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The EU Medical Device Regulation

Note from the editor

In the absence of the COVID-19 pandemic, the medtech industry would now be months into new oversight under the years-in-the-making EU Medical Device Regulation. 

Many fears and predictions regarding that massive change in quality and safety rules would likely be the same. Among them: insufficient notified body capacity, lack of complete guidance on how to comply with upcoming requirements like the Eudamed database, and company-by-company restrategizing on whether or not the regulatory burden warrants introducing or maintaining certain products in the EU market.

The coronavirus, of course, added new challenges to implementation, even as the EU finally acquiesced to a delay to the date of application for MDR by one year.

In the time leading up to May 2021, companies that weren’t prepared for the original start date have extra months to catch up. At the same time, those that had been on track are attempting to progress with product certifications and refine their systems, but face hold-ups to steps like in-person audits and certain clinical testing given distancing measures outside of their control.

Even with the extra breathing room, the industry is pushing for other pandemic-spurred changes, such as the ability for notified bodies to conduct virtual audits and a delay to MDR’s companion, the In Vitro Diagnostic Regulation. So far, the bloc has resisted a bid to push out IVDR's 2022 go-live date, but given the fast action on the MDR and evolving impacts of COVID-19, that date may be far from certain.

Either way, the changes mark a major shift in the regulatory landscape for the industry that companies will be grappling with for years to come.

Maria Rachal Editor

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