Team- NB Notified Body Confirmation Letter – EU 2023/607

Written By MDRG

#Team-NB have created a useful template for Notified Bodies regarding the EU 2023/607 transition provision. It includes:

 

🔹 Evidence of valid CE Marking in accordance with Regulation 2023/607, applicable if the MDD/AIMDD certificate expired prior to 20 March 2023 but still fulfilled the necessary criteria.

🔹 The manufacturer has submitted a formal application as stipulated in the first paragraph of Annex VII under MDR Section 4.3, and a binding agreement has been established with the Notified Body as per the second subparagraph of Annex VII under MDR Section 4.3.

 

🔗 Original Document :  https://www.team-nb.org/notified-body-confirmation-letter-eu-2023-607/

MDRG
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