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

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)

The EU MDR Has Been Pushed Out to 2021. That’s a Golden Opportunity…

Some will yawn, some will sigh in relief, and some will express frustration that their mad dash to become compliant with the EU Medical Device Regulation (2017/745) deadline was for naught. But few can deny that in light of COVID-19, delaying the start date of the EU MDR from May 2020 until May 2021 was… » Read more

All Topics, EU Medical Device Regulation (MDR 2017/745)

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