In this video the most important aspects of the new European Union Medical Device Regulation, the MDR, are given.

 

Transcript:

 

In this video, I would like to highlight the most important aspects of the new European Union Medical Device Regulation, the MDR.
The key changes include:
  1. Product scope expansion
  2. Implementation of the unique device identification (UDI)
  3. Rigorous post-market oversight
  4. Identification of the person responsible for regulatory compliance (PRRC)
  5. Common specifications
  6. Reclassification of devices according to risk, contact duration, and invasiveness
  7. More rigorous clinical evidence for class III and implantable medical devices
  8. Systematic clinical evaluation of Class II a and Class II b medical devices
  9. And lastly, no “grandfathering” provisions

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