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Declaration of conformity for medical devices

Updated: Jun 19, 2023

The Declaration of Conformity (also known as DoC) is a critical document for every medical device in Europe. 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.

Important contents of the declaration of conformity

The MDR specifies in which information must definitely be part of the declaration of conformity (DoC). 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 EU declaration of conformity up to date.

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

  • 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.

Who can issue it?

We are able to provide the Declaration of Conformity (DoC) for your medical devices!

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