Medical Device Registration under UK MHRA: UKCA Marking Requirements, UK Responsible Person, and More

If you have worked in European regulatory affairs for some time, it’s hard to wrap your brain around the fact that the United Kingdom is no longer part of the European Union. The UK will once again forge its own path, interacting with its continental neighbors in a manner similar to Norway. Yet the key difference is that Norway has chosen to emulate the EU Medical Device Regulation (2017/745) as national law and require CE Marking. In late 2020 the […]

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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?

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 MDR, IVDR, and risk management. As such, manufacturers often face challenges in assessing state […]

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EU MDR Vigilance Reporting Requirements and MEDDEV 2.12-1 Rev 8: What Has Changed?

Important: Since the new EU MDR will become mandatory for all postmarket activities beginning May 26, 2021, medical device manufacturers need to ensure that their procedures are updated and employees responsible for vigilance reporting are trained on the change in reporting timeline. What About MEDDEV 2.12-1 Rev 8? MEDDEV 2.12-1 Rev 8 was published in January 2013 and provides guidance to medical device manufacturers on market surveillance. It continues to be the primary guidance document for vigilance reporting, even with […]

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