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

The EU MDR imposes strict requirements on medical device companies marketing their products in Europe. Many device companies scrambled to renew existing CE certificates granted under the old Medical Devices Directive, allowing them to sell that device in Europe until those certificates expire or May 2024, whichever comes first. Whatever the reason, companies need to be careful to make sure they do not make significant changes that would raise the ire of Notified Bodies and trigger a mandatory new 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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