Latest EU MDR and IVDR Updates and Developments

The countdown continues toward the EU Medical Device Regulation (EU MDR) May 2020 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. European Commission Issues… » Read more

COVID-19 Regulatory Resources for Medical Device and IVD Manufacturers

FDA and other global regulators have been rapidly publishing information intended to help medical device and IVD manufacturers respond to the COVID-19 crisis. On this page we have posted helpful links to various Regulatory Authority webpages and other information specifically related to medical devices. Note: The links below are intended for device manufacturers, not the… » Read more

All Topics, COVID-19

Get Your Medical Device or PPE on the EU Market to Help with COVID-19. Here’s How.

In the age of COVID-19, there may be confusion around how to get a medical device into the EU market to support European citizens grappling with this devastating pandemic. We are experiencing an exceptional event, and regulators know that they play a key role in getting life-saving medical devices and personal protective equipment (PPE) to… » Read more

All Topics, COVID-19, EU In Vitro Diagnostics Regulation (2017/746), EU Medical Device Regulation (MDR 2017/745)

Is Your Medical Device Company Ready for a Remote Audit?

If you’re among the millions suddenly working from home, you don’t have to despair about falling behind schedule with your audit plan. Technology can keep you on track. Working remotely is nothing new, and the pros and cons of doing so are well understood. Yet most audits are still conducted in person. Why? Well, some… » Read more

All Topics, Auditing

Understanding What Is Considered a “Significant” Change Under EU MDR Article 120(3) and MDCG 2020-3

Unless you were recently dropped off by an alien spaceship, you are well aware that the EU MDR imposes strict new requirements on medical device companies marketing their products in Europe. Many device companies have been scrambling to renew existing CE certificates granted under the Medical Devices Directive (MDD 93/42/EEC). Typically, manufacturers are choosing to… » Read more

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

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