The EU declaration of conformity referred to in Article 28, shall contain all of the following information:
How to satisfy it: The artifact that actually ships. Article 28 requires it, Annex VII (7) requires a copy inside the technical file, and three module endpoints each end by drawing one up: Annex VIII Part I (4) for module A, Part III (3) for module C and Part IV (5) for module H. Article 13(20) allows a simplified form, set out in Annex VI, provided the full text is reachable at a stated address.
A statement that the EU declaration of conformity is issued under the sole responsibility of the provider
How to satisfy it: Reads 'the provider', not 'the manufacturer'. That is the Official Journal wording and is reproduced verbatim here rather than corrected. Everywhere else in the Regulation the duty holder for the declaration is the manufacturer, per Article 28 and Article 13.
Object of the declaration (identification of the product with digital elements allowing traceability, which may include a photograph, where appropriate)
A statement that the object of the declaration described above is in conformity with the relevant Union harmonisation legislation
How to satisfy it: Conformity is declared against the relevant Union harmonisation legislation, plural. A connected product frequently sits under several regimes at once, and a single declaration may have to cover them together rather than one per instrument.
References to any relevant harmonised standards used or any other common specification or cybersecurity certification in relation to which conformity is declared
How to satisfy it: The same standards vacuum that shapes the whole file. With no CRA harmonised standard cited in the Official Journal as of 13 Aug 2026, this field currently points at common specifications, a certification scheme, or nothing at all.
Where applicable, the name and number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate issued
How to satisfy it: Only where a notified body was involved, so it is empty for module A and populated for the module B, C and H routes. Its presence or absence is the fastest read of which conformity route a manufacturer actually took.
Additional information: Signed for and on behalf of: (place and date of issue): (name, function) (signature):
How to satisfy it: The signature block is part of the required form, not decoration: place and date of issue, name and function of the signatory, and the signature itself. It is what turns the document into an attributable declaration rather than a description.
Every quoted requirement on this page is verbatim Official Journal text. The surrounding guidance is Legalithm’s commentary and is not regulation. This page states the obligation and its legal basis; it is not legal advice, and the corpus has not been reviewed by counsel.
