After regulation 2 insert—

“Designated standard2A.

(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, 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).

(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 technical specifications adopted by the other recognised standardisation bodies.

(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.”.

After regulation 6 insert—

“Power to specify additional essential requirements6A.

(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.”.

In regulation 16 (provision of information and cooperation) for paragraph (1) substitute—

“(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.”.

After regulation 18 (monitoring) insert—

“Provision of information on compliance of combinations of radio equipment and software18A.

(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.

Power to amend R14(2)(b) and specify how information is to be presented18B.

(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.”.

After regulation 36 insert—

“Obligations which are met by complying with obligations in the Directive36A.

(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 16.

(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.

F11Expiry of regulation 36A36B.

(1)

Subject to paragraph (2), regulation 36A ceases to have effect at the end of the period of 12 months beginning with IP completion day.

(2)

Notwithstanding the expiry of regulation 36A—

(a)

any radio equipment which was placed on the market pursuant to regulation 36A may continue to be made available on the market on or after the expiry of regulation 36A;

(b)

any obligation to which a person was subject under regulation 36A in respect of any radio equipment placed on the market pursuant to regulation 36A continues to have effect after the expiry of regulation 36A, in respect of that equipment.

Qualifying Northern Ireland Goods36C.

(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.”.

For Part 4 notification of conformity assessment bodies), substitute—

“PART 4Approval of conformity assessment bodies

Approved bodies46.

(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 F14IP 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 F14IP 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 F14IP 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 F14IP completion day;

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

Approval of conformity assessment bodies47.

(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.

Presumption of conformity of approved bodies48.

(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.

Monitoring49.

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 F15IP completion day, in accordance with regulation 47(6)(b), as it applied immediately beforeF15IP completion day; and

(c)

carries out its functions in accordance with these Regulations.

Restriction, suspension or withdrawal of approval50.

(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.

Operational matters in relation to approved bodies51.

(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).

Subsidiaries and contractors52.

(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 M1.

Register of approved bodies53.

(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.

UK national accreditation body54.

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.”.

After regulation 76 insert—

“Transitional provision in relation to EU Exit76A.

(1)

In this regulation—

“pre-exit period” means the period beginning with the commencement date and ending immediately before F16IP 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 M3, any obligation to which a person was subject under these Regulations as they had effect immediately before F16IP completion day, continues to have effect as it did immediately before F16IP 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.

(4)

Where during the pre-exit period—

(a)

a product has not been placed on the market; and

(b)

a manufacturer has taken any action under regulation 41 as it had effect immediately before F16IP completion day in relation to that product,

that action has effect as if it had been done under regulation 41 as it has effect on and after F16IP completion day.”.