EdLaw
Conformity assessment, EU declaration and CE marking
The conformity routes (Module A only where harmonised standards fully cover Article 3; Modules B+C or H otherwise), the EU declaration of conformity including the simplified form, and the CE marking rules.
Article 17 — Conformity assessment procedures
Verbatim from EUR-Lex (Directive 2014/53/EU (RED) 02014L0053-20260530), via the Publications Office Cellar API.
1. The manufacturer shall perform a conformity assessment of the radio equipment with a view to meeting the essential requirements set out in Article 3. The conformity assessment shall take into account all intended operating conditions and, for the essential requirement set out in point (a) of Article 3(1), the assessment shall also take into account the reasonably foreseeable conditions. Where the radio equipment is capable of taking different configurations, the conformity assessment shall confirm whether the radio equipment meets the essential requirements set out in Article 3 in all possible configurations.
2. Manufacturers shall demonstrate compliance of radio equipment with the essential requirements set out in Article 3(1) and (4) using any of the following conformity assessment procedures:
- (a) internal production control set out in Annex II;
- (b) EU-type examination that is followed by the conformity to type based on internal production control set out in Annex III;
- (c) conformity based on full quality assurance set out in Annex IV.
3. Where, in assessing the compliance of radio equipment with the essential requirements set out in Article 3(2) and (3), the manufacturer has applied harmonised standards the references of which have been published in the Official Journal of the European Union, he shall use any of the following procedures:
- (a) internal production control set out in Annex II;
- (b) EU-type examination that is followed by the conformity to type based on internal production control set out in Annex III;
- (c) conformity based on full quality assurance set out in Annex IV.
4. Where, in assessing the compliance of radio equipment with the essential requirements set out in Article 3(2) and (3), the manufacturer has not applied or has applied only in part harmonised standards the references of which have been published in the Official Journal of the European Union, or where such harmonised standards do not exist, radio equipment shall be submitted with regard to those essential requirements to either of the following procedures:
- (a) EU-type examination that is followed by the conformity to type based on internal production control set out in Annex III;
- (b) conformity based on full quality assurance set out in Annex IV.
Article 18 — EU declaration of conformity
Verbatim from EUR-Lex (Directive 2014/53/EU (RED) 02014L0053-20260530), via the Publications Office Cellar API.
1. The EU declaration of conformity shall state that the fulfilment of the essential requirements set out in Article 3 has been demonstrated.
2. The EU declaration of conformity shall have the model structure set out in Annex VI, shall contain the elements set out in that Annex and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the radio equipment is placed or made available on the market.
The simplified EU declaration of conformity referred to in Article 10(9) shall contain the elements set out in Annex VII and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the radio equipment is placed or made available on the market. The full text of the EU declaration of conformity shall be available at the internet address referred to in the simplified EU declaration of conformity, in a language or languages required by the Member State in which the radio equipment is placed or made available on the market.
3. Where radio equipment is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall contain the identification of the Union acts concerned including their publication references.
4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the radio equipment with the requirements laid down in this Directive.
Article 19 — General principles of the CE marking
Verbatim from EUR-Lex (Directive 2014/53/EU (RED) 02014L0053-20260530), via the Publications Office Cellar API.
1. The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
2. On account of the nature of radio equipment, the height of the CE marking affixed to radio equipment may be lower than 5 mm, provided that it remains visible and legible.
Article 20 — Rules and conditions for affixing the CE marking and the identification number of the notified body
Verbatim from EUR-Lex (Directive 2014/53/EU (RED) 02014L0053-20260530), via the Publications Office Cellar API.
1. The CE marking shall be affixed visibly, legibly and indelibly to the radio equipment or to its data plate, unless that is not possible or not warranted on account of the nature of radio equipment. The CE marking shall also be affixed visibly and legibly to the packaging.
3. The CE marking shall be followed by the identification number of the notified body where the conformity assessment procedure set out in Annex IV is applied.
The identification number of the notified body shall have the same height as the CE marking.
The identification number of the notified body shall be affixed by the notified body itself or, under its instructions, by the manufacturer or his authorised representative.
4. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.
ANNEX II — CONFORMITY ASSESSMENT MODULE A
Verbatim from EUR-Lex (Directive 2014/53/EU (RED) 02014L0053-20260530), via the Publications Office Cellar API.
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.
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.
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.
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 VII — SIMPLIFIED EU DECLARATION OF CONFORMITY
Verbatim from EUR-Lex (Directive 2014/53/EU (RED) 02014L0053-20260530), via the Publications Office Cellar API.
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:
Sources
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