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MDCG 2020-3 Rev. 1: Updates to MDR Signifcant Changes Guidance
16 May 2023Overview
Team Notified Body (NB) released a confirmation letter that can be used to show:
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- Proof of valid CE Marking per Regulation 2023/607 (legislation extending the MDR transition period), if:
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- The MDD/AIMDD certificate expired before 20 March 2023 but still met the requirements; and/or
- The manufacturer has lodged a formal application, and has a signed agreement in place, with the Notified Body.
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- Proof of valid CE Marking per Regulation 2023/607 (legislation extending the MDR transition period), if:
The template is available on Team NB’s website: HERE
It is also available on the EU Commission’s website: HERE
How to Use the Template
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.
New Update: “Self-Declaration” Letter Template for Manufacturers
A new template letter is available: HERE
It is for manufacturers to self-declare their legacy device meets the requirements under Regulation 2023/607.
