Although the IVDR will still fully apply from 26 May 2022, the European Commission proposed additional transition periods to avoid any significant disruption in the supply of IVD medical devices. Note that the requirements remain the same.
The lack of notified body means that the availability of products cannot be ensured in time, and that is why the European Commission proposes these new deadlines:
| Risk Class | New deadline |
| Class B and A sterile | May 2027 |
| Class C | May 2026 |
| Class D | May 2025 |
Moreover, medical devices with a certificate issued by a notified body before 26 May 2022 and in accordance with the Directive must meet the Regulation requirements by 26 May 2025 (one year more than originally planned).
In view of the difficulties in finding a notified body these days, it is highly recommended to start the application process very early.
Check here the official ressources published by the EC regarding this news:
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