·         Background: Regulation (EU) 2017/746 aims to enhance quality and safety for in vitro diagnostic medical devices.

·         Transition: Staggered periods ensure smooth adaptation and continuous supply of essential devices.

·         Challenges: Complex implementation and COVID-19 impacts have posed significant hurdles.

·         Focus Areas:

·         Strengthening notified body capacity.

·         Streamlining certification processes.

·         Developing and implementing guidance documents.

·         Progress: Achievements include designating notified bodies, developing the Eudamed database, and adopting common specifications.

·         Goal: Collaborative effort to ensure a seamless transition, maintaining high safety and quality standards in the EU market.

🔗 Original:  https://health.ec.europa.eu/document/download/558ede8b-ff9a-4a8f-bb9d-d61e4a515b6a_en