Commission's Latest Stats Show How 10 MDR/IVDR Notified Bodies By Q3 2019 Is Now Possible
The European Commission’s latest figures indicate that at least 20 notified bodies will be designated by 26 May 2020 - the date by which the new medical device regulation will become fully applicable. But is there still enough time?
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The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.
With just a few months remaining until the full application of the EU Medical Device Regulation, notified body designations are still only trickling through. Ireland is the latest EU member state to have a resident MDR notified body.
In this second article of a two-part series, Eithne Lee of ISO Life Sciences global consultancy identifies some of the problems that medtech premarket innovators and SMEs are facing, with the EU MDR application date now less than four months away.