State of the art GSPR

Michael M. Kania
August 10, 2020
Medical Device Regulation

State of the art is a requirement of the EU-MDR. To create and maintain good GSPR (General Safety and Performance Requirements), you have to say goodbye to the old world. Harmonized standards, which were still used under the MDD, may no longer be used simply to show compliance with the MDR.

Manufacturers have partially rested on these standards. Now the notified bodies would like to know more about it. Is the relevant standard fully or only partially applicable? If not, why not. If so, which parts of it and which issue status. Of course, the complete verification documents must also be available. In the latest version. In this video we show you the steps that have to be taken to make the leap from MDD to MDR with regard to Annex I.

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