Surprise! Class 1 Manufacturers Must Meet These Specific EU MDR Requirements by May 2021

Oriel STAT A MATRIX explains how the European Medical Device Regulation imposes new requirements on Class I device manufacturers

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 […]

Your Notified Body may ask to see your strategy for regulatory compliance during your next audit. Do you have one?

As European regulatory compliance becomes more complicated many medical device and IVD manufacturers have had their Notified Bodies ask them for a written “strategy for regulatory compliance” document. Given a choice, most regulatory professionals would prefer to not experience the same “deer in the headlights” moment these manufacturers must have had when asked for this by their auditor. The need for a regulatory strategy stems from Article 10(9a) of the EU Medical Device Regulation (MDR) or Article 10(8a) of the […]

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. European Commission Opens Door to Remote Notified Body Audits…For Now January 13, 2021 Finally acknowledging that COVID is not going away anytime soon, and the EU MDR […]

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