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EU Commission: Validity of MDR is to be postponed by one year - decision by Council and Parliament expected

In view of the Corona crisis, the European Commission has announced on 3 April 2020 that it will postpone the validity of the Medical Devices Regulation (Regulation (EU) 2017/745 = MDR) by one year.

A suspension of the start of validity for one year would give European medical device manufacturers and third-country manufacturers considerably more time to prepare themselves further for the numerous requirements of the MDR. In addition, more and more manufacturers had already reported that due to the Corona crisis, suppliers and contract manufacturers were already being eliminated, audits by notified bodies were not taking place, and internal company priorities had also had to be directed towards dealing with the Corona crisis and supporting hospitals with urgently needed products.

The postponement of the start of validity is therefore a pragmatic and sensible reaction to the currently very tense situation. However, the German Association of Medical Device Manufacturers (BVMed) critizises that only the validity of the MDR as such is postponed, but the transitional periods provided for in the MDR are not extended. Although it is to be welcomed that the Commission - even after intensive lobbying by BVMed - supports the project, it would indeed be more helpful if also the transitional periods would be prolonged respectively. The postponement would be an important signal for patient care and the medtech companies.

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