Despite repeated statements that the IVDR deadline of 26 May 2022 would not be extended, that is precisely what the European Commission has just done.
Whilst just a proposal at the moment, ratification by the European Parliament and Council is just a formality and formal adoption by publication in the Official Journal of the European Union will follow.Issue with the IVDR Transition Deadline Extension
The problem with the current IVDR deadline is two-fold: 1) Six notified bodies have been designated (approved) to date with just 11 applications pending and 2) About 80% of IVDRs previously designated as Class A (self-declaration) have been reclassified as Class B (notified) [where all the bodies that justify this reclassification is a mystery especially when the FDA presently have the opposite policy].This is not a Blanket Extension
What’s proposed is not a blanket extension to May 2027 but is a more graded approach. This is summarised in the table below.
Summary of IVDR Transition Deadlines |
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|
IVDR Class |
Deadline | CE Mark by |
|
Class D |
May 2025 | Notified Body |
|
Class C |
May 2026 | Notified Body |
|
Class B |
May 2027 | Notified Body |
|
Class A sterile |
May 2027 | Notified Body |
|
Class A non-sterile |
May 2022 | Self-declaration |
| All New IVDRs * | May 2022 |
Notified Body |
(*) (*) .(*) other than Class A non-sterile, which continue as self-declaration.
Class B device manufacturers, most of whom will not have had need of a Notified Body previously, should not delay in seeking one out. They are not going to be easy to find despite the 5-year postponement.
The IVDR Deadline has not been postponed
Note carefully that the postponement refers solely to the production of Certificates of Conformity for CE Marks. The IVD Regulations themselves will otherwise apply in full from 26th May 2022.
Requirements for Vigilance and Market Surveillance may prove challenging for those manufacturers currently in the self-declared space.The EUDAMED Database has to be populated also
And then there’s the introduction of the EUDAMED database of three modules:1. Actors registration,
2. UDI/Devices registration and
3. Notified Bodies and Certificates.
The deadline for the other 3 modules remains 26th June 2022 (same as for IVDR). These latter three are:4. Clinical investigations and performance studies,
5. Vigilance and post-market surveillance and
6. Market Surveillance.
It is anticipated that manufacturers without a dedicated Regulatory Affairs resource will struggle and for some, it is already too late regarding clinical investigations and performance studies.