The following shall be regarded as not being made available on the market:
radio kits for assembly and use by radio amateurs;
radio equipment modified by and for the use of radio amateurs;
equipment constructed by individual radio amateurs for experimental and scientific purposes related to amateur radio.
The manufacturer shall establish the technical documentation in accordance with Article 21.
The manufacturer shall 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 point 2 of this Annex and with the relevant essential requirements set out in Article 3.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
The manufacturer's obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
When reference is made to this Annex, the conformity assessment procedure shall follow Modules B (EU-type examination) and C (Conformity to type based on internal production control) of this Annex.
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
a written declaration that the same application has not been lodged with any other notified body;
the technical documentation. The technical documentation shall make it possible to assess the radio equipment's conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall 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 shall contain, wherever applicable, the elements set out in Annex V;
the supporting evidence for the adequacy of the technical design solution. That supporting evidence shall 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 shall 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 his behalf and under his responsibility.
The EU-type examination certificate and its annexes shall 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.
Where the type does not satisfy the applicable requirements of this Directive, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.
The manufacturer shall 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 this Directive or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.
Each notified body shall 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.
Each notified body shall inform the Member 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 of the European Union have not been applied or not been fully applied. The Member States, the 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 Member States and the Commission may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall 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.
The manufacturer shall 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 this Directive that apply to it.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
The manufacturer's obligations set out in point 3 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The manufacturer shall operate an approved quality system for design, manufacture, final radio equipment inspection and testing of the radio equipment concerned as specified in point 3 and shall be subject to surveillance as specified in point 4.
The application shall include:
the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
the technical documentation for each radio equipment type intended to be manufactured. The technical documentation shall contain, wherever applicable, the elements set out in Annex V;
the documentation concerning the quality system; and
a written declaration that the same application has not been lodged with any other notified body.
All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. That quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records.
It shall, in particular, contain an adequate description of:
the quality objectives and the organisational structure, responsibilities and powers of the management with regard to design and product quality;
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 this Directive that apply to the radio equipment will be met;
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;
the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;
the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;
the quality records, such as inspection reports and test data, calibration data, reports concerning the qualifications of the personnel, etc.;
the means of monitoring the achievement of the required design and product quality and the effective operation of the quality system.
It shall 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.
In addition to experience in quality management systems, the auditing team shall 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 this Directive. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 3.1(b) to verify the manufacturer's ability to identify the applicable requirements of this Directive and to carry out the necessary examinations with a view to ensuring compliance of the radio equipment with those requirements.
The manufacturer or his authorised representative shall be notified of the decision.
The notification shall contain the conclusions of the audit and the reasoned assessment decision.
The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 3.2 or whether a reassessment is necessary.
It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.
the quality system documentation;
the quality records as provided for by the design part of the quality system, such as results of analyses, calculations, tests, etc.;
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.
A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
the technical documentation referred to in point 3.1;
the documentation concerning the quality system referred to in point 3.1;
the change referred to in point 3.5, as approved;
the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.
Each notified body shall 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.
The manufacturer's obligations set out in points 3.1, 3.5, 5 and 6 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
The technical documentation shall, wherever applicable, contain at least the following elements:
a general description of the radio equipment including:
photographs or illustrations showing external features, marking and internal layout;
versions of software or firmware affecting compliance with essential requirements;
user information and installation instructions;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits and other relevant similar elements;
descriptions and explanations necessary for the understanding of those drawings and schemes and the operation of the radio equipment;
a list of the harmonised standards applied in full or in part the references of which have been published in the Official Journal of the European Union, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements set out in Article 3, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied;
copy of the EU declaration of conformity;
where the conformity assessment module in Annex III has been applied, copy of the EU-type examination certificate and its annexes as delivered by the notified body involved;
results of design calculations made, examinations carried out, and other relevant similar elements;
test reports;
an explanation of the compliance with the requirement of Article 10(2) and of the inclusion or not of information on the packaging in accordance with Article 10(10).
Directive 2014/53/EU
Other Union harmonisation legislation where applicable
Signed for and on behalf of: …
(place and date of issue):
(name, function) (signature):
The simplified EU declaration of conformity referred to in Article 10(9) shall be provided as follows:
Hereby, [Name of manufacturer] declares that the radio equipment type [designation of type of radio equipment] is in compliance with Directive 2014/53/EU.
The full text of the EU declaration of conformity is available at the following internet address:
| Directive 1999/5/EC | This Directive |
|---|---|
| Article 1 | Article 1 |
| Article 2 | Article 2 |
| Article 3(1) and (2) | Article 3(1) and (2) |
| Article 3(3) and Article 15a | Article 3(3), with the exception of Article 3(3)(i), and Article 44 |
| Article 4(1) and Articles 13 to 15 | Articles 8 and 45 |
| Article 4(2) | — |
| Article 5(1) | Article 16 |
| Article 5(2) and (3) | — |
| Article 6(1) | Article 6 |
| Article 6(2) | — |
| Article 6(3) | Article 10(8), (9) and (10) |
| Article 6(4) | — |
| Article 7(1) and (2) | Article 7 |
| Article 7(3), (4) and (5) | — |
| Article 8(1) and (2) | Article 9 |
| Article 8(3) | — |
| Article 9 | Articles 39 to 43 |
| Article 10 | Article 17 |
| Article 11 | Articles 22 to 38 |
| Article 12 | Articles 19 and 20 and Article 10(6) and (7) |
| Article 16 | — |
| Article 17 | Article 47 |
| Article 18 | Article 48 |
| Article 19 | Article 49 |
| Article 20 | Article 50 |
| Article 21 | Article 51 |
| Article 22 | Article 52 |
| Annex I | Annex I |
| Annex II | Annex II |
| Annex III | — |
| Annex IV | Annex III |
| Annex V | Annex IV |
| Annex VI | Article 26 |
| Annex VII(1) to (4) | Articles 19 and 20 |
| Annex VII(5) | Article 10(10) |
Council Directive 96/98/EC of 20 December 1996 on marine equipment (OJ L 46, 17.2.1997, p. 25).
Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (OJ L 79, 19.3.2008, p. 1).
It is optional for the manufacturer to assign a number to the EU declaration of conformity.