Team Notified Body (NB) released a confirmation letter that can be used to show:
The template is available on Team NB’s website: HERE
It is also available on the EU Commission’s website: HERE
This is not a letter for manufacturers to complete; instead, it is for the Notified Bodies. The Notified Body will add the device and manufacturer-specific information, and issue this on their letterhead.
Therefore, if you require verification of your eligibility for the MDR extension, you should contact your Notified Body and request they issue you a copy of this letter.
Industry has been waiting for this to be issued, since the EU Commission’s Q&A document on Regulation 2023/607 stated that the Notified Body could issue a confirmation letter helping to confirm the continued validity of the MDD/AIMDD certificate. Further, it stated that it could be issued “without extra costs”. That said, we understand several Notified Bodies are charging admin fees to issue the letter. Please check directly with your Notified Body.
The Q&A document also mentioned manufacturers could issue a self-declaration letter to help verify their devices’ validity under the MDR extension. And that it “could be based on a harmonized template”. Therefore, we presume a self-declaration template letter is also in the process of being drafted. Casus will report as soon as it is available.
A new template letter is available: HERE
It is for manufacturers to self-declare their legacy device meets the requirements under Regulation 2023/607.