EU Declaration of Conformity for MDD-AIMDD-IVDD

The Declaration of Conformity (DoC) for MDD/AIMDD/IVDD is not explicitly outlined in the Directives. Instead, manufacturers must derive the requirements from the Directives and refer to Council Decision 768/2008/EC. The Blue Guide provides additional guidance on the minimum expectations.

The MDD/AIMDD/IVDD DoC should include, at a minimum, the following information:

• Manufacturer name and address

• Authorized Representative name and address

• Notified Body name and number

• Product information:

- Product Name

- Product identification for traceability

- Device classification

- Conformity assessment route

- References to relevant harmonized standards or technical specifications used

• Statements:

- The DoC is issued under the sole responsibility of the manufacturer

- The product is in conformity with the relevant legislation (e.g., Council Directive 93/42/EEC)

• Signatures:

- Name & title

- Date and place of issue

- Signed for and on behalf of: ………….

- Signature

Additional Considerations:

The Blue Guide suggests the following for the DoC:

• Continual updating as changes occur

• Translation into the language(s) required by the Member State where the product is placed or made available on the market

• Combining multiple legislations into a single DoC when applicable

It is important to note that the Blue Guide serves as a valuable reference for interpreting European legislation, but only the text of the Union harmonization act itself has legal force.

Special Considerations for Legacy Devices:

Legacy devices are those permitted to be placed on the European market under MDD/AIMD/IVDD CE Marking after the dates of application for MDR/IVDR have passed.

To qualify as a legacy device, it must have been CE marked with a DoC drawn up and signed before May 26, 2021 (MDR) or May 26, 2022 (IVDR).

To maintain its status as a legacy device, no significant changes can be made to the design or intended purpose. Otherwise, the device may need to comply with the new Regulation. However, non-significant changes, such as modifications to the manufacturer's name or address, are permissible.

DoCs should be updated to reflect new information. While EU legacy device guidance documents do not provide specific instructions for updating the DoC, they do state that necessary amendments/updates to the technical information should be done transparently.

MDCG 2022-6, which offers guidance on significant changes to IVD legacy devices, addresses how Notified Bodies should handle non-significant changes. According to the document:

"After reviewing the manufacturer's description of the (proposed) change, the notified body that issued the certificate in accordance with the IVDD may confirm in writing that the implementation of the change does not represent a significant change in design or intended purpose under IVDR Article 110(3). This confirmation ensures the validity of the related IVDD certificate after the date of application of the IVDR, up until its expiry date or May 26, 2025, whichever comes first."

The same logic can be applied to the DoC. In other words, the manufacturer can issue a written statement declaring the change and affirming that it does not constitute a significant alteration to the design or intended use. This statement should be signed, dated, and appended to the DoC.