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EU declaration of conformity and CE marking
The product conformity machinery: the EU declaration of conformity, the CE marking rules, and the Annex IV internal production control procedure manufacturers follow.
Article 16 — EU declaration of conformity of products
Verbatim from EUR-Lex (Directive (EU) 2019/882, OJ text 32019L0882), via the Publications Office Cellar API.
1. The EU declaration of conformity shall state that the fulfilment of the applicable accessibility requirements has been demonstrated. Where as an exception, Article 14 has been used, the EU declaration of conformity shall state which accessibility requirements are subject to that exception.
2. The EU declaration of conformity shall have the model structure set out in Annex III to Decision No 768/2008/EC. It shall contain the elements specified in Annex IV to this Directive and shall be continuously updated. The requirements concerning the technical documentation shall avoid imposing any undue burden for microenterprises and SMEs. It shall be translated into the language or languages required by the Member State in which the product is placed or made available on the market.
3. Where a product 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 acts concerned including the publication references.
4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the product with the requirements of this Directive.
Article 17 — General principles of the CE marking of products
Verbatim from EUR-Lex (Directive (EU) 2019/882, OJ text 32019L0882), via the Publications Office Cellar API.
The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.
Article 18 — Rules and conditions for affixing the CE marking
Verbatim from EUR-Lex (Directive (EU) 2019/882, OJ text 32019L0882), via the Publications Office Cellar API.
1. The CE marking shall be affixed visibly, legibly and indelibly to the product or to its data plate. Where that is not possible, or not warranted, on account of the nature of the product, it shall be affixed to the packaging and to the accompanying documents.
3. 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 IV — CONFORMITY ASSESSMENT PROCEDURE – PRODUCTS
Verbatim from EUR-Lex (Directive (EU) 2019/882, OJ text 32019L0882), via the Publications Office Cellar API.
1. Internal production control
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 its sole responsibility that the product concerned satisfy the appropriate requirements of this Directive.
2. Technical documentation
The manufacturer shall establish the technical documentation. The technical documentation shall make it possible to assess the conformity of the product to the relevant accessibility requirements referred to in Article 4 and, in case the manufacturer relied on Article 14, to demonstrate that relevant accessibility requirements would introduce a fundamental alteration or impose a disproportionate burden. The technical documentation shall specify only the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the product.
The technical documentation shall, wherever applicable, contain at least the following elements:
- (b) a list of the harmonised standards and technical specifications the references of which have been published in the Official Journal of the European Union, applied in full or in part, and descriptions of the solutions adopted to meet the relevant accessibility requirements referred to in Article 4 where those harmonised standards or technical specifications have not been applied; in the event of partly applied harmonised standards or technical specifications, the technical documentation shall specify the parts which have been applied.
3. Manufacturing
The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the products with the technical documentation referred to in point 2 of this Annex and with the accessibility requirements of this Directive.
4. CE marking and EU declaration of conformity
- 4.1. The manufacturer shall affix the CE marking referred to in this Directive to each individual product that satisfies the applicable requirements of this Directive.
- 4.2. The manufacturer shall draw up a written EU declaration of conformity for a product model. The EU declaration of conformity shall identify the product 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.
5. Authorised representative
The manufacturer’s obligations set out in point 4 may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that they are specified in the mandate.
Sources
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All text above is reproduced verbatim from the EUR-Lex OJ text of Directive (EU) 2019/882 (CELEX 32019L0882; the three corrigenda concern the German, Estonian and Finnish versions only, so the English OJ text is authoritative), extracted mechanically via the Publications Office Cellar API — see tools/eur-lex/build_eu_eaa.py, whose verify mode confirms every source paragraph appears verbatim. Do not hand-edit article or annex text. Each article/annex carries the official ELI identifier as a trailing attribute anchor (e.g. {#art_4}, {#anx_I}), which also works as a fragment on the EUR-Lex HTML view; paragraphs and points carry derived anchors from the printed labels, with annex anchors additionally carrying a section token because point numbering restarts per section (e.g. {#anx_I-sIII-a}). Printed footnote markers (e.g. "(27)") are reproduced inline; the footnote bodies — OJ citations of referenced acts at the end of the OJ document — are not.