Latest EU MDR and IVDR Updates and Developments

The countdown continues toward the EU MDR (May 2021) and IVDR (May 2022) implementation deadlines. 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.   Which EU Notified Bodies Will Be Designated Under the MDR and IVDR? Most recent update: April 1, 2021 The EU MDR May 2021 transition deadline is just […]

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How Much PMS Data Should We Include in Our Clinical Evaluation Reports?

One of our customers recently asked this question, and it’s a good one. Much has been written about the need to maintain clinical evaluation reports (CER) throughout the entire life cycle of devices. There has been far more emphasis on postmarket surveillance (PMS) reporting in recent years, and the result is that clinical evaluation reports for established devices now often include a substantial amount of PMS data. Thus, when medical device regulatory professionals compile required postmarket reports, they rightfully wonder […]

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Virtual Medical Device Inspections and Audits: Here to Stay or a COVID-Era Blip?

Industry has a tendency to adapt quickly to changing market conditions, especially when money is involved. Government, not so much. When COVID hit the US in March 2020, in-person audits came to a screeching halt. Within months, when it became clear that the pandemic wasn’t disappearing anytime soon, medical device and IVD manufacturers pivoted and within a few months were conducting remote internal audits. Still, regulators weren’t convinced about the benefits of this newfangled video technology thing. That’s finally beginning […]

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