In this video the most important aspects of the new European Union Medical Device Regulation, the MDR, are given.
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:
Product scope expansion
Implementation of the unique device identification (UDI)
Rigorous post-market oversight
Identification of the person responsible for regulatory compliance (PRRC)
Reclassification of devices according to risk, contact duration, and invasiveness
More rigorous clinical evidence for class III and implantable medical devices
Systematic clinical evaluation of Class II a and Class II b medical devices
And lastly, no “grandfathering” provisions