ARTICLE SUMMARY:
As large swaths of society transition into a literal standstill in response to COVID-19, big questions are circulating about the path forward for long-awaited device regulatory reforms in Europe. Some are calling for a moratorium, but the government appears to be speeding toward Medical Device Regulation implementation, in this week's Pathways Pick of the Week.
Things were anything but business as usual in Europe before the pandemic hit. The transition to the EU Medical Device Regulation (MDR) is slated for May 26, and many in industry have been questioning whether the system will be ready to make the jump.
With coronavirus halting travel and close contact, the ability of notified bodies to do their jobs in auditing device companies is severely restrained. Transitioning to the new, more stringent MDR was already a lot to handle, and industry has argued the lack of designated notified bodies and clear guidance was enough to support an MDR delay. The pandemic potentially sends into disarray whatever semblance of readiness was in place, some argue.
BVMed, the German medical device industry association, came out with a strong statement March 13 demanding a moratorium on the MDR until the coronavirus subsides.
"First Notified Bodies close or are limited in their work. Experts and auditors are no longer allowed to travel. Authorities are affected. Production facilities are affected. Suppliers are breaking away. And in addition to the known problems: too few Notified Bodies, too few experts, missing Legal acts and guidelines. The double-hit medtech industry now needs an MDR moratorium,” BVMed CEO Dr. Marc-Pierre Möll stated.
On top of such demands and in parallel with emergency efforts to conserve supplies of personal protective equipment, the EU government seems to be going the other direction on MDR. The MDR policy-making body, the Medical Device Coordination Group (MDCG), met (virtually) March 11-12 and followed that up with the rapid rollout of important documents necessary for the implementation of MDR.
Notably, as the meeting was going on, MDCG issued a “Joint implementation/Preparedness Plan” that made no mention of COVID-19. It addressed the pre-pandemic urgent needs for more notified bodies, document, and the like. Then, this week, the EU group has so far rolled out five highly awaited guidance documents addressing:
- How to define “significant change” when a company is determining whether a device can continue to enjoy the MDR grace period (See “Modifications in the MDR Era: The Ambiguities of ‘Significant Change,” Market Pathways, October 7, 2019);
- Clinical/performance evaluation of software;
- Transitional provisions for Class I devices;
- Newly mandated “implant cards” that must be provided to patients; and
- Unique Device Identification, including the “Basic UDI-DI” for identifying device groups and making changes to individual UDI-DIs.
Meanwhile, notified bodies confirmed challenges it is facing both in carrying out responsibilities under the current Medical Device Directives, and transitioning to the new regulations.
“Notified Bodies are in communication with their designating authorities to share contingency plans to deal with this extraordinary circumstance especially in areas affected by COVID-19,” TEAM-NB, the EU notified body industry association, said March 12.
EU policymakers may be noting the fact that they face challenges and are going to have to grant leeway to ensure medical device access whether the directives remain in effect or MDR begins to apply, so they might as well move forward with MDR.
The one challenge to that approach is that a joint on-site audit is required of all notified bodies seeking designation to operate under the new regulation, which is not possible under travel restrictions. However, according to a January 21 notified body “State of Play” document from the EU government, 38 of the 44 bodies that have applied for MDR designation have already undergone on-site audits, meaning it may be possible for more bodies to be designated during the current emergency.
But facts on the ground are changing daily, and it remains unknown what additional oversight functions may need to be sidelined as the outbreak grows in each country.
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