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:
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
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
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 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
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.