After successful conformity assessment, the manufacturer draws up an EU declaration of conformity. By doing so, the manufacturer assumes responsibility for the product’s compliance with the CRA. The declaration must be kept up to date and made available in the languages required by the Member State where the product is placed or made available on the market.
Minimum Annex V content
The EU declaration of conformity contains at least:
- product name and type and information enabling unique identification;
- the name and address of the manufacturer or authorised representative;
- a statement that it is issued under the sole responsibility of the provider identified in Annex V;
- an identifiable, traceable object of the declaration, optionally with a photograph;
- a statement that the object complies with the relevant Union harmonisation legislation;
- references to relevant harmonised standards, common specifications or cybersecurity certification used;
- where applicable, the notified body’s name and number, the procedure performed and the certificate identifier; and
- place and date of issue, and the authorised person’s name, function and signature.
Where more than one EU legal act requires an EU declaration for the product, draw up a single declaration covering them all and include their titles and publication references.
Full or simplified declaration with the product
The manufacturer must accompany the product information and instructions with either the full declaration or the simplified Annex VI declaration. The simplified declaration must give the exact web address where the full text is available. Keep the full text available at that address for the support period.
Keep the technical documentation and EU declaration available to market-surveillance authorities for at least 10 years after the product is placed on the market or for the support period, whichever is longer.