One of the novelties of the new Regulation 2017/745 concerns the EU Declaration of Conformity which must accompany each Medical Device. Here are the requirements for its validity.
The EU Declaration of Conformity is the indispensable document for the CE marking, with which the manufacturers’ fulfillment of the Regulation is declared and guaranteed.
The 10 validity requirements are defined in Annex IV of the Medical Device Regulation:
- The name, registered trade name or registered trade mark and the address of the manufacturer or authorized representative.
- A statement that the declaration is issued under the sole responsibility of the manufacturer..
- The alphanumeric code UDI-DI that identifies the product.
- Information that describes the product and allows its traceability, such as name, trade name, product code or other references that may be included, such as images and photographs.
- The risk class of the device according to the MDR.
- The statement of compliance with the regulation, and possibly with any other Union legislative act aimed at issuing the declaration of conformity.
- All relevant Union harmonization legislation, reference standards or other technical specifications (such as national standards and technical specifications) in a precise, complete and clearly defined manner; this implies that the version and/or date of the relevant standard is specified.
- The name and identification number of the Notified Body eventually involved, the description of the conformity assessment procedure and the reference to the relevant certificate (not relevant for Class I DM).
- Any additional information that may be required (for example, class IIR surgical masks).
- The place and date of issue of the declaration (prior to May 26, 2021 to take advantage of the transitional period of article 120) signature and title or an equivalent trademark of the authorized person.
The declaration must be translated into the official language of the Member State in which the medical device is marketed and must be constantly updated.