Euro Convergence: Experts weigh in on proposed MDR reforms

LISBON – A panel of experts representing regulators, industry, and notified bodies gave their opinions on the proposed revision of the EU Medical Device Regulation (MDR) at the RAPS Euro Convergence 2026 conference on Wednesday.

While their sentiments were largely supportive, a notified body representative urged the European Commission to maintain proactive surveillance of devices to protect patients.

Commission’s view

Last year, the Commission proposed targeted revisions to MDR to help ease regulatory burdens and improve the availability of devices on the EU market.

Flora Giorgio, head of the medical devices unit within the Commission’s DG SANTE, encouraged attendees to read the proposed revisions themselves, rather than rely on what others have said about them. The objective of the revisions, she said, is to address the challenges facing a range of stakeholders without being overly detailed or descriptive, as this could ultimately hinder medical device development.

After amending MDR three times, Giorgio sad the Commission decided to propose a more comprehensive update to address structural deficiencies, reduce costs, and prevent devices from exiting the EU market. The goal, she said, is to make the framework more predictable, while adapting to the changing realities of the medtech industry, and to simplify regulations while reducing administrative burdens.

"We are in this acceleration phase now of new challenges, new technologies, that bring unheard challenges that 10 years ago were not on the table," Giorgio said. She added that the Commission wanted to ensure all stakeholders were considered when proposing the updates.

Giorgio emphasized that the reforms are intended to simplify rather than cut regulations. By adapting the framework to allow for more risk-based oversight, regulatory professionals will have more discretion when certain things are needed, she said.

"We need to give the common rules for everybody, because not everybody can do what they want," said Giorgio. "With a different governance structure, with the possibility for the Commission as well to use more empowerment and make rules more clear.

"Less is more sometimes," she added. "So, less guidance, maybe, but more empowerment to really set the frame for everybody, and then everybody should act and exercise their professionalism and their expertise to decide."

A one-size-fits-all approach to regularly recertify products, regardless of their risk profile and compliance history, was not proportionate and created unnecessary duplication with the continuous and postmarket surveillance activities, Giorgio said. As a result, the Commission has proposed changing the certification process.

Giorgio said that the MDR reforms aren't removing recertifications but rather removing the certificate's validity date and replacing it with periodic review. She said the Commission realized there were significant administrative burdens in validating the certificates.

"We want to make sure that the certificate is there and reassure the competent authorities that things were looked at," said Giorgio. "We believe that the periodic review is a much more flexible mechanism to do that and not create these five years, one size fits all [approach]."

Judite Neves, health products director at Portugal's National Authority of Medicines and Health Products (INFARMED), said her organization concluded that MDR had room for improvement. She noted that certain topics needed clarification, simplification, and updating, which led INFARMED to work with the Commission and other stakeholders on the proposal.

"All these aspects are very critical and very relevant for competent authorities," said Neves. "In addition to safety and innovation, this proposal includes a new focus on European market competitiveness; responding to the needs of the sector, and to political and strategic guidance.”

Challenges and opportunities

Neves acknowledged that there will be challenges ahead, but with stakeholder cooperation, she said they will achieve a regulatory system that better responds to the needs of the healthcare system as a whole.

Panel moderator Gert Bos, chief scientific officer at QServe Group, agreed with the sentiment that there are significant challenges ahead for stakeholders, but reminded the audience that the aim of the regulation is to improve patients' lives.

"We do this to improve the system, and we do this for patient safety," he said.

Royth von Hahn, senior vice president of medical health services at TÜV SÜD, said the stakeholders represented by the panel share the same objectives and agreed that reform of MDR is needed. However, he said that notified bodies face a very specific reality.

"We see a lot of very good manufacturers, very diligent in their regulatory work, and we totally understand that more scrutiny will not help them or us," said von Hahn. He noted that reputable manufacturers of high-risk products are audited every other week by regulators worldwide, and adding another audit requirement wouldn't provide significant added benefit. However, he also warned that the regulatory system needs to ensure it is preventive rather than reactive.

Von Hahn said that since MDR went into effect in 2017, TÜV SÜD has assessed more than 7,300 products and identified more than 62,000 deficiencies. He noted that two-thirds of the deficiencies were technical, which doesn't mean the products were unsafe, but rather that the evidence of compliance for the products was incomplete. He also noted that a third of the products had administrative deficiencies.

"We need to make sure that we identify the really critical ones, and we can act before something happens," said von Hahn. "The reality the notified bodies live in is we find all these things, and in every authority audit or joint audit, we get [told] you are not doing enough."

Von Hahn said that when such deficiencies are detected, notified bodies will be blamed for not digging deeper or doing enough to ensure manufacturers are in compliance. He said they want to find the right balance between identifying the manufacturers that need auditing and applying a level of scrutiny that can help identify problems.

The solution, von Hahn said, should be a risk-based approach that builds trust and confidence in manufacturers over time. It should require broad scrutiny of manufacturers at the beginning, but as manufacturers demonstrate they are trustworthy in complying with regulatory requirements and that their products are not subject to critical failures, they should be subject to lighter oversight.

"We need to define the criteria to then reduce scrutiny here that will benefit the good manufacturers," said von Hahn. "It will give all these benefits we want to achieve to those who really deserve it, and it remains a high-level of scrutiny and in line with the risk-based approach to those where we need to take care that products don't fail on the market.

"We know what happens if only one high-risk product fails on the market," he added. "We need to make sure that we are able to prevent that from happening."

Von Hahn said such a system would also benefit manufacturers who adopted MDR early because they already have a track record of compliance. These early adopters who took on the burden of MDR would benefit from their hard work.

Von Hahn noted clear definitions and criteria are critical.

"Then, make sure that that is consistently implemented. We know what happens if there is too much room for interpretation," he said. "We've seen that in the first couple of years of MDR where we had more than 100 MDCG guidance documents to explain what was meant and how to interpret things.

"We should make sure that we don't run into that same issue again," he added.

Industry perspective

Elizabeth Gfoeller, corporate director of regulatory affairs at MED-EL, thanked the Commission and other stakeholders for their work to reform MDR. She said the proposal was very comprehensive and tackled everything the industry had proposed.

Gfoeller said that removing the five-year certificate expiration is a major improvement, as that requirement caused significant problems for manufacturers worldwide. She praised other aspects of the proposed reforms, including greater alignment with other EU laws, less administrative work from notified bodies, clearer language for classification rules, orphan and innovative device pathways, and proportionate and targeted sampling. She also touted the proposal to create clearer, formalized change reporting for notified bodies, including support for predetermined change control plans (PCCP).

"There are a great number of steps to get us towards an EU-wide and notified body governance, but we're not fully there," said Gfoeller. "In my view, we could do more to make it more structural, and maybe we will eventually get there. There is a lot of cost and default postmarket obligation still."

Gfoeller noted that pricing controls were not mandated and that manufacturers' costs are still very high. She was also concerned about defined and binding timelines for conformity assessments, undefined deadlines for full EUDAMED functionality, additional clinical evaluation consultation procedure (CECP) review, and the lack of recognition of well-established technologies in higher risk devices.

Gfoeller suggested several additions to the proposed reforms that she said could further improve MDR, including creating a pre-submission, single opinion for industry on clinical regulatory strategies for the European market.

"That single opinion would be recognized by all, and that would be able to be done altogether," said Gfoeller. "Whoever needs to be in the room to let that happen, that's what should happen, as opposed to having multiple points to decide strategy."

Kelly van der Geest-Aspers, strategic advisor for medical technology and innovation at Erasmus, said that that there was a significant drop in available medical devices in the EU after MDR went into effect, and that hospitals are currently feeling the effects of expiring transition timelines and delegation periods. She said there is also a lack of transparency, which makes it hard for healthcare providers to predict when they may lose access to medical devices.

"I know that a lot of people in industry now think that we as hospitals picked up a new hobby to develop medical devices and to be competitors of the industry... That's not what we want," said van der Geest-Aspers "We just need devices to help our patients, and that's why we sometimes need to develop and modify our own devices, but we don't want to take the responsibility of being a medical device manufacturer."

Ultimately, Giorgio urged all stakeholders to be brave and embrace a new mindset. She said everyone should be more pragmatic, take more responsibility and accountability, and accept that there will be risks. She also said that the Commission has had challenging discussions with the concerns raised by the notified bodies and is understanding of their perspective but ultimately said they need to empower all stakeholders and trust each other.