For medical devices, the declaration of conformity is an essential document according to the MDR. Based on this declaration, a medical device manufacturer may affix the CE marking to its product. This is also an assurance for physicians, patients, users and third parties that the respective medical device complies with the existing requirements for product safety and performance.

With the declaration of conformity, the manufacturer certifies that the Essential Safety and Performance Requirements from the MDR have been met by the medical device in question. It is one of the manufacturer’s obligations to always keep the declaration of conformity up to date and to be able to show it at any time upon request. Depending on the EU member state in which the medical device is placed on the market, the declaration must also be translated into one (or more) official languages of the EU.

Important contents of the declaration of conformity

The MDR specifies in Annex IV which information must definitely be part of the declaration of conformity. The EU Commission can change this information at any time, taking into account current technical progress. For this reason, too, it is important that manufacturers always keep their declaration up to date.

The following information must be included in every declaration of conformity:

Name and address of the manufacturer or his authorized representative and the SRN (Single Registration Number).

Declaration that the manufacturer is solely responsible for the declaration of conformity.

Basic UDI-DI

Product and trade name, product code, catalog number and other references to allow identification and traceability of the product, the intended use and a picture if applicable.

Product risk class

Assurance that the product complies with the MDR and other applicable EU regulations where a declaration of conformity is required.

References to applied common specifications

If applicable, name and identification number of the notified body, description of the conformity assessment procedure

Additional information if necessary

Place and date of issue, name and function of the signatory, indication for whom and on whose behalf this person has signed and his signature

Why this declaration is important

A medical device cannot be placed on the market without a valid declaration of conformity. It is therefore essential to create the conditions for drawing up this declaration in good time and to include this in the approval process.

Whether you need help with the preparation of this declaration or you already have one and want it to be checked, seleon gmbh is your right contact in any case!

Please note that all details and listings do not claim to be complete, are without guarantee and serve purely as information.