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EU Declaration of Conformity – MDR IVDR

Requirements for Declaration of Conformity (DoC) under the MDR/IVDR: Essential Information and Additional Obligations

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


  • 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


  • 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.

EU Declaration of Conformity – MDR IVDR
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