EU Parliament Approves Extension of Date of Application of EU MDR 2017/745 by 1 Year to May 2021

The EU Parliament has formally approved the extension of the date of application of the Medical Device Regulation 2017/745 until May 2021, adding an additional year for manufacturers to transition to EU MDR for their Technical Documentation and their Quality Management Systems. This will allow some manufacturers additional time to transition. While notified bodies will likely still continue to take applications for EU MDR certification before then as many of them currently are. The extension may also allow some manufacturers, if permitted by their notified bodies, to file for first time CE Mark under the Medical Device Directive 93/42/EEC for a limited time.

See formal announcement here: https://www.europarl.europa.eu/news/en/press-room/20200415IPR77113/parliament-decides-to-postpone-new-requirements-for-medical-devices