EU - Medical Devices Documents

1. European Commission -EU- Medical Devices legislation

- New regulations - HERE

- EU-Legislation - Regulatory framework - HERE

- MDCG 2023-2 - List of Standard Fees - January 2023 - HERE

- New Approach Notified and Designated Organisations (NANDO) - HERE

2. WHO - Medical Devices - HERE

3. EMA/CAT and Medical Devices Notified Body (EMA/CAT-NB) Collaboration Group - HERE

4. Medical Device Manufacturers Association - HERE 

5. FDA – U.S. Food and Drug Administration - HERE

- Classify Your Medical Device – HERE