Friday, December 9, 2022

The 5 most relevant changes the Medical Device Regulation MDR introduces, that you must know


The Medical Device Regulation MDR replaces both, the Medical Device Directive (MDD, 93/42/EEC) and the Directive for Active Implantable Medical Devices (AIMDD).

This video gives an overview on the 5 most relevant changes the MDR introduces. These changes include

1. Conformity assessment procedures
2. Classification
3. Essential requirements – General safety and performance requirements
4. UDI & EUDAMED
5. Post-Market requirements

The Johner Institute helps medical device manufacturers to fast and easily navigate the approval processes, to fulfill the MDR requirements and to obtain the CE mark.

Complimentary consulting on www.johner-institute.com.



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