Medical Device Regulatory Guide

View Original

Team NB MDR transition times and NB capacity

Key Takeaways:

1️⃣ MDCG 2022-14 shows progress, but tasks remain.

2️⃣ Clear guidance is needed for efficient MDR certification.

3️⃣ Notified bodies are standardizing procedures; a technical secretariat could help.

4️⃣ Swift designation of new bodies can smooth transitions.

5️⃣ Reducing new MDCG requirements can free up resources.

6️⃣ MDR increases demand for experts; simplifying requirements can help.

7️⃣ Alternative methods to showcase skills can expand body capacity.

 

🔗 Original:  https://www.team-nb.org/wp-content/uploads/2023/08/Team-NB-PositionPaper-MDRTransitionTimelines-NotifiedBodyCapacity-V1.pdf