EU declaration of conformity

The manufacturer’s declaration of conformity states that the requirements in the regulation are fulfilled for the device.

In addition, if the device is subject to other Union legislation which requires a declaration of conformity, a single EU declaration must be established for all Union acts applicable to the device.

The EU declaration of conformity must include:

1. Name, registered trade name or registered trade mark and, if already issued, a single registration number (SRN) of the manufacturer, and, if applicable, its authorised representative and the address of their registered place of business where they can be contacted and physically located.
2. A statement that the EU declaration of conformity was issued under the sole responsibility of the manufacturer.
3. The basic UDI‍-‍DI.
4. Product and trade name, product code, catalogue number or other unambiguous reference allowing identification and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate, as well as its intended purpose. Except for the product or trade name, the information which enables identification and traceability may be provided through the basic UDI‍-‍DI.
5. The risk class of the device.
6. A statement that the device that is covered by the present declaration is in conformity with this Regulation and, if applicable, with any other relevant Union legislation which contains provisions concerning the issuing of an EU declaration of conformity.
7. References to common specifications used and with respect to which conformity is declared.
8. Where applicable, the name and identification number of the notified body, a description of the conformity assessment procedure performed and identification of the certificate(s) issued.
9. Where applicable, additional information.
10. Place and date of issue of the declaration, name and position of the person who signed it, as well as information on whose behalf the person signed the declaration, and a signature.

Involvement of a notified body

Before CE marking, the manufacturer must in many cases involve an independent third party to review the medical device’s documentation and issue a certificate before it may be placed on the market.

Manufacturers of devices in risk classes IIa, IIb and III must involve a notified body, an independent third party, which performs an assessment of the documentation and issues a certificate prior to CE marking. Manufacturers of in vitro diagnostic devices (IVDs) in risk classes B, C and D will also need a notified body.

More devices are covered by the new regulations

Please note that even some devices which according to the directive‍-‍based legislation (MDD) are in class I, will, in accordance with the MDR, need to be reviewed and have a certificate issued by a notified body before they can be placed on the market. An amendment to the MDR has meant that such products may be placed on the market in accordance with the requirements of the MDD until 25 May 2024.

Reusable surgical instruments

Manufacturers of reusable surgical instruments must consult a notified body for a review of aspects which relate to reuse of the device, particularly cleaning, disinfection, sterilisation, maintenance and functional testing and the associated instructions for use.
More information is available in Section 2.3 of Annex VIII to the MDR.

Substances

Devices that are composed of substances or combinations of substances which are introduced into the human body via a body orifice or applied to the skin will belong to risk classes higher than class I, and manufacturers of such devices therefore need to involvea notified body. Many such devices are currently CE marked as class I devices.
More information is available in Rule 21 of Annex VIII to the MDR.

Software

Software that provides information which is used to take decisions for diagnosis or therapeutic purposes will, in accordance with a new rule, belong to one of the higher risk classes IIa, IIb and III. This means that the manufacturer must involve a notified body.
More information is available in Rule 11 of Annex VIII to the MDR.