EU Declaration of Conformity – MDD/AIMDD/IVDD
The Directives do not explicitly outline the minimum requirements of the Declaration of Conformity. Instead, manufacturers must extrapolate requirements from the Directives and refer to Council Decision 768/2008/EC. The Blue Guide* is also useful to understand minimum expectations.
At minimum, the DoC should contain:
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- Manufacturer name and address
- Authorized Representative name and address
- Notified Body name and number
- Product information:
- Product Name
- Product identification, allowing traceability
- Device classification
- Conformity assessment route
- References to relevant harmonized standards used or other technical specifications
- Statements:
- That the DoC is issued under the sole responsibility of the manufacturer
- That the product is in conformity with the relevant legislation (e.g., Council Directive 93/42/EEC)
- Signatory:
- Name & title
- Date and place of issue
- Signed for and on behalf of: ………….
- Signature
Additional Considerations
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- Blue Guide recommends the DoC:
- Should be continually updated as changed
- Be translated into the language or languages required by the Member State in which the product is placed or made available on the market
- A single DoC is required whenever a product is covered by several pieces of union harmonization legislation requiring an EU DoC
- Note, Council Directive 768/2008/EC also states that where multiple legislations apply to a device which require a DoC, they should be combined into a single DoC
*The Blue Guide “is intended purely as a guidance document – only the text of the Union harmonization act itself has legal force.” However, it still remains a valuable reference in interpreting European legislation.
Special Considerations for Legacy Devices
Legacy devices are those that are legally allowed to be placed onto the European market under the under MDD/AIMD/IVDD CE Marking, after the MDR/IVDR dates of application have passed.
To qualify as a legacy device, it must have been CE marked, with a DoC drawn up and signed, before the 26 May 2021 (MDR) or 26 May 2022 (IVDR).
To remain 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 can be made. For example, changes to the manufacturer’s name or address.
DoCs should be updated to reflect new information. However, while EU legacy device guidance documents do state that “necessary amendments/updates to the technical information should be done in a transparent manner“, they do not address specifically how to account for updates to the DoC.
MDCG 2022-6, guidance on significant changes to IVD legacy devices, does address how Notified Bodies should account for non-significant changes, since the IVDD CE Marking certificate should not be amended. It states that:
“…the notified body that issued the certificate in accordance with the IVDD may confirm in writing, after having reviewed the manufacturer’s description of the (proposed) change, that the implementation of the change does not represent a significant change in design or intended purpose under IVDR Article 110(3) and that the related IVDD certificate remains valid after the date of application of the IVDR, but no longer than its expiry date or 26 May 2025, whichever comes first.
Such written confirmation corrects or complements information on an existing certificate but does not represent the issuance of a ‘supplemented certificate’, since this is prohibited as mentioned in Section 3. In case of requests from authorities, the manufacturer should number such letters received from the notified body and submit them together with the certificate.”
It is reasonable to apply the same logic to the DoC. i.e., the manufacturer could issue a written statement of the change, and that it does not represent a significant change to the design or intended use. That statement could be signed, dated and appended to the DoC.
For more information, please read: What are Legacy Devices?