Euro Convergence: Experts support MDR, IVDR tweaks to ensure competitiveness

BRUSSELS – Experts discussed the challenges that medtech companies have faced in complying with the Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), with some voicing support for legislative fixes that would centralize aspects of the current regulatory framework to promote competitiveness and innovation.

Koen Cobbaert, senior manager for regulatory science and policy at Philips, moderated a panel discussion during the opening plenary at RAPS Euro Convergence 2025. The panel discussed regulatory challenges that medical device and diagnostics manufacturers face in Europe as they work to meet requirements set in the MDR, IVDR, and other critical legislation. He said that small- and medium-sized enterprises (SME), which comprise about 90% of the 37,000 medtech companies in Europe, have been hit especially hard by the new regulations.

Peter Bischoff-Everding, a senior expert at the European Commission, said that the medtech sector in Europe is thriving and offered insight into what the Commission is doing to ensure it continues to do so.

"That means we need to have the right rules in place to support the competitiveness and innovation capacity of the industry, of the EU manufacturers, especially the many small- and medium-sized companies in this sector," he said.

Bischoff-Everding said that while the Commission prioritizes patient safety, it wants to avoid any unintended consequences of MDR and IVDR and prevent stifling competitiveness, innovation, and the availability of medical products. He noted that the Commission is conducting a targeted evaluation of MDR and IVDR with national authorities, notified bodies, manufacturers, and other stakeholders. So far, he said it has received 544 responses to the call for action and 332 responses to the public consultation, and they plan to conclude their review of the responses by the end of the year.

Bischoff-Everding said the Commission will analyze the responses to find ways to simplify the MDR and IVDR to reduce regulatory burdens with a particular focus on SMEs. While the consultation is ongoing, he said the Commission is also looking to use flexibilities in the current framework to improve the situation, including implementing a regulation for electronic instructions for use (e-IFU) and establishing an expert panel on orphan and pediatric devices by the second quarter of 2025. He also said they plan on expanding the list of well-established technologies (WET), down-classifying certain WET products, implementing new rules for notified body requirements, and a guidance on breakthrough technologies (BtX) by the end of the year.

“The medtech sector is a very agile sector and it needs an agile regulatory framework, one that allows industry to bring innovative medical technologies to the market in a timely manner for the patients,” he said.

Bischoff-Everding also noted that notified bodies have said that some manufacturers are still holding back from filing their applications to conform their products to the new regulations. He warned that he does not expect the implementation deadlines to be extended again.

Jana Russo, medical devices manager at MedTech Europe, said legislative reforms are needed to address the structural problems in the current regulatory system. She said there are many actors regulating medical technologies, but no one "captain of the ship" who can take responsibility for ensuring the safety and effectiveness of medical devices allowed on the market and ensuring innovation stays in Europe. She further highlighted the need for a centralized structure to ensure one entity takes the helm of the medtech regulatory framework.

"What we want to see is a governance structure that is central, unified, single, but above all, it's patient-centric, and this is its main mission," said Russo. "We really want to see a mandate that allows this mission to be carried out. We want to see empowerment, so that this structure can take system-level decisions."

"There is a number of roles and responsibilities that we would foresee for the structure to have,” she added. “From our point of view, it's more important that these are very well defined, that the structure is medtech specific, has medtech specific expertise and resources."

Erik Vollebregt, a partner at Axon Lawyers, said he is a fan of the centralization idea but pointed out that this was the expectation when MDR was first proposed. Over the years, he has become more disappointed as a centralized framework has not materialized. To achieve centralization, he said stakeholders should take inspiration from the recently passed AI Act, which he described as modern CE-marking for complex products.

"Of course, there are different opinions on what would be good centralization, but I think this would be the template that solves everything in the best possible way and does justice to the CE marking system," said Vollebregt.

While stakeholders consider long-term reforms to the regulatory framework, Russo said specific steps can now be taken to improve the system, including simplifying the regulatory and conformity processes. For example, she said that the binding timelines for decisions could also include maximum decision timelines and more cost transparency. She also said regulations could be changed to extend the validity of products from five years to ten years, and called for structured dialogues.

"That would certainly send a strong message to industry that wants to innovate in Europe because what we often hear from members is that the great thing about [the US Food and Drug Administration] FDA is that you can talk to them,” said Russo. “It would be great if in Europe we could also talk to each other.”

Euro Convergence: Experts support MDR, IVDR tweaks to ensure competitiveness

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