MDR transition period - extension letter: practical questions

DannyVerbiest said:

Hi,
I am having a few practical questions concerning the MDR and IVDR transition periods.

1) A MDD manufacturer is able to provide a self declaration to extend its certificate in case it complies to the requirements outlined in the MDR. (MDR compliant QMS and PMS and MDR agreement with NB,..)
--> Question: what happens if the MDD certificate expires before or during the transition period? Will the NB still issue a new MDD certificate or is the extension letter sufficient to release and sell CE-marked products?

2) Question: Can an IVDD manufacturer also self declare extension if it complies to the IVDR transition requirements? I cannot seem to get this confirmed?

Thanks in advance for the help!

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Sinus Tarsi said:

Hello,
Our CE cert has expired and the extension letter by our notified body has been sufficient to continue marketing in the EU.

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Sinus Tarsi said:

Hello,
Our CE cert has expired and the extension letter by our notified body has been sufficient to continue marketing in the EU.

Click to expand...

DannyVerbiest said:

Thanks for the quick reply! Did you receive the extension letter (or confirmation letter) of your NB before or after the certificate was expired?

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