Dear members, please find this Team NB Position Paper regarding the EC Annex VII – Commission Implementing Regulation Draft.
This is in response to the European Commission proposed draft Implementing Regulation EUR-Lex – Ares(2025)11081575 – EN – EUR-Lex
The EC implementing regulation is aimed at making changes within the current MDR/IVDR framework, to reduce administrative burden and streamline the process of the MDR/IVDR. This is ahead of any further proposed changes that would more widely change the MDR/IVDR.
