Chapter VII, conformity of products and CE marking
Article 16: EU declaration of conformity of products
The declaration must state that the applicable requirements are demonstrated, name any Article 14 exception, follow the Annex III model and be kept up to date and translated.
- Citation
- Article 16, CELEX 32019L0882 (Directive)
- Binds
- Manufacturers of in-scope products, and any authorised representative acting under the mandate.
- In the instrument
- Chapter VII, conformity of products and CE marking
- Applies from
- 28 June 2025 for products placed and services provided from that date (Article 31(2)). The Article 4(8) 112 duty may be deferred to 28 June 2027 where a member state uses Article 31(3).
- Source
- EUR-Lex, CELEX 32019L0882
What it requires
Paragraph 1 sets the content of the statement. The declaration must confirm that the applicable requirements have been shown to be met. Where Article 14 has been used, it must name the requirements covered by the exception.
Paragraph 2 sets the form. The declaration follows the model structure in Annex III to Decision No 768/2008/EC, contains the elements listed in Annex IV to this Directive, and is continuously updated. The technical documentation requirements must avoid imposing an undue burden on microenterprises and SMEs, and the declaration must be translated into whichever language or languages that member state requires.
Paragraph 3 allows one declaration where a product is subject to several Union acts requiring one, provided it identifies each act and its publication reference. Paragraph 4 makes the legal effect explicit: by drawing up the declaration, the manufacturer assumes responsibility for compliance.
In practice
Version the declaration and keep every version. Each version should name the model, the standards applied, the requirements covered by an Article 14 exception and the language of issue. When a product changes, issue a new version rather than editing the old file, because the retention duty is tied to the placing on the market of that model.
What to do
- Draft the declaration on the Annex III model and include the Annex IV elements.
- Name each requirement covered by an Article 14 exception.
- Update the declaration whenever the product or the applicable requirements change.
- Translate it into the language required in each member state of supply.
- Combine declarations where several Union acts apply, listing each act.
Evidence to keep
- The signed declaration with its version and date.
- The cross-reference from each declaration statement to the technical file.
- The translation record per member state.
- The list of other Union acts covered by a combined declaration.
Dates
- 2025-06-28A declaration is needed for products placed from this date. (Article 2(1), Article 7(2))
Cross-references
Where teams get this wrong
A declaration that claims full conformity while an Article 14 exception is in use is inaccurate. The exception must be named, and the named requirements must match the assessment file.
Read from the Official Journal text of Directive (EU) 2019/882, OJ L 151/70, 7 June 2019, Article 16. Check it yourself: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32019L0882. This page states the provision in our own words and is not legal advice; it does not certify any product or service.