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New amending document for EU MDR 2017/745: the EU 2023/2197

Medical devices regulation

📣 New amending document for EU MDR 2017/745: the EU 2023/2197 

It concerns assignment of Unique Device Identifiers for contact lenses

It shall apply from 9 November 2025. However, manufacturers may already before that date assign a Master UDI-DI in accordance with Regulation (EU) 2017/745 as amended by this Regulation.

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Since the arrival of Regulation 2017/745, new requirements are requested and form part of the documentation to be presented to the notified body (e.g. UDI, review of the in-depth clinical evaluation, PMS procedure, QC results from validation products, proof of staff skills, etc.).

CSDmed brings its expertise and a methodical approach to its clients, start-ups, manufacturers, importers and distributors of medical devices, thanks to a team of specialized experts and consultants, who will be able to address the MDR transition in its entirety

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