R&Q clients have one more thing to be thankful for this year as a new Corrigenda to the European Union Medical Device Regulation (MDR) has been issued that extends the due date for Certificates for Class I – reusable surgical instruments – for four years. Check out the newly released document here (English translation begins on page 44).
The key message from this document is that if Notified Body involvement is required for a Class I device and the device is on a Declaration of Conformity by May 26, 2020, then it can remain on the market under certain conditions until May 26, 2024. Other Class I devices that have a Notified Body certificate (sterile or measuring) may remain on the market if they have a valid certificate from a Notified Body.
In order to take advantage of this extension, the devices must meet the following conditions:
1. Must be on the Declaration of Conformity by May 26, 2020 for the Medical Devices Directive (MDD)
2. Must continue to meet the requirements of the MDD
3. No significant changes in design
4. No significant change in the intended purpose
5. Must follow EU Medical Device Regulation (MDR) post-market surveillance (PMS), vigilance and registration
a. Note that starting on May 26, 2020, registration is affected by the European database on medical devices (EUDAMED) delay until May 26, 2022
Keep in mind that the corrigenda has a limited scope and does not extend other deadlines!
R&Q experts will continue to keep an eye on this breaking news and provide updates on our blog as we learn more.
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