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. UK MHRA Outlines New Medical Device Registration Process Starting January 1, 2021 September 11, 2020 Brexit was rife with drama, in no small part due to the complexities […]

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 to markets being served Infrastructure and logistics Geopolitical risk Economic stability Rule of law/low corruption Respect for intellectual property Free trade agreements Government support/economic incentives […]

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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 2017 release of the European Medical Device Regulation (MDR 2017/745). Late 2019 saw the release of the updated ISO 14971 risk management standard and three […]

Risk Management Review, Reporting and Postmarket Planning

As part of the risk review process, you’ll need to assess your risk management activities against the risk management plan on three levels: 1 – Has the plan been implemented appropriately? 2 – Is the overall residual risk acceptable? 3 – Are production and post-production information collection methods implemented? The summation of answers to these questions becomes your risk management report, which is part of your larger risk management file. The report documents the conduct and results of your risk […]

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All Topics, ISO 14971/Risk Management

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