MedTech Europe Warns Over ‘Untenable’ Transition to EU MDR/IVDR

Regulatory NewsRegulatory News | 17 April 2019 |  By 

MedTech Europe sent an open letter to the European Commission (EC) on Monday to urge immediate action on implementing the new medical device and IVD regulations as the transition is becoming “clearly untenable.”

The letter from the trade association’s CEO Serge Bernasconi underscores the growing urgency and need for the EC and member states to finish what they started in 2017 with the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR). The letter highlights the current lack of progress to implement both regulations, while warning of potential access issues to medical technologies in the EU.

As examples of limitations in the road to the new regulatory landscape, Bernasconi cited the fact that just one notified body (NB) has been designated against MDR—UK-based BSI, the growth in product categories in the EU market post-transition that will add tens of thousands of devices under NBs’ supervision and all the new medical devices requiring certification for market entry.

NBs “will typically take 3-9 months to complete a product re-certification, and it is expected that it will take them even more time for new MDR certification,” Bernasconi said, pointing to a prediction that up to just 12 NBs will be designated by year’s end. “This is way too late, insufficient and gives no guarantee that NBs would have enough capacity to ensure continued regulatory approval of devices by May 2020.”

The issues regarding NBs have been voiced by many in the past few years, especially with the threat of a no-deal Brexit. COCIR and MedTech Europe are some of those that raised awareness on these issues.

“This situation is clearly untenable, and time has run out to build a functioning regulatory system,” Bernasconi added. “This set of circumstances will profoundly disrupt the medical technology internal market and create yet another significant ‘Cliff Edge’ putting patient safety, health care services and EU health care environment in a major disarray.” He further argued that industry is now ready to submit product files to comply with MDR but “cannot do so” because the new system “is not ready to function.”

The deadline for MDR’s system to be fully operational is now, not 13 months away, Bernasconi said.

Yet another challenge creating more uncertainty for industry relates to the ongoing lack of regulatory guidance. The European Medicines Agency released the first in a series of MDR guidances in February on implementing Article 117. Documents endorsed by the member states group the regulations established began trickling out last February, with the last one offering some additional guidance on MDR’s version of Eudamed. The EC, however, has endorsed few of Medical Device Coordination Group’s (MDCG) documents. Topics with the recognition so far include unique device identification and nomenclature.

A set of two MDR/IVDR corrigenda was released last month, marking the first move for fixes. MDCG, meanwhile, called for urgent clarifications around Article 54(2)’s exemption criteria last month too.

The last time the EC updated its rolling plan on MDR/IVDR essential implementing acts and actions was in February. The update, however, was a letdown for industry as the race to compliance relies on several acts and actions that have yet to be completed. MedTech Europe reported on these MDR “burning points” and others, including NBs’ timely availability and readiness for greater workloads, this month.

Bernasconi also took issue with the transitional periods as “attempts to provide some relief to the system through a ‘grace period’ and a ‘warehousing’ clause.” But he said these “mechanisms only work for a portion of medical devices currently available,” so “they just partially achieve their initial objective.”

MedTech Europe included an annex with additional details on the need for contingencies due to the two mechanisms in MDR—the grace period and the “warehousing provision”—to provide the needed relief.



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