CRA FAQ

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Should the manufacturer draw up separate EU declarations of conformity per Union legal act?

Concerning the drawing up of the EU declaration of conformity by the manufacturer, Article 39(2) of the EHDS Regulation provides for a single EU declaration of conformity to be drawn up in respect of all Union legal acts applicable to the EHR system. That EU declaration of conformity shall contain all the information required for the identification of the Union legal acts to which it relates. The CRA provides the same for products with digital elements in Article 28(3).

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Disclaimer: This document is prepared by the Commission services and should not be considered as representative of the European Commission’s official position. The replies to the FAQs do not extend in any way the rights and obligations deriving from applicable legislation nor introduce any additional requirement. The expressed views are not authoritative and cannot prejudge any future actions the European Commission may take, including potential positions before the Court of Justice of the European Union, which is competent to authoritatively interpret Union law.