In order to prevent supply bottlenecks or delays in the market launch of medical devices during the Covid-19 crisis, application of the Medical Devices Regulation (EU) 2017/745, which was originally scheduled for 26 May 2020, has been postponed by one year.
The European Parliament approved a Commission proposal to this effect in mid-April.
Among other things, the regulation lays down uniform, more stringent criteria for notified bodies for the certification of medical devices, and governs the procedure for approving clinical trials of them.
www.europarl.europa.eu/news/en/press-room/20200415IPR77113/parliament-decides-to-postpone-new-requirements-for-medical-devices
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