European Commission: Postponement of the effective date of the Medical Device Regulation
The European Commission has accepted the proposal to postpone the application of the new Medical Device Regulation (EU MDR 2017/745) until May 26, 2021. This is stated in a press release dated 03.04.2020.
The availability of indispensable medical devices in the coronavirus pandemic has priority, according to the justification. Originally, the regulations of the Medical Devices Ordinance, which had already come into force on 25 May 2017, were to come into force on 26 May 2020. Above all, the regulation lays down uniform and more stringent criteria for so-called Notified Bodies in the context of the approval of medical devices and also regulates the procedure for the approval of clinical trials of medical devices. To the press release of the EU Commission: https://ec.europa.eu/commission/presscorner/detail/de/ip_20_589
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