EU Declaration of Conformity – MDR IVDR

The MDR/IVDR introduces explicit instructions for the content of the Declaration of Conformity (DoC), unlike the previous Directives. The relevant sections are MDR Article 19 & Annex IV and IVDR Article 17 & Annex IV.

The minimum required information in the DoC includes:

Economic Operators:

• Manufacturer's name and address, including registered trade name or trademark

• Authorized Representative's name and address

• Single Registration Number (SRN) for the manufacturer and authorized representative, if available

• Basic UDI-DI*

Product information:

• Product name and trade name

• Product code(s), catalogue number(s), or other unambiguous references** for identifying and tracing the devices covered by the DoC

• Intended purpose

Notified Body information, if applicable:

• Name and identification number

• Identification of the issued certificate(s)

• Description of the performed conformity assessment procedure

• Device risk classification

• Conformity assessment route

• References to any applicable common specifications for the device

Statements:

• Declaration that the "EU declaration of conformity is issued under the sole responsibility of the manufacturer"

• Confirmation that the device in the DoC complies with the MDR/IVDR and, if applicable, with other relevant EU legislation that requires a DoC (e.g., RoHS)

Additional Information:

• Additional information may be included, such as voluntary harmonized standards, which indicate compliance when used by the device/manufacturer

Signatures:

• Place and date of issuing the Declaration

• Name and function of the person who signed it, along with an indication of, and on behalf of whom, the person signed

• Signature

Additional Requirements:

• Continuously update the DoC as necessary

• Translate the DoC into an official EU national language or languages required by the Member State(s) where the device is available

• If the device is subject to other legislation requiring a DoC, a single DoC should include all the necessary information to identify the relevant Union legislation (e.g., RoHS 2002/95/EC)

* A DoC may contain more than one Basic UDI-DI.

** Except for the product name/trade name, the information allowing identification and traceability may be provided through the Basic UDI-DI.