Which EU Notified Bodies Have Been “Designated” Under the MDR 2017/745 and IVDR 2017/746?

EU MDR & IVDR Updates

UPDATED October 23, 2020 With the MDR deadline approaching, many medical device manufacturers do not know for certain whether their Notified Body (NB) will be designated and when! There is no current list of Notified Bodies seeking designation. However, the European Commission has stated that 44 MDR and 11 IVDR applications have been received. That represents a surprising 86% of current MDD NBs and 50% of IVDD NBs. The organizations on the list below account for more than 80% of […]

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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 […]

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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 market as quickly as possible. Manufacturers that have the desire and ability to ramp up their manufacturing capacity to fulfill unmet needs in the EU […]

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What Does “State of the Art” Actually Mean in the EU MDR and IVDR?

Originally published in May 2018, this article was updated on March 3, 2020. Confused? It’s understandable. Most of us think of “state of the art” as describing the latest and most advanced stage of a technology. For example, most people would consider a solar-powered pacemaker to be state of the art. (Don’t hold your breath for this one to come to market.) Yet, this notion of state of the art isn’t what is meant in the context of the EU […]

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