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

With a one-year reprieve to EU's MDR, some procrastinate, others speed ahead

COVID-19's impact on notified body capacity, pace of information from lawmakers and company resources are among the confounding variables.

• Published Aug. 26, 2020

EU MDR costing smaller medtechs 5% of their annual sales: survey

• Published Aug. 31, 2020

MedTech Europe beats drum for virtual audits, IVDR delay

The one-year delay to EU MDR has been crucial, but there's been "radio silence" from lawmakers on calls for a similar delay to the In Vitro Diagnostic Regulation, said regulatory lead Oliver Bisazza.

• Published Aug. 24, 2020

Eudamed's first section to go live before year's end

• Published Aug. 19, 2020

Notified bodies list for incoming EU regs hits 20 with designation of DQS for MDR

• Published Aug. 10, 2020

European Commission lays out timeline for next steps toward MDR, IVDR

• Published June 4, 2020

Are CFOs ready to go with the EU Medical Device Regulation?

Requiring fewer applications to submit for approval, the new process could ultimately cost companies less.

• Published May 12, 2020

It's official: EU finalizes 1-year MDR delay

• Published April 24, 2020 • Updated April 27, 2020