Medical Device Regulation – final version published

Medical Device Regulation – final version published

The new EU Medical Device Regulation (MDR) and In-vitro-diagnostic Medical Device Regulation (IVDR) have been published in the Official Journal of the European Union.
The new Regulations will enter into force on May 25th, 2017. The new rules will only apply after a transitional period. Namely, the Medical Device Regulation on May 26, 2020 (3 years after entry into force) and the In-vitro-diagnostic Medical Device Regulation om May 26, 2022 (5 years after entry into force).

Downloads (published versions from May 5, 2017):
Medical Device Regulation MDR (English)
In-vitro-diagnostic Medical Device Regulation IVDR (English)

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Michael Wolff

DE