Latest EU MDR and IVDR Updates and Developments

The countdown continues toward the EU Medical Device Regulation (EU MDR) May 2021 implementation deadline. Following are a series of articles covering key EU MDR and IVDR topics.  Check back often for up to date news on which Notified Bodies have been designated, UDI, the European Commission implementation plan, timelines, and more. EU MDR Gets… » Read more
All Topics, EU In Vitro Diagnostics Regulation (2017/746), EU Medical Device Regulation (MDR 2017/745)

Thinking About Moving Your Medical Device Manufacturing Facility Back to the US or Another Country?

There comes a time in the evolution of every medical device company when big changes need to be made with regard to manufacturing, most significantly where it’s done. There are many strategic factors to consider when moving medical device production to another country, including: Labor costs Access to highly skilled labor Local supplier network Proximity… » Read more
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What Notified Bodies Look for When Reviewing Your Medical Device Technical Documentation Under the EU MDR

If you’ve been involved in medical device regulatory affairs for 5+ years, you know all too well that the requirements around technical documentation associated with European CE Marking have tightened. The June 2016 release of guidance document MEDDEV 2.7-1 rev 4 on clinical evaluations gave many regulatory professionals heartburn and was followed by the May… » Read more
All Topics, EU Medical Device Regulation (MDR 2017/745)

Which EU Notified Bodies Have Been “Designated” Under the MDR 2017/745 and IVDR 2017/746?

EU MDR & IVDR Updates UPDATED MAY 29, 2020 With the MDR deadline quickly approaching, many medical device manufacturers still don't know for certain whether their Notified Body (NB) will be designated and when! Frustratingly, there is no published list of Notified Bodies seeking designation. However, the European Commission has stated that 44 MDR and 11 IVDR applications have been… » Read more
All Topics, EU In Vitro Diagnostics Regulation (2017/746), EU Medical Device Regulation (MDR 2017/745)
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