Thursday, March 28, 2024

Tag Archives: essential requirements

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 […]

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