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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 Text with EEA relevance

Type Directive
Publication 2014-05-22
Last updated 2026-05-30
State In force
Department Council of the European Union, European Parliament
Source EUR-Lex
articles 60
Reform history JSON API
4.

The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide by means of implementing acts whether the national measure is justified or not and, where necessary, propose appropriate measures.

The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the examination procedure referred to in Article 45(3).

On duly justified imperative grounds of urgency relating to the protection of health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 45(4).

5.

The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.

Article 43

Formal non-compliance
1.

Without prejudice to Article 40, where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:

  • (a) the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 20 of this Directive;
  • (b) the CE marking has not been affixed;
  • (c) the identification number of the notified body, where the conformity assessment procedure set out in Annex IV is applied, has been affixed in violation of Article 20 or has not been affixed;
  • (d) the EU declaration of conformity has not been drawn up;
  • (e) the EU declaration of conformity has not been drawn up correctly;
  • (f) technical documentation is either not available or not complete;
  • (fa) the pictogram as referred to in Article 3a(2), or the label as referred to in Article 10(8), has not been drawn up correctly;
  • (fb) the label as referred to in Article 10(8) does not accompany the radio equipment concerned;
  • (fc) the pictogram or the label is not affixed or displayed in accordance with Article 3a(2) or Article 10(8), respectively;
  • (g) the information referred to in Article 10(6) or (7) or Article 12(3) is absent, false or incomplete;
  • (h) the information referred to in Article 10(8), the EU declaration of conformity referred to in Article 10(9) or the information on usage restrictions referred to in Article 10(10) does not accompany the radio equipment;
  • (i) requirements on identification of economic operators set out in Article 15 are not fulfilled;
  • (j) Article 3a(1) or Article 5 is not complied with.
2.

Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit corresponding radio equipment being made available on the market or ensure that it is withdrawn or recalled from the market.

Chapter Va Emergency procedures

Article 43a

Application of emergency procedures

1.

Member States shall ensure that measures taken to transpose Articles 43b to 43e of this Directive apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to radio equipment covered by this Directive.

2.

Member States shall ensure that measures taken to transpose Articles 43b to 43e of this Directive apply only to radio equipment which has been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.

3.

Member States shall ensure that measures taken to transpose Articles 43b to 43e of this Directive apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747.

However, Article 43c(7) of this Directive shall apply during the internal market emergency mode and after its expiry or deactivation.

4.

The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to radio equipment placed on the market in accordance with Articles 43c and 43d. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(3).

Article 43b

Prioritisation of the conformity assessment of radio equipment designated as crisis-relevant goods

1.

This Article applies to radio equipment listed in the implementing act referred to in Article 43a(1) that is subject to the conformity assessment procedures referred to in Article 17 that require the mandatory involvement of a notified body.

2.

The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of radio equipment referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 43a.

3.

The prioritisation of applications for a conformity assessment of radio equipment pursuant to paragraph 2 shall not result in additional disproportionate costs for the manufacturers who have lodged those applications.

4.

The notified bodies shall make reasonable efforts to increase their testing capacities for radio equipment referred to in paragraph 1 in respect of which they have been notified.

Article 43c

Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body

1.

By way of derogation from Article 17, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market within the territory of that Member State, of specific radio equipment listed in the implementing act referred to in Article 43a(1) and for which the conformity assessment procedures referred to in Article 17 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the relevant essential requirements set out in Article 3 has been demonstrated in accordance with procedures referred to in that authorisation.

2.

The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 of this Article. Provided that the requirements set out in the authorisation ensure conformity with the relevant essential requirements set out in Article 3, the Commission shall adopt, without delay, an implementing act extending the validity of the authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the whole Union and shall set out the conditions under which the specific radio equipment may be placed on the market. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 45(3).

The radio equipment subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market as a ‘crisis-relevant good’. The implementing act referred to in the first subparagraph shall specify the content and presentation of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.

3.

On duly justified imperative grounds of urgency relating to the need to preserve the health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 45(4).

4.

As long as an implementing act as referred to in paragraph 2 or 3 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

5.

Manufacturers of radio equipment subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the radio equipment concerned complies with all the relevant essential requirements set out in Article 3 and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority.

6.

Any authorisation issued pursuant to paragraph 1 shall set out the conditions and requirements under which the radio equipment may be placed on the market. Such authorisations shall set out at least the following:

  • (a) a description of the procedures, by means of which compliance with the relevant essential requirements set out in Article 3 of this Directive was successfully demonstrated;
  • (b) any specific requirements regarding the traceability of the radio equipment concerned;
  • (c) an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated in accordance with Article 18 Regulation (EU) 2024/2747;
  • (d) any specific requirements regarding the need to ensure a continuous conformity assessment with respect to the radio equipment concerned;
  • (e) measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the radio equipment concerned that has been placed on the market.
7.

By way of derogation from Articles 9, 19 and 20, radio equipment for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and Article 9 shall not apply.

8.

The market surveillance authorities of a Member State where an authorisation pursuant to paragraphs 1, 2 and 4 of this Article is valid shall be entitled, with respect to such radio equipment, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 of the European Parliament and of the Council ([^E0003]) and under this Directive. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions.

9.

The use of the authorisation procedure set out in paragraphs 1 to 4 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Article 17.

Article 43d

Presumption of conformity based on standards and common specifications

1.

Where radio equipment has been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts listing appropriate standards or establishing common specifications for such radio equipment to cover the relevant essential requirements set out in Article 3 of this Directive in the following cases:

  • (a) where a reference to harmonised standards covering the relevant essential requirements set out in Article 3 of this Directive has not been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period; or
  • (b) where severe disruptions to the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities of manufacturers to make use of the harmonised standards that cover the relevant essential requirements set out in Article 3 of this Directive and the references of which have already been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.
2.

The implementing acts referred to in paragraph 1 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts.

3.

The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 45(3) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article.

4.

Before preparing the draft implementing act referred to in paragraph 1 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions in paragraph 1 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Directive and shall duly consult all relevant stakeholders.

5.

Without prejudice to Article 16, radio equipment that is in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the relevant essential requirements set out in Article 3 that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article.

6.

By way of derogation from Article 43a(3), first subparagraph, unless there is sufficient reason to believe that the radio equipment covered by the standards or common specifications referred to in paragraph 1 of this Article presents a risk to the health or safety of persons, the radio equipment that is in conformity with those standards or common specifications and which has been placed on the market shall be deemed to be in conformity with the relevant essential requirements set out in Article 3 after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode.

7.

When a Member State considers that a standard or common specification as referred to in paragraph 1 of this Article does not entirely satisfy the relevant essential requirements set out in Article 3, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend or repeal the implementing act listing the standard or establishing the common specification in question.

Article 43e

Prioritisation of market surveillance activities and mutual assistance among authorities

1.

Member States shall prioritise the market surveillance activities for radio equipment listed in the implementing act referred to in Article 43a(1) of this Directive. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.

2.

The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency mode, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support, such as the reinforcement of the testing capacity for radio equipment listed in the implementing act referred to in Article 43a(1).

CHAPTER VI DELEGATED ACTS AND IMPLEMENTING ACTS AND THE COMMITTEE

Article 44

Exercise of the delegation
1.

The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.

The power to adopt delegated acts referred to in the second subparagraph of Articles 3(3), 4(2) and 5(2) shall be conferred on the Commission for a period of five years from 11 June 2014.  The power to adopt delegated acts referred to in Article 3(4), Article 3a(2), second subparagraph, and Article 10(8), fifth subparagraph, shall be conferred on the Commission for a period of 5 years from 27 December 2022. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3.

The delegation of power referred to in Article 3(3), second subparagraph, Article 3(4), Article 3a(2), second subparagraph, Article 4(2), Article 5(2) and Article 10(8), fifth subparagraph, may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

3a. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making ([^E0004]).

4.

As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

5.

A delegated act adopted pursuant to Article 3(3), second subparagraph, Article 3(4), Article 3a(2), second subparagraph, Article 4(2), Article 5(2) or Article 10(8), fifth subparagraph, shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.

Article 45

Committee procedure
1.

The Commission shall be assisted by the Telecommunication Conformity Assessment and Market Surveillance Committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.

Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

3.

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

4.

Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

5.

The committee shall be consulted by the Commission on any matter for which consultation of sectoral experts is required by Regulation (EU) No 1025/2012 or by any other Union legislation.

The committee may furthermore examine any other matter concerning the application of this Directive raised either by its chair or by a representative of a Member State in accordance with its rules of procedure.

CHAPTER VII FINAL AND TRANSITIONAL PROVISIONS

Article 46

Penalties

Member States shall lay down rules on penalties applicable to infringements by economic operators of the provisions of national law adopted pursuant to this Directive and shall take all measures necessary to ensure that they are enforced. Such rules may include criminal penalties for serious infringements.

The penalties provided for shall be effective, proportionate and dissuasive.

Article 47

Review and reporting
1.

Member States shall submit to the Commission reports on the application of this Directive by 12 December 2027, covering the period from 13 June 2023, and every 5 years thereafter. The reports shall contain a presentation of the market surveillance activities performed by the Member States and provide information on whether and to what extent compliance with the requirements of this Directive has been attained, including in particular requirements on identification of economic operators.

2.

The Commission shall review the operation of this Directive and report thereon to the European Parliament and to the Council, by 12 June 2018 and every five years thereafter. The report shall cover progress on drawing up the relevant standards, as well as any problems that have arisen in the course of implementation. The report shall also outline the activities of the Telecommunication Conformity Assessment and Market Surveillance Committee, assess progress in achieving an open competitive market for radio equipment at Union level and examine how the regulatory framework for the making available on the market and putting into service of radio equipment should be developed in order to achieve the following:

  • (a) ensure that a coherent system is achieved at Union level for all radio equipment;
  • (b) allow for convergence of the telecommunications, audiovisual and information technology sectors;
  • (c) enable regulatory measures to be harmonised at international level;
  • (d) reach a high level of consumer protection;
  • (e) ensure that portable radio equipment interworks with accessories, in particular with common chargers;
  • (f) where radio equipment is fitted with an integral screen, allow the display of the required information on the integral screen.
3.

By 28 December 2026, the Commission shall submit to the European Parliament and the Council a report on the impact of the possibility to acquire radio equipment without any charging device and without cables, particularly with regard to consumer convenience, the reduction of environmental waste, behavioural changes and the development of market practices. That report shall be accompanied, if appropriate, by a legislative proposal to amend this Directive to introduce mandatory unbundling of the sale of charging devices and cables from the sale of radio equipment.

Article 48

Transitional provisions

Member States shall not impede, for the aspects covered by this Directive, the making available on the market or putting into service of radio equipment covered by this Directive which is in conformity with the relevant Union harmonisation legislation applicable before 13 June 2016 and which was placed on the market before 13 June 2017.

Article 49

Transposition
1.

Member States shall adopt and publish, by 12 June 2016, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate the text of those measures to the Commission.

They shall apply those measures from 13 June 2016.

When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. They shall also include a statement that references in existing laws, regulations and administrative provisions to the Directive repealed by this Directive shall be construed as references to this Directive. Member States shall determine how such reference is to be made and how that statement is to be formulated.

2.

Member States shall communicate to the Commission the texts of the main provisions of national law which they adopt in the field covered by this Directive.

Article 50

Repeal

Directive 1999/5/EC is repealed with effect from 13 June 2016.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex VIII.

Article 51

Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 52

Addressees

This Directive is addressed to the Member States.

ANNEX I

EQUIPMENT NOT COVERED BY THIS DIRECTIVE

  • 1.Radio equipment used by radio amateurs within the meaning of Article 1, definition 56, of the International Telecommunications Union (ITU) Radio Regulations, unless the equipment is made available on the market.
  • The following shall 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;
  • (c) equipment constructed by individual radio amateurs for experimental and scientific purposes related to amateur radio.
  • 2.Marine equipment falling within the scope of Council Directive 96/98/EC ([^E0005]).
  • 3.The following aviation equipment, where that equipment falls within the scope of Regulation (EU) 2018/1139 of the European Parliament and of the Council ([^E0006]) and is intended exclusively for airborne use:
  • (a) aircraft, other than unmanned aircraft, as well as associated engines, propellers, parts and non-installed equipment;
  • (b) unmanned aircraft, as well as associated engines, propellers, parts and non-installed equipment, the design of which is certified in accordance with Article 56(1) of that Regulation and which are intended to operate only on frequencies allocated by the Radio Regulations of the International Telecommunications Union for protected aeronautical use.
  • 4.Custom-built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes.

ANNEX Ia

SPECIFICATIONS AND INFORMATION RELATING TO CHARGING APPLICABLE TO CERTAIN CATEGORIES OR CLASSES OF RADIO EQUIPMENT

Part I

Specifications relating to charging capabilities

  • 1.The requirements set out in points 2 and 3 of this Part shall apply to the following categories or classes of radio equipment:
  • 1.1. handheld mobile phones;
  • 1.2. tablets;
  • 1.3. digital cameras;
  • 1.4. headphones;
  • 1.5. headsets;
  • 1.6. handheld videogame consoles;
  • 1.7. portable speakers;
  • 1.8. e-readers;
  • 1.9. keyboards;
  • 1.10. mice;
  • 1.11. portable navigation systems;
  • 1.12. earbuds;
  • 1.13. laptops.
  • 2.In so far as they are capable of being recharged by means of wired charging, the categories or classes of radio equipment referred to in point 1 of this Part shall:
  • 2.1. be equipped with the USB Type-C receptacle, as described in the standard  EN IEC 62680-1-3:2022‘Universal serial bus interfaces for data and power – Part 1-3: Common components – USB Type-C® Cable and Connector Specification’, and that receptacle shall remain accessible and operational at all times;
  • 2.2. be capable of being charged with cables which comply with the standard  EN IEC 62680-1-3:2022‘Universal serial bus interfaces for data and power – Part 1-3: Common components – USB Type-C® Cable and Connector Specification’.
  • 3.In so far as they are capable of being recharged by means of wired charging at voltages higher than 5 Volts, currents higher than 3 Amperes or powers higher than 15 Watts, the categories or classes of radio equipment referred to in point 1 of this Part shall:
  • 3.1. incorporate the USB Power Delivery, as described in the standard  EN IEC 62680-1-2:2022‘Universal serial bus interfaces for data and power – Part 1-2: Common components – USB Power Delivery specification’;
  • 3.2. ensure that any additional charging protocol allows for the full functionality of the USB Power Delivery referred to in point 3.1, irrespective of the charging device used.

Part II

Information on specifications relating to charging capabilities and the compatible charging devices

In the case of radio equipment falling within the scope of Article 3(4), first subparagraph, the following information shall be indicated in accordance with the requirements set out in Article 10(8), and may be made available in addition by means of QR codes or similar electronic solutions:

  • (a) in the case of all categories or classes of radio equipment which are subject to the requirements set out in Part I, a description of the power requirements of the wired charging devices that can be used with that radio equipment, including the minimum power required to charge the radio equipment, and the maximum power required to charge the radio equipment at the maximum charging speed expressed in Watts by displaying the text: ‘the power delivered by the charger must be between min [xx] Watts required by the radio equipment, and max [yy] Watts in order to achieve the maximum charging speed’. The number of Watts shall express, respectively, the minimum power required by the radio equipment, and the maximum power required by the radio equipment to achieve the maximum charging speed;
  • (b) in the case of radio equipment which is subject to the requirements set out in point 3 of Part I, a description of the specifications relating to charging capabilities of the radio equipment, in so far as it is capable of being recharged by means of wired charging at voltages higher than 5 Volts or currents higher than 3 Amperes or powers higher than 15 Watts, including an indication that the radio equipment supports the USB Power Delivery charging protocol by displaying the text ‘USB PD fast charging’ and an indication of any other supported charging protocol by displaying its name in text format.

Part III

Pictogram indicating whether or not a charging device is included with the radio equipment

  • 1.The pictogram shall have the following formats:
  • 2.The pictogram may vary in appearance (e.g. as to its colour, solid or hollow, line thickness), provided that it remains visible and legible. If the pictogram is reduced or enlarged, the proportions set out in the drawings in point 1 of this Part shall be maintained. The dimension ‘a’ referred to in point 1 of this Part shall be greater than or equal to 7 mm, irrespective of the variation.

Part IV

Content and format of the label

  • 1.The label shall have the following format:
  • 2.The letters ‘XX’ shall be replaced by the figure corresponding to the minimum power required by the radio equipment to charge, which determines the minimum power that a charging device needs to supply to charge the radio equipment. The letters ‘YY’ shall be replaced by the figure corresponding to the maximum power required by the radio equipment to achieve maximum charging speed, which determines the power that a charging device needs to supply at least to achieve that maximum charging speed. The abbreviation ‘USB PD’ (USB Power Delivery) shall be displayed if the radio equipment supports that charging communication protocol. ‘USB PD’ is a protocol that negotiates the fastest delivery of current from the charging device to the radio equipment without shortening the battery lifetime.
  • 3.The label may vary in appearance (e.g. as to its colour, solid or hollow, line thickness), provided that it remains visible and legible. If the label is reduced or enlarged, the proportions set out in the drawing in point 1 of this Part shall be maintained. The dimension ‘a’ referred to in point 1 of this Part shall be greater than or equal to 7 mm, irrespective of the variation.

ANNEX II

CONFORMITY ASSESSMENT MODULE A

INTERNAL PRODUCTION CONTROL

    1. Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4 of this Annex, and ensures and declares on his sole responsibility that the radio equipment concerned satisfies the essential requirements set out in Article 3.
    1. Technical documentation

The manufacturer shall establish the technical documentation in accordance with Article 21.

    1. Manufacturing

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.

    1. CE marking and EU declaration of conformity
  • 4.1.The manufacturer shall affix the CE marking in accordance with Articles 19 and 20 to each item of radio equipment that satisfies the applicable requirements of this Directive.
  • 4.2.The manufacturer shall 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 shall identify the radio equipment for which it has been drawn up.
  • A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
    1. Authorised representative

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.

ANNEX III

CONFORMITY ASSESSMENT MODULES B AND C

EU-TYPE EXAMINATION AND CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL

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.

Module B

EU-type examination

    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 set out in Article 3.
    1. EU-type examination shall 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 point 3, without examination of a specimen (design type).
    1. The manufacturer shall lodge an application for EU-type examination with a single notified body of his choice.

The application shall include:

  • (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his 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 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;
  • (d) 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.
    1. The notified body shall examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the radio equipment.
    1. The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations as provided in point 8, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.
    1. Where the type meets the requirements of this Directive that apply to the radio equipment concerned, the notified body shall issue an EU-type examination certificate to the manufacturer. That certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the aspects of the essential requirements covered by the examination, the conditions (if any) for its validity and the necessary data for identification of the assessed type. The EU-type examination certificate may have one or more annexes attached.

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.

    1. The notified body shall keep itself apprised 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 this Directive, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

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.

    1. Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, 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.

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.

    1. The manufacturer shall 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.
    1. The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9, provided that they are specified in the mandate.

Module C

Conformity to type based on internal production control

    1. 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 points 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 this Directive that apply to it.
    1. Manufacturing

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.

    1. CE marking and EU declaration of conformity
  • 3.1.The manufacturer shall affix the CE marking in accordance with Articles 19 and 20 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 this Directive.
  • 3.2.The manufacturer shall 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 shall identify the radio equipment type for which it has been drawn up.
  • A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
    1. Authorised representative

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.

ANNEX IV

CONFORMITY ASSESSMENT MODULE H

CONFORMITY BASED ON FULL QUALITY ASSURANCE

    1. Conformity based on full quality assurance is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 5, and ensures and declares on his sole responsibility that the radio equipment concerned satisfies the requirements of this Directive that apply to it.
    1. Manufacturing

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.

    1. Quality system
  • 3.1.The manufacturer shall lodge an application for assessment of his quality system with the notified body of his choice, for the radio equipment concerned.
  • The application shall include:
  • (a) the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;
  • (b) 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;
  • (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.
  • 3.2.The quality system shall ensure compliance of the radio equipment with the requirements of this Directive that apply to it.
  • 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:
  • (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 this Directive 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.
  • 3.3.The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 3.2.
  • 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.
  • 3.4.The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.
  • 3.5.The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.
  • 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.
    1. Surveillance under the responsibility of the notified body
  • 4.1.The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.
  • 4.2.The manufacturer shall, for assessment purposes, allow the notified body access to the design, manufacture, inspection, testing and storage sites, and shall 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.
  • 4.3.The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.
  • 4.4.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 shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.
    1. CE marking and EU declaration of conformity
  • 5.1.The manufacturer shall affix the CE marking in accordance with Articles 19 and 20 and, under the responsibility of the notified body referred to in point 3.1, the latter's identification number to each item of radio equipment that satisfies the applicable requirements set out in Article 3.
  • 5.2.The manufacturer shall 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 shall identify the radio equipment type for which it has been drawn up.
  • A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
    1. The manufacturer shall, for a period ending 10 years after the radio equipment has been placed on the market, keep at the disposal of the national authorities:
  • (a) the technical documentation referred to in point 3.1;
  • (b) the documentation concerning the quality system referred to in point 3.1;
  • (c) the change referred to in point 3.5, as approved;
  • (d) the decisions and reports of the notified body referred to in points 3.5, 4.3 and 4.4.
    1. Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.

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.

    1. Authorised representative

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.

ANNEX V

CONTENTS OF TECHNICAL DOCUMENTATION

The technical documentation shall, wherever applicable, contain at least the following elements:

  • (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 compliance with 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 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;
  • (e) copy of the EU declaration of conformity;
  • (f) 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;
  • (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 Article 10(2) and of the inclusion or not of information on the packaging in accordance with Article 10(10).

ANNEX VI

EU DECLARATION OF CONFORMITY (No XXX) ([^E0007])

  • 1.Radio equipment (product, type, batch or serial number):
  • 2.Name and address of the manufacturer or his authorised representative:
  • 3.This declaration of conformity is issued under the sole responsibility of the manufacturer.
  • 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):
  • 5.The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:

Directive 2014/53/EU

Other Union harmonisation legislation where applicable

  • 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:
  • 7.Where applicable, the notified body … (name, number) … performed … (description of intervention) … and issued the EU-type examination certificate: …
  • 8.Where applicable, description of accessories and components, including software, which allow the radio equipment to operate as intended and covered by the EU declaration of conformity:
  • 9.Additional information:

Signed for and on behalf of: …

(place and date of issue):

(name, function) (signature):

ANNEX VII

SIMPLIFIED EU DECLARATION OF CONFORMITY

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:

ANNEX VIII

CORRELATION TABLE

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)

STATEMENT OF THE EUROPEAN PARLIAMENT

The European Parliament considers that only when and insofar as implementing acts in the sense of Regulation (EU) No 182/2011 are discussed in meetings of committees, can the latter be considered as ‘comitology committees’ within the meaning of Annex I to the Framework Agreement on the relations between the European Parliament and the European Commission. Meetings of committees thus fall within the scope of point 15 of the Framework Agreement when and insofar as other issues are discussed.

[^E0001]: Directive 2002/21/EC of the European Parliament and of the Council of 7 March 2002 on a common regulatory framework for electronic communications networks and services (Framework Directive) (OJ L 108, 24.4.2002, p. 33).

[^E0002]: Regulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) (OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj).

[^E0003]: Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1).

[^E0004]: OJ L 123, 12.5.2016, p. 1.

[^E0005]: Council Directive 96/98/EC of 20 December 1996 on marine equipment (OJ L 46, 17.2.1997, p. 25).

[^E0006]: Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (OJ L 212, 22.8.2018, p. 1).

[^E0007]: It is optional for the manufacturer to assign a number to the EU declaration of conformity.

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