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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IVDD vs. IVDR Gap Analysis and Checklist for 2017/746

If you market an IVD in Europe and are just starting to think about doing a thorough gap analysis for the In Vitro Diagnostic Regulation (IVDR), it’s definitely not too early to start. An IVDD vs. IVDR gap analysis helps determine where you are now and where you need to be. While the EU IVDR entered into force in May 2017, the final IVDR compliance deadlines will be here before you know it. This is a longer transition period than […]

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