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  • LEGISLATIVE DATABASE
  • WORKSHOP PRESENTATIONS


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 DeviceHERE