Convergence: MDR timeline extension is smoothing transition, but concerns persist

MONTREAL – The European Union’s Medical Device Regulation (MDR) timeline extension has addressed some of the issues manufacturers raised with the transition period but the process of recertifying products is still time and resource intensive and may cause some companies to pause before entering the European market, according to a panel of experts who spoke at RAPS Convergence 2023.

Every manufacturer will have a different experience with MDR transition depending on their size and available resources, said Gert Bos, executive director at Qserve Group in the Netherlands. “I would say, in general, we see a lot of wait and see with smaller manufacturers – small and medium sized,” he said.

Some manufacturers have expressed confusion about the guidance and other documents being released, Bos said. “[A] manufacturer keeping up to date with all of these changes, all of these guidances, is going to be very, very difficult,” he said. “It's never complete and it's not about the topics that they need the guidance to.”

Other companies are worried when they learn of the recertifying requirements. As a result, manufacturers are largely in two camps: either on track with MDR or waiting to bring their products to market in Europe until they gather real-world evidence, Bos said.

Learning from the past

Under the MDR transition timeline extension, the derogation period for Class III custom-made devices ends in May 2026 and the sell-off provisions for the MDR and the In Vitro Diagnostic Medical Devices Regulation (IVDR) have been abolished. Additionally, the transition deadline for Class III and IIB implantable devices has been extended to December 2027, while the transition for Class IIB non-implantable devices, Class IIA, and Class I devices has been extended to December 2028 (RELATED: Council votes unanimously to extend MDR deadlines, Regulatory Focus 7 March 2023).

“We worked very closely with the Commission in the drafting to try and ensure that it was as smooth a transition as possible,” said Suzanne Halliday, head of the BSI medical devices notified body based in the United Kingdom.

Sabina Hoekstra-van den Bosch, global director of regulatory strategy of NBCG-Med/TÜV SÜD, told attendees that the MDR/IVDR “state of play” evaluation report is forthcoming and will be published on time, unlike the delay seen with the Medical Devices Directive in the 1990s. “Last time it was delayed. This time, the discussion is very, very early,” she said.

Stakeholders had previously expressed concern not only about the impending deadline, but also the lack of notified bodies available to review products transitioning to MDR (RELATED: Experts: MDR transition delay needs clarification, industry engagement to succeed, Regulatory Focus 10 January 2023).

“It’s probably not a secret to anyone the transition from the previous regulatory framework -- from the directives, to the medical device regulation that was adopted in 2017 but then became applicable in ’21 -- has been very challenging for everybody: for the manufacturers, for the notified bodies, for the competent authorities,” said Peter Bischoff-Everding, legal officer in the European Commission’s directorate-general for health and food safety.

However, Bischoff-Everding noted the situation has “significantly improved,” and there are now 39 designated notified bodies dedicated to MDR. He emphasized, though, that the extension of the MDR transitional period is not a postponement of the MDR application and applies to certain legacy devices that are already on the market.

CE mark challenges

Bassil Akra, chief executive officer of Akra Team GmbH, said he sees the MDR changes as positive but when the implementation and the amendment to the implementation timeline came out, “it felt like a punishment to some of these manufacturers who were actually committed from the beginning.”

There is also lot of additional work being performed by large manufacturers in order to receive a product’s CE marking due to the need to register in various European countries, Akra added.

The CE marking “is important for industry,” he said, “but it is costing a lot of efforts and a lot of work, and a lot of surprises are coming out because you believe you have a system which is up and running in the right way, but it's still actually leading to challenges.”

Is innovation leaving Europe?

During a Q&A session, Richard Holborow, BSI's Global Head Clinical Compliance, questioned the narrative that innovation is leaving Europe as a result of the MDR changes, saying that a lot of the claims are “hearsay and not actual evidence.”

Bos agreed that innovation in Europe is not coming to a complete halt. Rather, “micro innovation is hindered because of the change control, and so on,” he said.

“There will still be some big step innovations if the product is good enough, and if you can really reach a high market share with the product, and if the margins are good enough,” Bos said. “There's still some of that going on. But you're asking the impossible. You're asking for joint industry to come up with the evidence on why they're quitting Europe or why they're discontinuing certain types of products.”

Akra said that having notified bodies involved early on is critical to support innovation and small manufacturers. “[N]o one wants to invest in a study design and then they will get back and to the European notified body and they will tell them, sorry, it was wrong,” he said.

However, Halliday said it is “a little early to be judging the failure of the system and the lack of things getting to market.”

“The notified bodies started to work on initial MDR work as of the date of application of the MDR, because until that point, we were doing a lot of directive work. So, it's really only two years of experience that you are seeing right now,” she explained. “And the notified bodies have more capacity, there are more notified bodies, and they are getting smoother and faster, and there is more harmonization and consensus.”

Gert Bos is the chair of RAPS and Sabina Hoekstra-van den Bosch is a director of RAPS, a nonpartisan, nonprofit professional society. Their comments represent their views only.

Convergence: MDR timeline extension is smoothing transition, but concerns persist

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