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EU Commission promised 20 Designations 12 Notified Bodies Designated to MDR (9) & IVDR (3*) *All 3 IVDR Notified Bodies have MDR designation as well, so that can be counted as double counting. It depends on your perspective. 2 NB’s
Update of May 5 2017 Addition of the Published Documents “EU MDR & IVDR were Published in OJEU TODAY Friday May 5, 2017″ Stop the Presses and add these earth shattering Regulations to your reading list for the next week or
Since our original post (below) we have made 3 additional updates to provide you with a lot more info and resources. Check out our updates in this LinkedIn Article. Updates are all underlined: Mar 7, ’17 updates: * addition of the EU
Final texts of the EU MDR & IVDR (R = Regulation) have been released recently and start their transition periods sometime in the early to mid 2nd quarter of 2017. The MDD has a 3 year transition period and the IVDR
Blog focus BSI’s 7th in a series of White Papers for Medical Device, on Human Factors & Usability Engineering White Paper on The growing role of human factors and usability engineering for medical devices This white paper is on “The growing role