The New Date Is May 26, 2021
The European Medical Device Regulation (MDR) is finally set to take over, marking a significant shift from the Medical Device Directive (MDD). While medical device manufacturers and many entities involved in the supply chain received a bit of a reprieve when the date moved back from its initial scheduled launch in May of 2020, regulators have indicated that there will be no further delay despite challenges posed by the scope of the new directive and the COVID-19 pandemic.
Although the MDR was set to take full effect on May 26, 2020, many expected a delay was forthcoming as it became clear that the novel coronavirus was set to become a worldwide pandemic unlike any seen since the 1918 flu pandemic. It was only in April of 2020 that the European parliament decided to delay the switchover to the MDR to give relevant parties time to assess the impact of the pandemic and adjust accordingly. The news was welcome to manufacturers, although some question whether many of them would have been able to make the transition without a delay.
Nearly a year has passed since then, but there are still worrying signs that manufacturers still aren’t prepared for the switch despite added time to prepare. The pandemic has had a significant impact on nearly everyone, and even though medical device manufacturers aren’t always at the forefront of fighting the pandemic, they’ve nevertheless faced significant challenges; being a part of the greater medical field has only exacerbated these problems.
Acknowledging that COVID is not going away anytime soon, and with the EU MDR date of application coming on May 26, 2021, the European Commission issued a notice on January 1, 2021 stating that European Notified Bodies will now be temporarily allowed to remotely audit their medical device and IVD clients
Part of the difficulty facing manufacturers and others is the sheer scope of the MDR. The new directive places on emphasis on medical device safety, with clinical evaluations and hard data requirements making approval an onerous task even for the most experienced companies. Of note, the text of the MDR is about four times lengthier than that of the MDD, and the MDD had already been considered a strenuous directive that could be difficult to meet.
Although manufacturers received a reprieve, existing fears about their ability to meet the requirements of the new directive haven’t waned much; with so much time and effort being occupied by the pandemic, it’s still an open question whether companies have been able to use their time to prepare for compliance.
In fact, some may be less prepared now than they were a year ago. Needle manufacturers, for example, have been under significant pressure to ramp up production due to the heavy increase in hospitalizations due to the pandemic, and manufacturing for vaccines is still in the process of accelerating at an unprecedented rate. The European Parliament, when granting their initial delay, noted that they didn’t want to risk disruptions to the coronavirus response. It’s unclear if manufacturers are in a better position today than they were when the pandemic’s scope first became clear.
Downstream effects of the delay may prove to pose significant bureaucratic challenges in the coming years as well. MDD certificates are set become void on May 26, 2024, a date which has not been pushed back. Because compliance with the MDR requires audits and other in-person activities, travel restrictions, many of which are still ongoing, have led to challenges.
Additionally, the MDD allowed devices in distribution before 1993 to be grandfathered, meaning many well-tested and understood devices have been allowed to be sold for decades without having to meet the standards of the MDD. Under the MDR, all such devices lose their grandfathered status, leaving many manufacturers to deal with complex regulations, the likes of which they might be dealing with for the first time. While the MDR’s delay provided a bit of breathing room, the final clock is still ticking.
However, the EU has shown some flexibility in the past. Even though another full delay of the MDR seems unlikely before the May 26, 2021, deadline, certain types of devices have already received delays, and further targeted delays might still be on the table, particularly for essential medical devices with a long history of safe use. Regardless, manufacturers need to ensure they’re dedicating the resources needed for compliance.