Clifford Chance

The countdown for the MDR is on: 175 days to go - is the German legislator ready yet?

3 December 2019

The Medical Device Regulation (“MDR”) and the In vitro Diagnostic Medical Devices Regulation (“IVDR”) entered into force on 25 May 2017. Without doubt, among the major innovations of the MDR are certainly the stricter regulations with regard to the safety and traceability of medical devices as well as stricter regulations regarding medical devices as software. In addition, the new classification rules for medical devices are definitely among the major changes of the MDR.

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