplied by another person.

Liability of persons other than principal offenderU.K.

68.—(1) Where the commission of an offence by one person (“A”) under regulation 65 (offences) is due to anything which another person (“B”) did or failed to do in the course of business, B is guilty of the offence and may be proceeded against and punished, whether or not proceedings are taken against A.

(2) Where a body corporate commits an offence, a relevant person is also guilty of the offence where the body corporate's offence was committed—

(a)with the consent or connivance of the relevant person, or

(b)as a result of the negligence of the relevant person.

(3) In paragraph (2), “relevant person” means—

(a)a director, manager, secretary or other similar officer of the body corporate,

(b)in relation to a body corporate managed by its members, a member of that body corporate performing managerial functions,

(c)in relation to a Scottish partnership, a partner, or

(d)a person purporting to act as a person described in sub-paragraphs (a), (b) or (c).

Time limit for prosecution of offencesU.K.

69.—(1) Subject to paragraph (4), in England and Wales an information relating to an offence under regulation 65 (offences) that is triable by a magistrates' court may be so tried if it is laid within 12 months after the date on which evidence sufficient in the opinion of the prosecutor to justify the proceedings comes to the knowledge of the prosecutor.

(2) Subject to paragraph (4), in Scotland—

(a)summary proceedings for an offence under regulation 65 may be commenced before the end of 12 months after the date on which evidence sufficient in the Lord Advocate's opinion to justify the proceedings came to the Lord Advocate's knowledge,

(b)section 136(3) of the Criminal Procedure (Scotland) Act 1995 M10 (time limit for certain offences) applies for the purpose of this paragraph as it applies for the purpose of that section.

(3) Subject to paragraph (4), in Northern Ireland summary proceedings for an offence under regulation 65 may be instituted within 12 months after the date on which evidence sufficient in the opinion of the prosecutor to justify proceedings comes to the knowledge of the prosecutor.

(4) No proceedings may be brought more than 3 years after the commission of the offence.

(5) For the purposes of this regulation a certificate of the prosecutor (or in Scotland, the Lord Advocate) as to the date on which the evidence referred to in paragraphs (1), (2) or (3) came to light, is conclusive evidence.

Marginal Citations

Service of documentsU.K.

70.—(1) Any document required or authorised by these Regulations to be served on a person may be served by—

(a)delivering it to that person in person,

(b)leaving it at that person's proper address, or

(c)sending it by post or electronic means to that person's proper address.

(2) In the case of a body corporate, a document may be served on a director of that body.

(3) In the case of a partnership, a document may be served on a partner or a person having control or management of the partnership business.

(4) For the purposes of this regulation, “proper address” means—

(a)in the case of a body corporate or its director—

(i)the registered or principal office of that body, or

(ii)the email address of the secretary or clerk of that body,

(b)in the case of a partnership, a partner or person having control or management of the partnership business—

(i)the principal office of the partnership, or

(ii)the email address of a partner or person having that control or management,

(c)in any other case, a person's last known address, which includes an email address.

(5) If a person to be served with a document has specified an address in the United Kingdom (other than that person's proper address) at which that person or someone on that person's behalf will accept service, that address must also be treated as that person's proper address.

(6) In this regulation, “partnership” includes a Scottish partnership.

Recovery of expenses of enforcementU.K.

71.—(1) This regulation applies where a person commits an offence under regulation 65 (offences).

(2) The court may (in addition to any other order it may make as to costs or expenses) order the person to reimburse the enforcing authority for any expenditure which the enforcing authority has incurred in investigating the offence.

Action by enforcing authorityU.K.

72.—(1) An enforcing authority may itself take action which an economic operator could have been required to take by a notice served under these Regulations where the conditions for serving such a notice are met and either—

(a)the enforcing authority has been unable to identify any economic operator on whom to serve such a notice, or

(b)the economic operator on whom such a notice has been served has failed to comply with it.

(2) If the enforcing authority has taken action as a result of the condition in paragraph (1)(b) being met, the authority may recover from the economic operator, as a civil debt, any costs or expenses reasonably incurred by the enforcing authority in taking the action.

(3) A civil debt recoverable under paragraph (2) may be recovered summarily—

(a)in England and Wales by way of a complaint pursuant to section 58 of the Magistrates' Courts Act 1980 M11,

(b)in Northern Ireland in proceedings under article 62 of the Magistrates' Court (Northern Ireland) Order 1981 M12.

Marginal Citations

M111980 c. 43. Section 58 was amended by paragraph 40 of Schedule 10 to the Crime and Courts Act 2013 (c. 22).

M12S.R. (NI) 1981 No 1675.

Appeals against noticesU.K.

73.—(1) An application for an order to vary or set aside the terms of a notice served under these Regulations may be made—

(a)by the economic operator on whom the notice has been served,

(b)by a person having an interest in the radio equipment in respect of which the notice has been served, unless the notice is a recall notice.

(2) An application must be made before the end of the period of 21 days beginning with the day on which the notice was served.

(3) The appropriate court may only make an order setting aside a notice served under these Regulations if satisfied—

(a)that the requirements of these Regulations and of RAMS (in its application to radio equipment) have been complied with in respect of the radio equipment to which the notice relates, or

(b)that the enforcing authority failed to comply with regulation 58 (exercise of enforcement powers) when serving the notice.

(4) On an application to vary the terms of a notice served under these Regulations, the appropriate court may vary the terms of the notice as it considers appropriate.

(5) In this regulation—

(a)the “appropriate court” is to be determined in accordance with regulation 74 (appropriate court for appeals against notices),

(b)“notice” means any notice served in accordance with Schedule 10.

Appropriate court for appeals against noticesU.K.

74.—(1) In England and Wales or Northern Ireland, the appropriate court for the purposes of regulation 73 (appeals against notices) is—

(a)the court in which proceedings have been brought in relation to the radio equipment for an offence under regulation 65 (offences),

(b)in any other case, a magistrates' court.

(2) In Scotland, the appropriate court for the purposes of regulation 73 is the sheriff of a sheriffdom in which the person making the appeal resides or has a registered or principal office.

(3) A person aggrieved by an order made by a magistrates' court in England and Wales or Northern Ireland pursuant to an application under regulation 73, or by a decision of such a court not to make such an order, may appeal against that order or decision—

(a)in England and Wales, to the Crown Court,

(b)in Northern Ireland, to the county court.

CompensationU.K.

75.—(1) Where an enforcing authority serves a relevant notice in respect of radio equipment, the enforcing authority is liable to pay compensation to a person having an interest in the radio equipment for any loss or damage suffered by reason of the notice if both of the conditions in paragraph (2) are met.

(2) The conditions are that—

(a)the radio equipment in respect of which the relevant notice was served neither—

(i)presents a risk, nor

(ii)contravenes any requirements of these Regulations, and

(b)the exercise of the power to serve the relevant notice was not attributable to neglect or default by a relevant economic operator.

(3) In this regulation, “relevant notice” means a suspension, withdrawal or recall notice served in accordance with these Regulations.

PART 6U.K.Miscellaneous

ReviewE+W+S

76.—(1) The Secretary of State must from time to time—

(a)carry out a review of the regulatory provision contained in these Regulations, and

(b)publish a report setting out the conclusions of the review.

(2) The first report must be published before the end of the period of 5 years beginning with the commencement date.

(3) Subsequent reports must be published at intervals not exceeding 5 years.

(4) Section 30(3) of the Small Business, Enterprise and Employment Act 2015 M13 requires that a review carried out under this regulation must, so far as is reasonable, have regard to how the Directive is implemented in other Member States.

(5) Section 30(4) of the Small Business, Enterprise and Employment Act 2015 requires that a report published under this regulation must, in particular—

(a)set out the objectives intended to be achieved by the regulatory provision referred to in paragraph 1(a),

(b)assess the extent to which those objectives are achieved,

(c)assess whether those objectives remain appropriate, and

(d)if those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision.

(6) In this regulation, “regulatory provision” has the same meaning as in sections 28 to 32 of the Small Business, Enterprise and Employment Act 2015 (see section 32 of that Act).

Extent Information

E45This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Marginal Citations

M132015 c.26. Section 30(3) was amended by the Enterprise Act 2016 (c.12), section 19.

ReviewN.I.

76.—(1) The Secretary of State must from time to time—

(a)carry out a review of the regulatory provision contained in these Regulations, and

(b)publish a report setting out the conclusions of the review.

(2) The first report must be published before the end of the period of 5 years beginning with the commencement date.

(3) Subsequent reports must be published at intervals not exceeding 5 years.

(4) Section 30(3) of the Small Business, Enterprise and Employment Act 2015 F356 requires that a review carried out under this regulation must, so far as is reasonable, have regard to how the Directive is implemented in other [F357relevant states].

(5) Section 30(4) of the Small Business, Enterprise and Employment Act 2015 requires that a report published under this regulation must, in particular—

(a)set out the objectives intended to be achieved by the regulatory provision referred to in paragraph 1(a),

(b)assess the extent to which those objectives are achieved,

(c)assess whether those objectives remain appropriate, and

(d)if those objectives remain appropriate, assess the extent to which they could be achieved in another way which involves less onerous regulatory provision.

(6) In this regulation, “regulatory provision” has the same meaning as in sections 28 to 32 of the Small Business, Enterprise and Employment Act 2015 (see section 32 of that Act).

Extent Information

E135This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F3562015 c.26. Section 30(3) was amended by the Enterprise Act 2016 (c.12), section 19.

[F151Transitional provision in relation to EU ExitE+W+S

76A.—(1) In this regulation—

“pre-exit period” means the period beginning with the commencement date and ending immediately before IP completion day;

“product” means radio equipment to which these Regulations apply.

(2) Subject to paragraph (3), where a product was made available on the market during the pre-exit period, despite the amendments made by Schedule 29 of the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, any obligation to which a person was subject under these Regulations as they had effect immediately before IP completion day, continues to have effect as it did immediately before IP completion day, in relation to that product.

(3) Paragraph (2) does not apply to—

(a)any obligation of any enforcing authority to inform the European Commission or the Member States of any matter; or

(b)any obligation to take action outside of the market in respect of that product.

F152(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F152(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F152(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

Textual Amendments

Transitional provisionE+W+S

77.  Nothing in these Regulations prevents the making available on the market of radio equipment which—

(a)is in conformity with the requirements of [F153the Radio Equipment and Telecommunications Terminal Equipment Regulations 2000], and

(b)is placed on the market on or before the commencement date.

Extent Information

E46This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Transitional provisionN.I.

77.  Nothing in these Regulations prevents the making available on the market of radio equipment which—

(a)is in conformity with the requirements of Directive 1999/5/EC of the European Parliament and the Council on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity F358, and

(b)is placed on the market on or before the commencement date.

Extent Information

E136This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F358OJ L 91, 7.4.1999, p.10.

Revocations and savingsE+W+S

78.—(1) Subject to paragraph (2), the Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 M14 are revoked.

[F154(2) The Regulations referred to in paragraph (1) continue to apply, as if they had not been revoked, to any equipment placed on the market in accordance with those Regulations before the commencement date, subject to the modifications made in paragraph (2A).]

[F155(2A) The modifications referred to in paragraph (2) are as follows—

(a)references to the Community are to be read as including the United Kingdom;

(b)except where “Member State” first appears in regulation 14 (notified bodies), references to Member State are to be read as including the United Kingdom;

(c)the references to European Union and EEA State in regulation 14 are both to be read as including the United Kingdom;

(d)regulation 18A (duty of enforcement authority to inform Secretary of State of action taken), is to be read without the words “, with a view to this information being passed by her to the Commission.”;

(e)Schedule 5 applies as if paragraph 6 were omitted.]

(3) In relation to radio equipment placed on the market before the commencement date, the amendments in regulations 79 and 80 do not apply.

Extent Information

E47This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Marginal Citations

M14S.I. 2000/730; amended by S.I. 2003/1903, S.I. 2003/3144, S.I. 2005/281, S.I. 2015/1630 and S.I. 2016/1101.

Revocations and savingsN.I.

78.—(1) Subject to paragraph (2), the Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 F359 are revoked.

(2) The Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 continue to apply to any equipment placed on the market in accordance with those Regulations before the commencement date.

(3) In relation to radio equipment placed on the market before the commencement date, the amendments in regulations 79 and 80 do not apply.

Extent Information

E137This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F359S.I. 2000/730; amended by S.I. 2003/1903, S.I. 2003/3144, S.I. 2005/281, S.I. 2015/1630 and S.I. 2016/1101.

Consequential and other amendmentsU.K.

79.—(1) The Enterprise Act 2002 (Part 9 Restrictions on Disclosure of Information) (Specification) Order 2004 M15 is amended as follows.

(2) In Schedule 1, for “Radio Equipment and Telecommunications Terminal Equipment Regulations 2000” substitute “ Radio Equipment Regulations 2017 ”.

Marginal Citations

M15S.I. 2004/693 to which there are amendments not relevant to these Regulations.

80.—(1) The Consumer Rights Act 2015 M16 is amended as follows.

(2) In paragraph 10 of Schedule 5—

(a)omit the entry “paragraph 1(1)(b) or (2)(b) or 2 of Schedule 9 to the Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 (SI 2000/730)”, and

(b)at the appropriate place insert—

“regulation 56(1)(a)(ii) or (b)(ii) or (2) of the Radio Equipment Regulations 2017 (S.I. 2017/1206)”.

Marginal Citations

81.—(1) The Electromagnetic Compatibility Regulations 2016 M17 are amended as follows.

(2) In regulation 2 (interpretation)—

(a)in paragraph (1), omit the definition of “notified body”, and

(b)after paragraph (4), insert—

“(5) In these Regulations (except Part 4 (notification of conformity assessment bodies) and Schedules 5 (requirements for notified bodies) and 6 (operational obligations of notified bodies)), “notified body” means—

(a)a notified body within the meaning set out in regulation 43 (notified bodies), or

(b)a notified body under the laws of any other Member State which implements the Directive.”.

(3) In regulation 52 (designation of enforcing authorities) omit paragraph (4).

Marginal Citations

82.—(1) The Pressure Equipment (Safety) Regulations 2016 M18 are amended as follows.

(2) In regulation 2 (interpretation)—

(a)in paragraph (1)—

(i)for the definition of “authorised representative” substitute—

““authorised representative” means a person established within the EU appointed in accordance with regulation 19(1) (manufacturer's authorised representative);”,

(ii)omit the definition of “notified body”, and

(b)after paragraph (6), insert—

“(7) In these Regulations (except Part 4 (notification of conformity assessment bodies) and Schedules 4 (notified body requirements) and 6 (operational obligations of notified bodies, recognised third party organisations and user inspectorates)), “notified body” means—

(a)a notified body within the meaning set out in regulation 51 (notified bodies), or

(b)a notified body under the laws of any other Member State which implement the Directive.”.

Marginal Citations

83.—(1) The Simple Pressure Vessels (Safety) Regulations 2016 M19 are amended as follows.

(2) In regulation 2 (interpretation)—

(a)in paragraph (4), omit the definition of “notified body”, and

(b)after paragraph (6), insert—

“(7) In these Regulations (except Part 4 (notification of conformity assessment bodies) and Schedule 4 (notified bodies), “notified body” means—

(a)a notified body within the meaning set out in regulation 45 (notified bodies), or

(b)a notified body under the laws of any other Member State which implements the Directive.”.

Marginal Citations

84.—(1) The Electrical Equipment (Safety) Regulations 2016 M20 are amended as follows.

(2) In paragraph (1) of regulation 2, for the definition of “authorised representative” substitute—

““authorised representative” means a person established within the EU appointed in accordance with regulation 14 (manufacturer's authorised representatives);”.

(3) In paragraph (3) of regulation 3, for “apparatus covered by the Radio Equipment and Telecommunications Terminal Equipment Regulations 2000” substitute “ equipment covered by the Radio Equipment Regulations 2017 ”.

(4) In regulation 29 (duty to take action in respect of electrical equipment placed on the market which is not considered to be in conformity)—

(a)in the title of the regulation, for “placed” substitute “ made available ”,

(b)in paragraph (1), for “placed” substitute “ made available ”.

Marginal Citations

85.—(1) The Recreational Craft Regulations 2017 M21 are amended as follows.

(2) In regulation 29 (duty not to place a product on the market where the distributor suspects that it is not in conformity)—

(a)in the title of the regulation, for “place a product” substitute “ make a product available ”,

(b)in paragraph (1), for “place the product” substitute “ make the product available ”.

Marginal Citations

Margot James

Minister for Small Business, Consumer and corporate Responsibility

Department for Business, Energy & Industrial Strategy

Regulation 3(2)(b)

SCHEDULE 1U.K.Radio equipment outside the scope of these Regulations

1.—(1) Radio equipment used by radio amateurs within the meaning of Article 1, definition 56, of the International Telecommunications Union (ITU) Radio Regulations M22, unless the equipment is made available on the market.U.K.

(2) The following must be regarded as not being made available on the market—

(a)radio kits for assembly and use by radio amateurs,

(b)radio equipment modified by and for the use of radio amateurs, and

(c)equipment constructed by individual radio amateurs for experimental and scientific purposes related to amateur radio.

Marginal Citations

M22See http://www.itu.int/pub/R-REG-RR.

[F1562.  Marine equipment falling within the Merchant Shipping (Marine Equipment) Regulations 2016.]E+W+S

Extent Information

E48This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

2.  Marine equipment falling within the scope of Council Directive 96/98/EC on marine equipment F360.N.I.

Extent Information

E138This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F360OJ L 46, 17.2.1997, p.25.

3.  Airborne products, parts and appliances falling within the scope of Article 3 of Regulation (EC) No 216/2008 of the European Parliament and of the Council on common rules in the field of civil aviation and establishing a European Aviation Safety Agency M23.U.K.

Marginal Citations

M23OJ L 79, 19.3.2008, p.1.

4.  Custom-built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.U.K.

Regulation 41(4)(a)

SCHEDULE 2U.K.Conformity assessment module A

Internal production controlU.K.

1.  Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2, 3 and 4 and ensures and declares on his sole responsibility that the radio equipment concerned satisfies the essential requirements.U.K.

Technical documentationU.K.

2.  The manufacturer must establish the technical documentation in accordance with regulation 45 (technical documentation).

ManufacturingU.K.

3.  The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured radio equipment with the technical documentation referred to in paragraph 2 and with the essential requirements.

[F157UK] marking and F158... declaration of conformityE+W+S

4.—(1) The manufacturer must affix the [F159UK] marking in accordance with regulations 39 (prohibition on improper use of [F159UK] marking) and 44 ([F159UK] marking) to each item of radio equipment that satisfies the applicable requirements of these Regulations.

(2) The manufacturer must draw up a written F160... declaration of conformity for each radio equipment type and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market. The F160... declaration of conformity must identify the radio equipment for which it has been drawn up.

(3) A copy of the F161... declaration of conformity must be made available to the relevant authorities upon request.

Extent Information

E49This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

CE marking and EU declaration of conformityN.I.

4.—(1) The manufacturer must affix the CE marking in accordance with regulations 39 (prohibition on improper use of CE marking) and 44 (CE marking) to each item of radio equipment that satisfies the applicable requirements of these Regulations.

(2) The manufacturer must draw up a written EU declaration of conformity for each radio equipment type and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market. The EU declaration of conformity must identify the radio equipment for which it has been drawn up.

(3) A copy of the EU declaration of conformity must be made available to the relevant authorities upon request.

Extent Information

E139This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Authorised representativesU.K.

5.  The manufacturer's obligations set out in paragraph 4 may be fulfilled by the manufacturer's authorised representative, on the manufacturer's behalf and under the manufacturer's responsibility, provided that they are specified in the mandate.

Regulation 41(4)(b)

SCHEDULE 3U.K.Conformity assessment modules B and C

[F162EU-type] [F162Type] examination and conformity to type based on internal production controlU.K.

Textual Amendments

When reference is made to this Schedule, the conformity assessment procedure must follow Modules B ([F162EU-type] [F162Type] examination) and C (Conformity to type based on internal production control) of this Schedule.

Module BU.K.

[F162Type] examinationE+W+S

1.  [F163Type] examination is the part of a conformity assessment procedure in which a notified body examines the technical design of the radio equipment and verifies and attests that the technical design of the radio equipment meets the essential requirements.

Extent Information

E50This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

EU-type examinationN.I.

1.  EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of the radio equipment and verifies and attests that the technical design of the radio equipment meets the essential requirements.

Extent Information

E140This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

2.  [F164Type] examination must be carried out by assessment of the adequacy of the technical design of the radio equipment through examination of the technical documentation and supporting evidence referred to in paragraph 3, without examination of a specimen (design type).E+W+S

Extent Information

E51This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

2.  EU-type examination must be carried out by assessment of the adequacy of the technical design of the radio equipment through examination of the technical documentation and supporting evidence referred to in paragraph 3, without examination of a specimen (design type).N.I.

Extent Information

E141This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

3.—(1) The manufacturer must lodge an application for [F165Type] examination with a single [F166approved] body of the manufacturer's choice.E+W+S

(2) The application must include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, the representative's name and address as well;

(b)a written declaration that the same application has not been lodged with any other [F167approved] body;

(c)the technical documentation. The technical documentation shall make it possible to assess the radio equipment's conformity with the applicable requirements of these Regulations and must include an adequate analysis and assessment of the risk(s). The technical documentation must specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the radio equipment. The technical documentation must contain, wherever applicable, the elements set out in Schedule 5 (contents of technical documentation);

(d)the supporting evidence for the adequacy of the technical design solution. That supporting evidence must mention any documents that have been used, in particular where the relevant [F168designated] standards have not been applied or have not been fully applied. The supporting evidence must include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer's behalf and under the manufacturer's responsibility.

Extent Information

E52This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

3.—(1) The manufacturer must lodge an application for EU-type examination with a single notified body of the manufacturer's choice.N.I.

(2) The application must include:

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, the representative's name and address as well;

(b)a written declaration that the same application has not been lodged with any other notified body;

(c)the technical documentation. The technical documentation shall make it possible to assess the radio equipment's conformity with the applicable requirements of these Regulations and must include an adequate analysis and assessment of the risk(s). The technical documentation must specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the radio equipment. The technical documentation must contain, wherever applicable, the elements set out in Schedule 5 (contents of technical documentation);

(d)the supporting evidence for the adequacy of the technical design solution. That supporting evidence must mention any documents that have been used, in particular where the relevant harmonised standards have not been applied or have not been fully applied. The supporting evidence must include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on the manufacturer's behalf and under the manufacturer's responsibility.

Extent Information

E142This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

4.  The [F169approved] body must examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the radio equipment.E+W+S

Extent Information

E53This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

4.  The notified body must examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the radio equipment.N.I.

Extent Information

E143This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

5.  The [F170approved] body must draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to its obligations as provided in paragraph 8, the [F170approved] body must release the content of that report, in full or in part, only with the agreement of the manufacturer.E+W+S

Extent Information

E54This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

5.  The notified body must draw up an evaluation report that records the activities undertaken in accordance with paragraph 4 and their outcomes. Without prejudice to its obligations as provided in paragraph 8, the notified body must release the content of that report, in full or in part, only with the agreement of the manufacturer.N.I.

Extent Information

E144This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

6.—(1) Where the type meets the requirements of these Regulations that apply to the radio equipment concerned, the [F171approved] body must issue [F172a Type] examination certificate to the manufacturer. That certificate must contain—E+W+S

(a)the name and address of the manufacturer,

(b)the conclusions of the examination,

(c)the aspects of the essential requirements covered by the examination,

(d)the conditions (if any) for its validity, and

(e)the necessary data for identification of the assessed type.

(2) The [F173Type] examination certificate may have one or more annexes attached.

(3) The [F174Type] examination certificate and its annexes must contain all relevant information to allow the conformity of manufactured radio equipment with the examined type to be evaluated and to allow for in-service control.

(4) Where the type does not satisfy the applicable requirements of these Regulations, the [F175approved] body must refuse to issue [F176a Type] examination certificate and must inform the applicant accordingly, giving detailed reasons for its refusal.

Extent Information

E55This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

6.—(1) Where the type meets the requirements of these Regulations that apply to the radio equipment concerned, the notified body must issue an EU-type examination certificate to the manufacturer. That certificate must contain—N.I.

(a)the name and address of the manufacturer,

(b)the conclusions of the examination,

(c)the aspects of the essential requirements covered by the examination,

(d)the conditions (if any) for its validity, and

(e)the necessary data for identification of the assessed type.

(2) The EU-type examination certificate may have one or more annexes attached.

(3) The EU-type examination certificate and its annexes must contain all relevant information to allow the conformity of manufactured radio equipment with the examined type to be evaluated and to allow for in-service control.

(4) Where the type does not satisfy the applicable requirements of these Regulations, the notified body must refuse to issue an EU-type examination certificate and must inform the applicant accordingly, giving detailed reasons for its refusal.

Extent Information

E145This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

7.—(1) The [F177approved] body must keep itself appraised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these Regulations, and must determine whether such changes require further investigation. If so, the [F177approved] body must inform the manufacturer accordingly.E+W+S

(2) The manufacturer must inform the [F177approved] body that holds the technical documentation relating to the [F178Type] examination certificate of all modifications to the approved type that may affect the conformity of the radio equipment with the essential requirements of these Regulations or the conditions for validity of that certificate. Such modifications require additional approval in the form of an addition to the original [F178Type] examination certificate.

Extent Information

E56This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

7.—(1) The notified body must keep itself appraised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the applicable requirements of these Regulations, and must determine whether such changes require further investigation. If so, the notified body must inform the manufacturer accordingly.N.I.

(2) The manufacturer must inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the radio equipment with the essential requirements of these Regulations or the conditions for validity of that certificate. Such modifications require additional approval in the form of an addition to the original EU-type examination certificate.

Extent Information

E146This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

8.—(1) Each [F179approved] body must inform [F180the Secretary of State] concerning the [F181Type] examination certificates and/or any additions thereto which it has issued or withdrawn, and must, periodically or upon request, make available to [F180the Secretary of State] the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.E+W+S

(2) Each [F179approved] body must inform the other [F179approved] bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.

(3) Each [F179approved] body must inform the [F182Secretary of State and the other approved bodies] of [F183Type] examination certificates it has issued and/or additions thereto in those cases where [F184designated] standards F185... have not been applied or not been fully applied. The [F186Secretary of State] and the other [F179approved] bodies may, on request, obtain a copy of the [F183Type] examination certificates and/or additions thereto. On request, the [F187Secretary of State] may obtain a copy of the technical documentation and the results of the examinations carried out by the [F179approved] body. The [F179approved] body must keep a copy of the [F183Type] examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer for 10 years after the radio equipment has been assessed or until the expiry of the validity of that certificate.

Extent Information

E57This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

8.—(1) Each notified body must inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and must, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted.N.I.

(2) Each notified body must inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning such certificates and/or additions thereto which it has issued.

(3) Each notified body must inform the [F361relevant states] of EU-type examination certificates it has issued and/or additions thereto in those cases where harmonised standards the references of which have been published in the Official Journal have not been applied or not been fully applied. The [F361relevant states], the European Commission and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the [F361relevant states] and the European Commission may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body must keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer for 10 years after the radio equipment has been assessed or until the expiry of the validity of that certificate.

Extent Information

E147This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

9.  The manufacturer must keep a copy of the [F188Type] examination certificate, its annexes and additions together with the technical documentation at the disposal of the [F189enforcing] authorities for 10 years after the radio equipment has been placed on the market.E+W+S

Extent Information

E58This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

9.  The manufacturer must keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market.N.I.

Extent Information

E148This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

10.  The manufacturer's authorised representative may lodge the application referred to in paragraph 3 and fulfil the obligations set out in paragraphs 7 and 9, provided that they are specified in the mandate.U.K.

Module CU.K.

Conformity to type based on internal production controlE+W+S

11.  Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 3, and ensures and declares that the radio equipment concerned is in conformity with the type described in the [F190Type] examination certificate and satisfies the requirements of these Regulations that apply to it.

Extent Information

E59This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Conformity to type based on internal production controlN.I.

11.  Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 3, and ensures and declares that the radio equipment concerned is in conformity with the type described in the EU-type examination certificate and satisfies the requirements of these Regulations that apply to it.

Extent Information

E149This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

ManufacturingE+W+S

12.  The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured radio equipment with the approved type described in the [F191Type] examination certificate and with the requirements of these Regulations that apply to it.

Extent Information

E60This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

ManufacturingN.I.

12.  The manufacturer must take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured radio equipment with the approved type described in the EU-type examination certificate and with the requirements of these Regulations that apply to it.

Extent Information

E150This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F192UK] marking and F193... declaration of conformityE+W+S

13.—(1) The manufacturer must affix the [F194UK] marking in accordance with regulations 39 (prohibition on improper use of [F194UK] marking) and 44 ([F194UK] marking) to each item of radio equipment that is in conformity with the type described in the [F195Type] examination certificate and satisfies the applicable requirements of these Regulations.

(2) The manufacturer must draw up a written F196... declaration of conformity for each radio equipment type and keep it at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market. The F196...declaration of conformity must identify the radio equipment type for which it has been drawn up.

(3) A copy of the F197... declaration of conformity must be made available to the relevant authorities upon request.

Extent Information

E61This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

CE marking and EU declaration of conformityN.I.

13.—(1) The manufacturer must affix the CE marking in accordance with regulations 39 (prohibition on improper use of CE marking) and 44 (CE marking) to each item of radio equipment that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of these Regulations.

(2) The manufacturer must draw up a written EU declaration of conformity for each radio equipment type and keep it at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market. The EU declaration of conformity must identify the radio equipment type for which it has been drawn up.

(3) A copy of the EU declaration of conformity must be made available to the relevant authorities upon request.

Extent Information

E151This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Authorised representativeU.K.

14.  The manufacturer's obligations set out in paragraph 3 may be fulfilled by the manufacturer's authorised representative, on the manufacturer's behalf and under the manufacturer's responsibility, provided that they are specified in the mandate.

Regulation 41(4)(c)

SCHEDULE 4U.K.Conformity assessment module H

Conformity based on full quality assuranceU.K.

1.  Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in paragraphs 2 and 5 and ensures and declares the manufacturer's sole responsibility that the radio equipment concerned satisfies the requirements of these Regulations that apply to it.

ManufacturingU.K.

2.  The manufacturer must operate an approved quality system for design, manufacture, final radio equipment inspection and testing of the radio equipment concerned as specified in paragraph 3 and must be subject to surveillance as specified in paragraph 4.

Quality systemE+W+S

3.—(1) The manufacturer must lodge an application for assessment of the manufacturer's quality system with the [F198approved] body of the manufacturer's choice, for the radio equipment concerned. The application must include—

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, the representative's name and address as well,

(b)the technical documentation for each radio equipment type intended to be manufactured. The technical documentation must contain, wherever applicable, the elements set out in Schedule 5 (contents of technical documentation),

(c)the documentation concerning the quality system, and

(d)a written declaration that the same application has not been lodged with any other [F199approved] body.

(2) The quality system must ensure compliance of the radio equipment with the requirements of these Regulations that apply to it. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. That quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records. It must, in particular, contain an adequate description of—

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality;

(b)the technical design specifications, including standards, that will be applied and, where the relevant [F200designated] standards will not be applied in full, the means that will be used to ensure that the essential requirements of these Regulations that apply to the radio equipment will be met;

(c)the design control and design verification techniques, processes and systematic actions that will be used when designing radio equipment pertaining to the radio equipment type covered;

(d)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

(e)the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;

(f)the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc.;

(g)the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.

(3) The [F201approved] body must—

(a)assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3(2), and

(b)presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant [F202designated] standard.

(4) In addition to experience in quality management systems, the auditing team must—

(a)have at least one member experienced as an assessor in the relevant radio equipment field and radio equipment technology concerned, and knowledge of the applicable requirements of these Regulations, and

(b)review the technical documentation referred to in paragraph 3(1)(b) to verify the manufacturer's ability to identify the applicable requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the radio equipment with those requirements.

(5) The audit must include an assessment visit to the manufacturer's premises.

(6) The manufacturer or the manufacturer's authorised representative must be notified of the decision.

(7) The notification must contain the conclusions of the audit and the reasoned assessment decision.

(8) The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

(9) The manufacturer must keep the [F203approved] body that has approved the quality system informed of any intended change to the quality system. The [F203approved] body must evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 3(2) or whether a reassessment is necessary. The [F203approved] body must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the reasoned assessment decision.

Extent Information

E62This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Quality systemN.I.

3.—(1) The manufacturer must lodge an application for assessment of the manufacturer's quality system with the notified body of the manufacturer's choice, for the radio equipment concerned. The application must include—

(a)the name and address of the manufacturer and, if the application is lodged by the authorised representative, the representative's name and address as well,

(b)the technical documentation for each radio equipment type intended to be manufactured. The technical documentation must contain, wherever applicable, the elements set out in Schedule 5 (contents of technical documentation),

(c)the documentation concerning the quality system, and

(d)a written declaration that the same application has not been lodged with any other notified body.

(2) The quality system must ensure compliance of the radio equipment with the requirements of these Regulations that apply to it. All the elements, requirements and provisions adopted by the manufacturer must be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. That quality system documentation must permit a consistent interpretation of the quality programmes, plans, manuals and records. It must, in particular, contain an adequate description of—

(a)the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality;

(b)the technical design specifications, including standards, that will be applied and, where the relevant harmonised standards will not be applied in full, the means that will be used to ensure that the essential requirements of these Regulations that apply to the radio equipment will be met;

(c)the design control and design verification techniques, processes and systematic actions that will be used when designing radio equipment pertaining to the radio equipment type covered;

(d)the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

(e)the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;

(f)the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc.;

(g)the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.

(3) The notified body must—

(a)assess the quality system to determine whether it satisfies the requirements referred to in paragraph 3(2), and

(b)presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

(4) In addition to experience in quality management systems, the auditing team must—

(a)have at least one member experienced as an assessor in the relevant radio equipment field and radio equipment technology concerned, and knowledge of the applicable requirements of these Regulations, and

(b)review the technical documentation referred to in paragraph 3(1)(b) to verify the manufacturer's ability to identify the applicable requirements of these Regulations and to carry out the necessary examinations with a view to ensuring compliance of the radio equipment with those requirements.

(5) The audit must include an assessment visit to the manufacturer's premises.

(6) The manufacturer or the manufacturer's authorised representative must be notified of the decision.

(7) The notification must contain the conclusions of the audit and the reasoned assessment decision.

(8) The manufacturer must undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

(9) The manufacturer must keep the notified body that has approved the quality system informed of any intended change to the quality system. The notified body must evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in paragraph 3(2) or whether a reassessment is necessary. The notified body must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the reasoned assessment decision.

Extent Information

E152This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Surveillance under the responsibility of the [F204approved] bodyE+W+S

4.—(1) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

(2) The manufacturer must, for assessment purposes, allow the [F205approved] body access to the design, manufacture, inspection, testing and storage sites, and must provide it with all necessary information, in particular—

(a)the quality system documentation;

(b)the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc;

(c)the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc.

(3) The [F206approved] body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and must provide the manufacturer with an audit report.

(4) In addition, the [F207approved] body may pay unexpected visits to the manufacturer. During such visits, the [F207approved] body may, if necessary, carry out radio equipment tests, or have them carried out, in order to check the proper functioning of the quality system. It must provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

Extent Information

E63This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

Surveillance under the responsibility of the notified bodyN.I.

4.—(1) The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

(2) The manufacturer must, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and must provide it with all necessary information, in particular—

(a)the quality system documentation;

(b)the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc;

(c)the quality records as provided for by the manufacturing part of the quality system, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc.

(3) The notified body must carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and must provide the manufacturer with an audit report.

(4) In addition, the notified body may pay unexpected visits to the manufacturer. During such visits, the notified body may, if necessary, carry out radio equipment tests, or have them carried out, in order to check the proper functioning of the quality system. It must provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

Extent Information

E153This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F208UK] marking and F209... declaration of conformityE+W+S

5.—(1) The manufacturer must affix the [F210UK] marking in accordance with regulations 39 (prohibition on improper use of [F210UK] marking) and 44 ([F210UK] marking) and, under the responsibility of the [F211approved] body referred to in paragraph 3(1), the latter's identification number to each item of radio equipment that satisfies the requirements of these Regulations.

(2) The manufacturer must draw up a written F212... declaration of conformity for each radio equipment type and keep it at the disposal of the [F213enforcing] authorities for 10 years after the radio equipment has been placed on the market. The F212... declaration of conformity must identify the radio equipment type for which it has been drawn up. A copy of the F212... declaration of conformity must be made available to the [F213enforcing] authorities upon request.

Extent Information

E64This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

CE marking and EU declaration of conformityN.I.

5.—(1) The manufacturer must affix the CE marking in accordance with regulations 39 (prohibition on improper use of CE marking) and 44 (CE marking) and, under the responsibility of the notified body referred to in paragraph 3(1), the latter's identification number to each item of radio equipment that satisfies the requirements of these Regulations.

(2) The manufacturer must draw up a written EU declaration of conformity for each radio equipment type and keep it at the disposal of the national authorities for 10 years after the radio equipment has been placed on the market. The EU declaration of conformity must identify the radio equipment type for which it has been drawn up. A copy of the EU declaration of conformity must be made available to the relevant authorities upon request.

Extent Information

E154This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

6.  The manufacturer must, for a period ending 10 years after the radio equipment has been placed on the market, keep at the disposal of the [F214enforcing] authorities—E+W+S

(a)the technical documentation referred to in paragraph 3(1);

(b)the documentation concerning the quality system referred to in paragraph 3(1);

(c)the change referred to in paragraph 3(9), as approved;

(d)the decisions and reports of the [F215approved] body referred to in paragraphs 3(9), 4(3) and 4(4).

Extent Information

E65This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

6.  The manufacturer must, for a period ending 10 years after the radio equipment has been placed on the market, keep at the disposal of the national authorities—N.I.

(a)the technical documentation referred to in paragraph 3(1);

(b)the documentation concerning the quality system referred to in paragraph 3(1);

(c)the change referred to in paragraph 3(9), as approved;

(d)the decisions and reports of the notified body referred to in paragraphs 3(9), 4(3) and 4(4).

Extent Information

E155This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

7.—(1) Each [F216approved] body must inform [F217the Secretary of State] of quality system approvals which it has issued or withdrawn, and must, periodically or upon request, make available to [F217the Secretary of State] the list of quality system approvals refused, suspended or otherwise restricted.E+W+S

(2) Each [F218approved] body must inform the other [F218approved] bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

Extent Information

E66This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

7.—(1) Each notified body must inform its notifying authority of quality system approvals which it has issued or withdrawn, and must, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.N.I.

(2) Each notified body must inform the other notified bodies of quality system approvals which it has refused, suspended or withdrawn, and, upon request, of quality system approvals which it has issued.

Extent Information

E156This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Authorised representativeU.K.

8.  The manufacturer's obligations set out in paragraphs 3(1) and (9), 5 and 6 may be fulfilled by the manufacturer's authorised representative, on the manufacturer's behalf and under the manufacturer's responsibility, provided that they are specified in the mandate.

Regulation 45(2)(a)

SCHEDULE 5U.K.Contents of technical documentation

1.  The technical documentation must, wherever applicable, contain at least the following elements—E+W+S

(a)a general description of the radio equipment including—

(i)photographs or illustrations showing external features, marking and internal layout;

(ii)versions of software or firmware affecting conformity with the essential requirements;

(iii)user information and installation instructions;

(b)conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits and other relevant similar elements;

(c)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the radio equipment;

(d)a list of the [F219designated] standards applied in full or in part F220..., and, where those [F219designated] standards have not been applied, descriptions of the solutions adopted to meet the essential requirements, including a list of other relevant technical specifications applied. In the event of partly applied [F219designated] standards, the technical documentation must specify the parts which have been applied;

(e)copy of the F221... declaration of conformity;

(f)where the conformity assessment module in Schedule 3 ([F222Type] examination and conformity to type based on internal production control) has been applied, copy of the [F222Type] examination certificate and its annexes as delivered by the [F223approved] body involved;

(g)results of design calculations made, examinations carried out, and other relevant similar elements;

(h)test reports;

(i)an explanation of the compliance with the requirement of regulation 8 (construction must allow operation [F224without infringement of requirements]) and of the inclusion or not of information on the packaging in accordance with regulation 14 (information to be included where there are restrictions on putting into service or requirements for authorisation of use).

Extent Information

E67This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

1.  The technical documentation must, wherever applicable, contain at least the following elements—N.I.

(a)a general description of the radio equipment including—

(i)photographs or illustrations showing external features, marking and internal layout;

(ii)versions of software or firmware affecting conformity with the essential requirements;

(iii)user information and installation instructions;

(b)conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits and other relevant similar elements;

(c)descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the radio equipment;

(d)a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation must specify the parts which have been applied;

(e)copy of the EU declaration of conformity;

(f)where the conformity assessment module in Schedule 3 (EU-type examination and conformity to type based on internal production control) has been applied, copy of the EU-type examination certificate and its annexes as delivered by the notified body involved;

(g)results of design calculations made, examinations carried out, and other relevant similar elements;

(h)test reports;

(i)an explanation of the compliance with the requirement of regulation 8 (construction must allow operation in at least one [F362relevant state]) and of the inclusion or not of information on the packaging in accordance with regulation 14 (information to be included where there are restrictions on putting into service or requirements for authorisation of use).

Extent Information

E157This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Regulation 42(b)

SCHEDULE 6U.K.[F225EU] [F226declaration][F226Declaration] of conformity

Textual Amendments

EU [F226declaration] [F226Declaration] of conformity (No XXX) M24

Marginal Citations

M24It is optional for the manufacturer to assign a number to the EU declaration of conformity.

1.  Radio equipment (product, type, batch or serial number):U.K.

2.  Name and address of the manufacturer or his authorised representative:U.K.

3.  This declaration of conformity is issued under the sole responsibility of the manufacturer.U.K.

4.  Object of the declaration (identification of the radio equipment allowing traceability; it may include a colour image of sufficient clarity where necessary for the identification of the radio equipment):U.K.

5.  The object of the declaration described above is in conformity with the relevant [F227statutory requirements] E+W+S

Extent Information

E68This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

5.  The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:N.I.

Directive 2014/53/EU

Other Union harmonisation legislation where applicable

Extent Information

E158This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

6.  References to the relevant [F228designated] standards used or references to the other technical specifications in relation to which conformity is declared. References must be listed with their identification number and version and, where applicable, date of issue:E+W+S

Extent Information

E69This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

6.  References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared. References must be listed with their identification number and version and, where applicable, date of issue:N.I.

Extent Information

E159This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

7.  Where applicable, the [F229approved] body  (name, number)  performed  (description of intervention)  and issued the [F230Type] examination certificate:E+W+S

Extent Information

E70This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

7.  Where applicable, the notified body  (name, number)  performed  (description of intervention)  and issued the EU-type examination certificate:N.I.

Extent Information

E160This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

8.  Where applicable, description of accessories and components, including software, which allow the radio equipment to operate as intended and covered by the [F231EU] declaration of conformity:U.K.

  • Additional information:

  • Signed for and on behalf of:

  • (place and date of issue):

  • (name, function) (signature):

Textual Amendments

Regulation 43(1)

SCHEDULE 7U.K.Simplified [F232EU] declaration of conformity

Textual Amendments

1.  The simplified [F233EU] declaration of conformity referred to in regulation 13(3) (instructions and information to be included with the radio equipment) must be provided as follows—U.K.

Textual Amendments

2.  Hereby, [Name of manufacturer] declares that the radio equipment type [designation of type of radio equipment] is in compliance with [F234the relevant statutory requirements].E+W+S

Extent Information

E71This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

2.  Hereby, [Name of manufacturer] declares that the radio equipment type [designation of type of radio equipment] is in compliance with Directive 2014/53/EU.N.I.

Extent Information

E161This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

3.  The full text of the [F235EU] declaration of conformity is available at the following internet address:U.K.

Textual Amendments

Regulation 2(1)

SCHEDULE 8U.K.[F236Notified] [F236Approved] body requirements

Textual Amendments

[F2371.—(1) A conformity assessment body must have legal personality and must be established in—U.K.

(a)the United Kingdom; or

(b)the territory of a party to the CPTPP.

(2) In sub-paragraph (1) “the CPTPP” has the meaning set out in section 1 of the Trade (Comprehensive and Progressive Agreement for Trans-Pacific Partnership) Act 2024.]

Textual Amendments

2.—(1) A conformity assessment body must be a third-party body independent of the organisation or the radio equipment it assesses.U.K.

(2) A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, assembly, use or maintenance of radio equipment which it assesses may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered to satisfy sub-paragraph (1).

3.—(1) A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities must not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the radio equipment it assesses nor the representative of any of those parties.U.K.

(2) Sub-paragraph (1) does not preclude the use of assessed radio equipment that is necessary for the operations of the conformity assessment body or the use of such radio equipment for personal purposes.

4.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities must not be directly involved in the design, manufacture or construction, marketing, installation, use or maintenance of the radio equipment it assesses nor represent parties engaged in those activities.U.K.

5.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities must not engage in any activity, including consultancy services, that may conflict with their independence of judgment or integrity in relation to conformity assessment activities for which they are [F238approved].E+W+S

Extent Information

E72This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

5.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment activities must not engage in any activity, including consultancy services, that may conflict with their independence of judgment or integrity in relation to conformity assessment activities for which they are notified.N.I.

Extent Information

E162This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

6.  A conformity assessment body must ensure that the activities of its subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.U.K.

7.  A conformity assessment body and its personnel must carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.U.K.

8.  A conformity assessment body must be capable of carrying out all of the conformity assessment activities in relation to which it has been, or is to be, [F239approved], whether those activities are carried out by the conformity assessment body itself or on its behalf and under its responsibility.E+W+S

Extent Information

E73This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

8.  A conformity assessment body must be capable of carrying out all of the conformity assessment activities in relation to which it has been, or is to be, notified, whether those activities are carried out by the conformity assessment body itself or on its behalf and under its responsibility.N.I.

Extent Information

E163This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

9.  A conformity assessment body must have at its disposal—E+W+S

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment activities;

(b)descriptions of procedures in accordance with which conformity assessment is carried out ensuring the transparency and ability of reproduction of those procedures;

(c)policies and procedures in place to distinguish between activities that it carries out as a [F240approved] body and other activities;

(d)procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the radio equipment in question and the mass or serial nature of the production process.

Extent Information

E74This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

9.  A conformity assessment body must have at its disposal—N.I.

(a)personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment activities;

(b)descriptions of procedures in accordance with which conformity assessment is carried out ensuring the transparency and ability of reproduction of those procedures;

(c)policies and procedures in place to distinguish between activities that it carries out as a notified body and other activities;

(d)procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the technology of the radio equipment in question and the mass or serial nature of the production process.

Extent Information

E164This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

10.  A conformity assessment body must have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and must have access to the necessary equipment and facilities to perform these activities.U.K.

11.  The personnel responsible for carrying out the conformity assessment activities must have—E+W+S

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been [F241approved];

(b)satisfactory knowledge of the requirements of the assessments that they carry out and adequate authority to carry out those assessments;

(c)appropriate knowledge and understanding of the essential requirements, the applicable [F242designated] standards F243... and these Regulations;

(d)the ability to draw up [F244Type] examination certificates or quality system approvals, records and reports demonstrating that assessments have been carried out.

Extent Information

E75This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

11.  The personnel responsible for carrying out the conformity assessment activities must have—N.I.

(a)sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

(b)satisfactory knowledge of the requirements of the assessments that they carry out and adequate authority to carry out those assessments;

(c)appropriate knowledge and understanding of the essential requirements, the applicable harmonised standards, the Directive and these Regulations;

(d)the ability to draw up EU-type examination certificates or quality system approvals, records and reports demonstrating that assessments have been carried out.

Extent Information

E165This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

12.  A conformity assessment body must be able to demonstrate the impartiality of its top level management and the personnel responsible for carrying out the conformity assessment activities.U.K.

13.  The remuneration of the top level management and the personnel responsible for carrying out the conformity assessment activities must not depend on the number of assessments carried out or on the results of those assessments.U.K.

14.  A conformity assessment body must have, [F245and must satisfy the Secretary of State that it has], adequate civil liability insurance in respect of its activities.U.K.

Textual Amendments

15.  A conformity assessment body must ensure that its personnel observe professional secrecy with regard to all information obtained in carrying out their tasks in accordance with these Regulations and that proprietary rights are protected.U.K.

16.  Paragraph 15 does not prevent the personnel from providing information to the Secretary of State or an enforcing authority.U.K.

17.  A conformity assessment body must participate in, or ensure that its personnel who are responsible for carrying out the conformity assessment activities are informed of, the relevant standardisation activities and the activities of any [F246approved] body coordination group established [F247by the Secretary of State] and must apply as general guidance the administrative decisions and documents produced as a result of the work of that group.E+W+S

Extent Information

E76This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

17.  A conformity assessment body must participate in, or ensure that its personnel who are responsible for carrying out the conformity assessment activities are informed of, the relevant standardisation activities and the activities of any notified body coordination group established under the Directive and must apply as general guidance the administrative decisions and documents produced as a result of the work of that group.N.I.

Extent Information

E166This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Regulation 53

SCHEDULE 9U.K.Operational obligations of [F248notified] [F248approved] bodies

Textual Amendments

1.  [F249An approved] body must carry out conformity assessments in accordance with the relevant conformity assessment procedures in Schedule 3 (conformity assessment concerning EU-type examination) or Schedule 4 (conformity assessment concerning quality system approval).

Extent Information

E77This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

1.  A notified body must carry out conformity assessments in accordance with the relevant conformity assessment procedures in Schedule 3 (conformity assessment concerning EU-type examination) or Schedule 4 (conformity assessment concerning quality system approval).N.I.

Extent Information

E167This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

2.  [F250An approved] body must carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens on economic operators.

Extent Information

E78This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

2.  A notified body must carry out conformity assessments in a proportionate manner, avoiding unnecessary burdens on economic operators.N.I.

Extent Information

E168This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

3.  A conformity assessment body must perform its activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the radio equipment technology in question and the mass or serial nature of the production process.U.K.

4.  A conformity assessment body must respect the degree of rigour and the level of protection required to ensure that the radio equipment is in conformity with the requirements of these Regulations.U.K.

5.  Where [F251an approved] body finds that the essential requirements or the corresponding [F252designated] standards have not been met by the manufacturer, that body must require that manufacturer to take appropriate corrective measures and must not issue [F253a Type] examination certificate or quality system approval until the appropriate corrective measures have been taken.E+W+S

Extent Information

E79This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

5.  Where a notified body finds that the essential requirements or the corresponding harmonised standards have not been met by the manufacturer, that body must require that manufacturer to take appropriate corrective measures and must not issue an EU-type examination certificate or quality system approval until the appropriate corrective measures have been taken.N.I.

Extent Information

E169This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

6.  Where, in the course of the monitoring of conformity following the issue of [F254a Type] examination certificate or a quality system approval, [F255an approved] body finds that the radio equipment is no longer in conformity with the essential requirements, it must require the manufacturer to take appropriate corrective measures and must suspend or withdraw the [F256Type] examination certificate or quality system approval (if necessary).E+W+S

Extent Information

E80This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

6.  Where, in the course of the monitoring of conformity following the issue of an EU-type examination certificate or a quality system approval, a notified body finds that the radio equipment is no longer in conformity with the essential requirements, it must require the manufacturer to take appropriate corrective measures and must suspend or withdraw the EU-type examination certificate or quality system approval (if necessary).N.I.

Extent Information

E170This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

7.  Where the [F257approved] body has required a manufacturer to take corrective measures and the manufacturer has failed to take such measures, or those measures have not had the required effect, the [F257approved] body must restrict, suspend or withdraw any [F258Type] examination certificates or quality system approvals as appropriate.E+W+S

Extent Information

E81This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

7.  Where the notified body has required a manufacturer to take corrective measures and the manufacturer has failed to take such measures, or those measures have not had the required effect, the notified body must restrict, suspend or withdraw any EU-type examination certificates or quality system approvals as appropriate.N.I.

Extent Information

E171This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

8.  Paragraph 9 applies where [F259an approved] body is minded to—E+W+S

(a)refuse to issue [F260a Type] examination certificate,

(b)refuse to grant a quality system approval, or

(c)restrict, suspend or withdraw [F260a Type] examination certificate or quality system approval.

Extent Information

E82This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

8.  Paragraph 9 applies where a notified body is minded to—N.I.

(a)refuse to issue an EU-type examination certificate,

(b)refuse to grant a quality system approval, or

(c)restrict, suspend or withdraw an EU-type examination certificate or quality system approval.

Extent Information

E172This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

9.  Where this paragraph applies, the [F261approved] body must—E+W+S

(a)give the person applying for the [F262Type] examination certificate or quality system approval, or the person to whom the [F262Type] examination certificate or quality system approval was given—

(i)a notice in writing giving reasons and specifying the date on which the refusal, restriction, suspension or withdrawal is intended to take effect, and

(ii)an opportunity to make representations within a reasonable period from the date of the notice, and

(b)take account of any representations made under sub-paragraph (a)(ii) before taking its decision.

Extent Information

E83This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

9.  Where this paragraph applies, the notified body must—N.I.

(a)give the person applying for the EU-type examination certificate or quality system approval, or the person to whom the EU-type examination certificate or quality system approval was given—

(i)a notice in writing giving reasons and specifying the date on which the refusal, restriction, suspension or withdrawal is intended to take effect, and

(ii)an opportunity to make representations within a reasonable period from the date of the notice, and

(b)take account of any representations made under sub-paragraph (a)(ii) before taking its decision.

Extent Information

E173This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

10.  [F263An approved] body must inform the Secretary of State of—

(a)any refusal, restriction, suspension or withdrawal of [F264a Type] examination certificate or quality system approval in accordance with the requirements of Schedule 3 or Schedule 4 as appropriate,

(b)any circumstances affecting the scope of, or conditions for, [F265approval] under regulation 47 ([F266approval of conformity assessment bodies]),

(c)any request for information which it has received from an enforcing authority F267... regarding conformity assessment activities, and

(d)on request, conformity assessment activities performed within the scope of its notification under regulation 47 and any other activity performed, including cross-border activities and subcontracting.

Extent Information

E84This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

10.  A notified body must inform the Secretary of State of—N.I.

(a)any refusal, restriction, suspension or withdrawal of an EU-type examination certificate or quality system approval in accordance with the requirements of Schedule 3 or Schedule 4 as appropriate,

(b)any circumstances affecting the scope of, or conditions for, notification under regulation 47 (notification),

(c)any request for information which it has received from an enforcing authority or a competent national authority of another [F363relevant state] regarding conformity assessment activities, and

(d)on request, conformity assessment activities performed within the scope of its notification under regulation 47 and any other activity performed, including cross-border activities and subcontracting.

Extent Information

E174This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

11.  [F268An approved] body must make provision in its contracts with its clients enabling such clients to appeal against a decision—

(a)to refuse to issue [F269a Type] examination certificate or quality system approval decision, or

(b)to restrict, suspend or withdraw [F269a Type] examination certificate or quality system approval decision.

Extent Information

E85This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

11.  A notified body must make provision in its contracts with its clients enabling such clients to appeal against a decision—N.I.

(a)to refuse to issue an EU-type examination certificate or quality system approval decision, or

(b)to restrict, suspend or withdraw an EU-type examination certificate or quality system approval decision.

Extent Information

E175This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

12.  [F270An approved] body must, in accordance with the requirements in Schedule 3 and Schedule 4, provide other bodies [F271approved] under [F272these Regulations] carrying out similar conformity assessment activities covering the same type of radio equipment with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Extent Information

E86This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

12.  A notified body must, in accordance with the requirements in Schedule 3 and Schedule 4, provide other bodies notified under the Directive carrying out similar conformity assessment activities covering the same type of radio equipment with relevant information on issues relating to negative and, on request, positive conformity assessment results.N.I.

Extent Information

E176This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

13.  [F273An approved] body must participate in the work of any [F274approved] body coordination group established [F275by the Secretary of State], directly or by means of its designated representatives.

Extent Information

E87This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

13.  A notified body must participate in the work of any notified body coordination group established under the Directive, directly or by means of its designated representatives.N.I.

Extent Information

E177This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

14.  [F276An approved] body must fulfil any information obligations under Schedules 3 and 4.

Extent Information

E88This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

14.  A notified body must fulfil any information obligations under Schedules 3 and 4.N.I.

Extent Information

E178This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Regulation 55(3), 57(1)

SCHEDULE 10U.K.Enforcement and investigatory powers conferred on the enforcing authority and the market surveillance authority

PART 1U.K.Powers

Enforcement powers under the 1987 ActU.K.

1.  For the purposes of enforcing these Regulations, the following sections of the 1987 Act apply subject to the modifications in paragraph 2—

(a)section 13 (prohibition notices and notices to warn),

(b)section 14 (suspension notices),

(c)section 16 (forfeiture: England, Wales and Northern Ireland),

(d)section 17 (forfeiture: Scotland),

(e)section 18 (power to obtain information),

(f)section 29 (powers of search etc),

(g)section 30 (provisions supplemental to s 29),

(h)section 31 (power of customs officer to detain goods),

(i)section 33 (appeals against detention of goods),

(j)section 34 (compensation for seizure and detention),

(k)section 35 (recovery of expenses of enforcement),

(l)section 37 (power of Commissioners for Revenue and Customs to disclose information)),

(m)section 45 (interpretation),

(n)section 46(1) (meaning of “supply”), and

(o)Schedule 2 (prohibition notices and notices to warn).

Modifications to the 1987 ActU.K.

2.  The sections of the 1987 Act referred to in paragraph 1 are to apply as if—

(a)in section 13—

(i)in subsection (1), “relevant” were omitted on each occasion that it appears,

(ii)for “unsafe”, on each occasion that it appears, there were substituted “ non-compliant ”,

(iii)in subsection (2), the words from “; and the Secretary of State may” to the end were omitted, and

(iv)subsections (4) to (7) were omitted;

(b)in section 14—

(i)in subsection (1), after “any safety provision has been contravened in relation to any goods”, there were inserted “ or that such goods present a risk ”,

(ii)in subsection 2(b), after “a safety provision has been contravened in relation to the goods”, there were inserted “ or that such goods present a risk ”,

(iii)in subsection (2)(c), “under section 15 below” were omitted, and

(iv)subsections (6) to (8) were omitted;

(c)in section 16—

(i)in subsection (1), after “a contravention in relation to the goods of a safety provision”, there were inserted “ or that such goods present a risk ”,

(ii)for subsection 2(b) there were substituted—

“(b)where an application with respect to some or all of the goods has been made to a magistrates' court under regulation 73 (appeals against notices) of the 2017 Regulations or section 33, to that court; and”,

(iii)in subsection (3), after “a contravention in relation to the goods of a safety provision”, there were inserted “ or that such goods present a risk ”,

(iv)after subsection (4), there were inserted—

“(4A) A court may infer for the purposes of this section that any goods present a risk, if it is satisfied that such a risk is presented by goods which are representative of those goods (whether by reason of being of the same design or part of the same consignment or batch or otherwise).”,

(v)in subsection (6), the words “Subject to subsection (7) below,” were omitted, and

(vi)subsection (7) were omitted;

(d)in section 17—

(i)in subsection (1), after “a contravention of a safety provision”, there were inserted “ or where the goods present a risk ”,

(ii)in subsection (6), after “a contravention in relation to those goods of a safety provision”, there were inserted “ or that those goods present a risk ”, and

(iii)after subsection (7), there were inserted—

“(7A) The sheriff may infer for the purposes of this section that any goods present a risk, if the sheriff is satisfied that such a risk is presented by goods which are representative of those goods (whether by reason of being of the same design or part of the same consignment or batch or otherwise).”;

(e)in section 18, subsections (3) and (4) were omitted;

(f)in section 29—

(i)in subsection 4(a), after “any contravention of any safety provision in relation to the goods”, there were inserted “ or whether the goods present a risk ”; and

(ii)in subsection 4(b), after “any such contravention”, there were inserted “ or whether the goods present a risk ”;

(g)in section 30—

(i)at the end of subsection (2)(a)(ii), for “and” there were substituted “ or ”,

(ii)after subsection (2)(a)(ii), there were inserted—

“(iii)that any goods which any officer has power to inspect under section 29 are on any premises and their inspection is likely to demonstrate that they present a risk; and”, and

(iii)subsections (5), (7) and (8) were omitted;

(h)in section 31(1), for “Part II of this Act”, there were substituted “ the 2017 Regulations ”,

(i)in section 34—

(i)omit the word “and” at the end of subsection (1)(a), and

(ii)after that subsection, insert—

“(aa)the goods do not present a risk; and”,

(j)in section 37(1), for “Part II of this Act”, there were substituted “ the 2017 Regulations ”,

(k)in section 45(1)—

(i)the definitions of “conditional sale agreement”, “gas”, “motor vehicle”, “personal injury”, “subordinate legislation” and “substance” were omitted,

(ii)before the definition of “aircraft”, there were inserted—

““the 2017 Regulations” means the Radio Equipment Regulations 2017;”,

(iii)for the definition of “enforcement authority” there were substituted—

““enforcement authority” means an enforcing authority as defined in regulation 2(1) of the 2017 Regulations;”,

(iv)for the definition of “goods” there were substituted—

““goods” means radio equipment within the scope of the 2017 Regulations;”,

(v)after the definition of “motor vehicle”, there were inserted—

““non-compliant” in relation to any goods means that—

(a)a safety provision has been contravened in relation to the goods; or

(b)the goods present a risk”,

(vi)after the definition of “ premises” there were inserted—

““present a risk” means present a risk where “risk” has the meaning set out in regulation 2(5) of the 2017 Regulations;”,

(vii)for the definition of “safety provision” there were substituted—

““safety provision” means any provision of the 2017 Regulations;”, and

(viii)for the definition of “safety regulations” there were inserted—

““safety regulations” means the 2017 Regulations;”,

(l)in section 46(1), there were omitted from “and, in relation to gas or water” to the end; and

(m)in Schedule 2—

(i)for “unsafe”, on each occasion that it appears, there were substituted “ non-compliant ”, and

(ii)for “safe”, on each occasion that it appears, there were substituted “ not non-compliant ”.

Application of Schedule 5 to the Consumer Rights Act 2015U.K.

3.  Schedule 5 to the Consumer Rights Act 2015 (investigatory powers etc) M25 applies to OFCOM as if—

(a)OFCOM were a domestic enforcer within the meaning of that Schedule, and

(b)the enforcer's legislation within the meaning of that Schedule, in relation to OFCOM, were the legislation and notices which, by virtue of regulation 56(1)(a)(i) or (b)(i), OFCOM has a duty or power to enforce.

Marginal Citations

PART 2U.K.Notices

Compliance noticeU.K.

4.—(1) An enforcing authority may serve a compliance notice on a relevant economic operator in respect of radio equipment if the authority has reasonable grounds for believing that there is non-compliance.

(2) A compliance notice must—

(a)require the relevant economic operator on which it is served to—

(i)end the non-compliance within such period as may be specified in the notice, or

(ii)provide evidence, within such period as may be specified in the notice, demonstrating to the satisfaction of the enforcing authority that the non-compliance has not in fact occurred, and

(b)warn the economic operator that, if the non-compliance persists beyond, or if satisfactory evidence has not been produced within, the period specified in the notice, further action may be taken in respect of the radio equipment or any radio equipment of the same type made available on the market by that relevant economic operator.

(3) A compliance notice may include directions as to the measures to be taken by the economic operator to secure compliance, including different ways of securing compliance.

(4) Subject to sub-paragraph (5), an enforcing authority may revoke or vary a compliance notice by serving a notification on the economic operator.

(5) An enforcing authority may not vary a compliance notice so as to make it more restrictive for the economic operator or more onerous for the economic operator to comply.

Withdrawal noticeE+W+S

5.—(1) An enforcing authority may serve a withdrawal notice on a relevant economic operator in respect of radio equipment if the authority has reasonable grounds for believing that—

(a)the radio equipment has been made available on the market, and

(b)there is non-compliance.

(2) A withdrawal notice must prohibit the relevant economic operator from making the radio equipment available on the market without the consent of the enforcing authority.

(3) A withdrawal notice may require the relevant economic operator to take action to alert end-users to any risk presented by the radio equipment.

(4) A withdrawal notice may require the relevant economic operator to keep the enforcing authority informed of the whereabouts of any radio equipment referred to in the notice.

(5) A consent given by the enforcing authority pursuant to a withdrawal notice may impose such conditions on the making available on the market of the radio equipment as the enforcing authority considers appropriate.

(6) Subject to sub-paragraph (7), an enforcing authority may revoke or vary a withdrawal notice by serving a notification on the economic operator.

(7) An enforcing authority may not vary a withdrawal notice so as to make it more restrictive for the economic operator or more onerous for the economic operator to comply.

(8) A withdrawal notice has effect throughout the United Kingdom.

Extent Information

E89This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Withdrawal noticeN.I.

5.—(1) An enforcing authority may serve a withdrawal notice on a relevant economic operator in respect of radio equipment if the authority has reasonable grounds for believing that—

(a)the radio equipment has been made available on the market, and

(b)there is non-compliance.

(2) A withdrawal notice must prohibit the relevant economic operator from making the radio equipment available on the market without the consent of the enforcing authority.

(3) A withdrawal notice may require the relevant economic operator to take action to alert end-users to any risk presented by the radio equipment.

(4) A withdrawal notice may require the relevant economic operator to keep the enforcing authority informed of the whereabouts of any radio equipment referred to in the notice.

(5) A consent given by the enforcing authority pursuant to a withdrawal notice may impose such conditions on the making available on the market of the radio equipment as the enforcing authority considers appropriate.

(6) Subject to sub-paragraph (7), an enforcing authority may revoke or vary a withdrawal notice by serving a notification on the economic operator.

(7) An enforcing authority may not vary a withdrawal notice so as to make it more restrictive for the economic operator or more onerous for the economic operator to comply.

(8) A withdrawal notice has effect throughout [F364Northern Ireland].

Extent Information

E179This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

Recall noticeE+W+S

6.—(1) The enforcing authority may serve a recall notice on a relevant economic operator in respect of radio equipment if the authority has reasonable grounds for believing that—

(a)the radio equipment has been made available to end-users, and

(b)there is non-compliance.

(2) A recall notice must require the relevant economic operator to use reasonable endeavours to organise the return of the radio equipment from end-users to the relevant economic operator or another person specified in the notice.

(3) A recall notice may—

(a)require the relevant economic operator to—

(i)contact end-users in order to inform them of the recall, to the extent that it is practicable to do so,

(ii)publish a notice in such form and such manner as is likely to bring to the attention of end-users any risk the radio equipment poses and the fact of the recall, or

(iii)make arrangements for the collection or return of the radio equipment from end-users or its disposal, or

(b)impose such additional requirements on the relevant economic operator as are reasonable and practicable with a view to achieving the return of the radio equipment.

(4) In determining what requirements to include in a recall notice, the enforcing authority must take into consideration the need to encourage distributors and end-users to contribute to its implementation.

(5) A recall notice may only be issued by the enforcing authority where—

(a)other action which it may require under these Regulations would not suffice to address the non-compliance,

(b)the action being undertaken by the relevant economic operator is unsatisfactory or insufficient to address the non-compliance,

(c)the enforcing authority has given not less than 10 days' notice to the relevant economic operator of its intention to serve such a notice, and

(d)the enforcing authority has taken account of any advice obtained under sub-paragraph (6).

(6) A relevant economic operator which has received notice from the enforcing authority of an intention to serve a recall notice may at any time prior to the service of the recall notice require the authority to seek the advice of such person as the Institute determines on the questions of—

(a)whether there is non-compliance, and

(b)whether the issue of a recall notice would be proportionate.

(7) Sub-paragraph (5)(b), (c) and (d) do not apply in the case of radio equipment presenting a serious risk requiring, in the view of the enforcing authority, urgent action.

(8) Where a relevant economic operator requires the enforcing authority to seek advice under sub-paragraph (6), that relevant economic operator is to be responsible for the fees, costs and expenses of the Institute and of the person appointed by the Institute to advise the enforcing authority.

(9) In this paragraph, “Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators.

(10) A recall notice served by the enforcing authority may require the relevant economic operator to keep the authority informed of the whereabouts of radio equipment to which the recall notice relates, so far as the relevant economic operator is able to do so.

(11) Subject to sub-paragraph (12), an enforcing authority may revoke or vary a recall notice by serving a notification on the economic operator.

(12) An enforcing authority may not vary a recall notice so as to make it more restrictive for the economic operator or more onerous for the economic operator to comply.

(13) A recall notice has effect throughout the United Kingdom.

Extent Information

E90This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Recall noticeN.I.

6.—(1) The enforcing authority may serve a recall notice on a relevant economic operator in respect of radio equipment if the authority has reasonable grounds for believing that—

(a)the radio equipment has been made available to end-users, and

(b)there is non-compliance.

(2) A recall notice must require the relevant economic operator to use reasonable endeavours to organise the return of the radio equipment from end-users to the relevant economic operator or another person specified in the notice.

(3) A recall notice may—

(a)require the relevant economic operator to—

(i)contact end-users in order to inform them of the recall, to the extent that it is practicable to do so,

(ii)publish a notice in such form and such manner as is likely to bring to the attention of end-users any risk the radio equipment poses and the fact of the recall, or

(iii)make arrangements for the collection or return of the radio equipment from end-users or its disposal, or

(b)impose such additional requirements on the relevant economic operator as are reasonable and practicable with a view to achieving the return of the radio equipment.

(4) In determining what requirements to include in a recall notice, the enforcing authority must take into consideration the need to encourage distributors and end-users to contribute to its implementation.

(5) A recall notice may only be issued by the enforcing authority where—

(a)other action which it may require under these Regulations would not suffice to address the non-compliance,

(b)the action being undertaken by the relevant economic operator is unsatisfactory or insufficient to address the non-compliance,

(c)the enforcing authority has given not less than 10 days' notice to the relevant economic operator of its intention to serve such a notice, and

(d)the enforcing authority has taken account of any advice obtained under sub-paragraph (6).

(6) A relevant economic operator which has received notice from the enforcing authority of an intention to serve a recall notice may at any time prior to the service of the recall notice require the authority to seek the advice of such person as the Institute determines on the questions of—

(a)whether there is non-compliance, and

(b)whether the issue of a recall notice would be proportionate.

(7) Sub-paragraph (5)(b), (c) and (d) do not apply in the case of radio equipment presenting a serious risk requiring, in the view of the enforcing authority, urgent action.

(8) Where a relevant economic operator requires the enforcing authority to seek advice under sub-paragraph (6), that relevant economic operator is to be responsible for the fees, costs and expenses of the Institute and of the person appointed by the Institute to advise the enforcing authority.

(9) In this paragraph, “Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators.

(10) A recall notice served by the enforcing authority may require the relevant economic operator to keep the authority informed of the whereabouts of radio equipment to which the recall notice relates, so far as the relevant economic operator is able to do so.

(11) Subject to sub-paragraph (12), an enforcing authority may revoke or vary a recall notice by serving a notification on the economic operator.

(12) An enforcing authority may not vary a recall notice so as to make it more restrictive for the economic operator or more onerous for the economic operator to comply.

(13) A recall notice has effect throughout [F365Northern Ireland].

Extent Information

E180This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

InterpretationU.K.

7.  In this Schedule, “non-compliance” means that the radio equipment—

(a)presents a risk, or

(b)is not in conformity with Part 2 or RAMS (in its application to radio equipment).

Explanatory Note

(This note is not part of the Regulations)

These Regulations transpose Directive 2014/53/EU of the European Parliament and of the Council of 16 April 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC (OJ L 153, 22.5.2014, p.62) (“the Directive”).

The Directive repeals and replaces Directive 1999/5/EC of the European Parliament and of the Council of 9 March 1999 on radio equipment and telecommunications terminal equipment and the mutual recognition of their conformity (OJ L 91, 7.4.1999, p.10) which was implemented in the United Kingdom by the Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 (S.I. 2000/730). These Regulations revoke and replace S.I. 2000/730.

Regulations 3 to 5 set out the application of the Regulations to radio equipment, as defined in regulation 2. Regulation 2 contains definitions of many of the terms used in the Regulations.

Part 2 sets out the obligations of economic operators.

Regulation 6 defines what are the essential requirements that radio equipment must meet, which include the protection of the health and safety of persons, the protection of property, ensuring an adequate level of electromagnetic compatibility with other equipment, and avoiding harmful interference in the radio spectrum .

Regulations 7 to 18 set out the obligations that are specific to manufacturers. Obligations include ensuring that radio equipment has been designed and manufactured in accordance with the essential requirements, having a relevant conformity assessment procedure carried out before the radio equipment is placed on the market and affixing the CE marking. Regulation 19 sets out the obligations which an authorised representative, appointed by a manufacturer, must and must not perform on the manufacturer's behalf. It also provides that the authorised representative, as well as the manufacturer, is then responsible for the performance of those obligations

Regulations 20 to 29 set out the obligations that are specific to importers. These obligations include that the importer must not place on the market radio equipment which is not in conformity with the essential requirements, must check that the manufacturer has carried out a relevant conformity assessment procedure and must ensure the radio equipment bears the name and address of the importer. Regulation 25 includes an obligation to ensure that, while the importer is responsible for radio equipment, the storage and transport of the radio equipment does not jeopardise its conformity with the essential requirements.

Regulations 30 to 35 set out the obligations that are specific to distributors. These obligations include acting with due care to ensure that radio equipment is in conformity with Part 2 when making it available on the market, and checking that radio equipment bears the CE marking. Regulation 33 contains an obligation to ensure that, while the distributer is responsible for radio equipment, the storage and transport of the radio equipment does not jeopardise its conformity with the essential requirements.

Regulations 37 to 39 set out obligations which apply to all economic operators. These obligations include making sure that the EU declaration of conformity is in English before radio equipment is placed on the market in the United Kingdom. Those regulations also include an obligation to identify other economic operators in the supply chain on request from a market surveillance authority and a prohibition on the improper use of the CE marking.

Part 3 sets out provisions concerning the conformity assessment procedures, declarations of conformity and CE marking for radio equipment.

Part 4 sets out provisions concerning the bodies which carry out conformity assessment procedures under the Regulations.

Part 5 sets out provisions for market surveillance and enforcement of these Regulations. Regulation 55 identifies the market surveillance authorities and regulation 56 identifies the enforcing authorities. Regulation 57 and Schedule 10 provide for the powers of the enforcing and market surveillance authorities. Regulation 65 provides for the contravention of certain provisions of these Regulations to be an offence. Regulation 66 sets out the penalties that are to apply for offences under these Regulations.

Part 6 sets out a review provision and transitional provisions and consequential amendments. Regulation 78 revokes the Radio Equipment and Telecommunications Terminal Equipment Regulations 2000 (S.I. 2000/730) (as amended) and provides that they continue to apply to radio equipment placed on the market before the date these Regulations come into force. Regulations 79 to 85 make consequential amendments.

A transposition note and full impact assessment of the impact that these Regulations will have on the costs of business, the voluntary sector and the public sector are available from the Single Market Product Safety Team, Department for Business, Energy and Industrial Strategy, 1 Victoria Street, London SW1H 0ET and are also published with the Explanatory Memorandum alongside these Regulations on www.legislation.gov.uk.

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