The European Commission's Medical Device Coordination Group is pushing forward with detailed steps for industry on the assumption the EU Medical Device Regulation will go into effect May 26, even amid fears the coronavirus pandemic makes the already halting process more challenging.
The advisory group, made up of EU member government officials and some industry players, acknowledged in a document born from a meeting last week that the May implementation “has proven to be a very challenging task."
But the assessment of preparations lacks any references to COVID-19, potentially because it was prepared for endorsement at last week’s meeting and therefore drafted before Europe became the epicenter of the outbreak with Italy and Spain in virtual lockdown mode.
The potential for COVID-19 to disrupt implementation is front of mind for many. Late last week, German medtech trade group BVMed called for a postponement until the end of the coronavirus crisis, pointing to the effect of the outbreak on already stretched notified bodies to make its case. And one day earlier, EU notified body association Team NB warned the “outbreak is having an impact on the implementation of both [MDR and IVDR] due to travel restrictions.”
As for the MDCG, it abandoned plans last week to hold a physical meeting in Brussels amid the threat posed by the novel coronavirus but still discussed a slimmed-down agenda virtually. The meeting led to the publication of two texts, including a response to the European Council’s call for a check on how ready the EU and industry are for the new sweeping rules.
The response touches on potential upheaval in the medical device industry, including the “risk of shortages and disruption of supply of critical medical devices due to the lack of capacity for certification by notified bodies or the risk of reduced product portfolios.” The group found it difficult to quantify the extent of potential shortages and disruption.
Despite the uncertainty, the group contends the worst-case scenario has already been averted through the December 2019 change to permit Class I devices to benefit from a transition period that effectively extends the implementation of aspects of MDR out to as late May 2024. MDCG estimates the change “significantly alleviated pressure on notified bodies” and “ensured continued availability of certain essential devices.”
The MDCG accepts the change is far from a panacea, stating that “concerns remain, for the shorter term, about the capacity of the notified bodies.” Those concerns center on the potential for shortages to arise after MDR comes into force in May because it is impossible to immediately replace existing certificates as they expire.
Again, the group noted “the number of devices concerned is difficult to estimate.” Based on information from notified bodies, MDCG believes “a vast majority of devices are already engaged in the procedures of certification or have already been re-certified” but cannot be more precise at this time. The group expects the situation to normalize in the medium term.
The likelihood of a smooth transition could be affected by outstanding uncertainties, such as timing of the inclusion of MDR in a customs union agreement with Turkey, and the risk that devices certified by Swiss notified bodies will be ineligible for sale in the EU. Faced with the known and potential threats to product supply, MDCG is recommending manufacturers and notified bodies send regular reports and keep tabs on issues that could manifest in device shortages.
MDCG sought to reduce one source of uncertainty with a second document to emerge from last week’s meeting. The document is intended to clarify when changes to medical devices are viewed as “significant” under MDR. Under the terms of the transition period that runs to 2024, devices cannot undergo significant changes without being recertified, making it important that manufacturers and notified bodies understand how the term is defined.
In providing such a definition, MDCG has drawn on a joint industry position established last year by groups including MedTech Europe. Both feature flow charts designed to help determine if a change is significant.
Yet, the already tricky task of smoothly implementing the regulations looks set to be made harder by the coronavirus outbreak, which other parts of the EU machinery are working with the medtech industry to counter.
Over the weekend, Commission president Ursula von der Leyen outlined how the EU is working with the industry to ramp up production of masks and other protective equipment. The EU also adopted an export authorization scheme to keep protective equipment in the region. Separately, the Commission called for startups with COVID-19 technologies to apply for fast-track funding.