EU officials optimistic about proposed MDR/IVDR reforms

Top European officials said they are optimistic that amendments to the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) will be enacted quickly, but the amendments must also comply with legislative requirements, which will take several months.

European legislators, medical industry representatives, notified body representatives, and other stakeholders came together on 16 March for a high-level conference on medical devices hosted by the European Commission. The theme of the day was how the recent proposals to update the MDR/IVDR were progressing and when those amendments might take effect.

During a fireside chat, Neophytos Charalambides, the Cypriot presidency minister of health, said their objective is to create a simpler regulatory framework that addresses the significant hurdles that have been a concern for regulators, legislators, and the medical device industry.

"As you might be aware, it is our presidency's priority to work towards an autonomous European Union in all different aspects, and of course, health is one of the most important aspects,” said Charalambides. “Autonomy cannot come without having competitiveness. A clear, predictable framework will assist the EU towards this goal."

Charalambides said they need to address issues of device availability and EU's attractiveness for medical devices and IVDs. He emphasized that innovation is a priority and noted that the current certification process is very difficult for manufacturers. He also said they need to make the EU more predictable and efficient for companies that choose to come to the EU while maintaining high-level patient safety

"The proposed framework of revisions … aligns with the presidency's priorities, which is to enhance Europe's competitiveness, resilience and this would of course lead to stronger strategic autonomy for the European Union,” said Charalambides. “Clear and predictable regulatory framework is an enabler for Europe's competitiveness.

“It will assist businesses, particularly small businesses, on what really matters,” he added. “What really matters is innovation, global competition, and convincing them they should choose Europe for their investments."

Charalambides said the priority is to improve the lives of EU citizens and believes that the proposed MDR/IVDR amendments will improve access to medical products and create a more resilient European health system. While he noted that everyone has prioritized amending the regulations, that doesn't mean they all share the same position on how to move forward.

Charalambides said that after getting translations of the amendments, they will all go to a first reading and collect member state comments. Then they will pass those comments to the incoming Irish presidency, which is not the usual process but will ultimately speed things up by giving the new presidency a view of legislators from the beginning and allowing them to start work immediately as soon as they take over the presidency.

Tomislav Sokol, a member of the European Parliament and the European People’s Party (EPP), said his party has been vocal since 2024 about reforming MDR/IVDR and emphasized that it is prioritizing the reforms. He emphasized that for his party, it is a concrete promise rather than empty political promises.

Sokol echoed what others had said during the conference that the implementation of MDR showed there were a lot of problems, and while the initial idea behind it was good because it was intended to improve patient safety, unfortunately, a lot of things weren't thought through, and that led to significant regulatory hurdles.

"These problems of unnecessary bureaucracies and red tape, which have nothing to do with safety is what we consider to be the main issue,” said Sokol. “This is why we proposed concrete suggestions, concrete objectives, [about] what we want to achieve, and concrete measures."

Sokol said that while the European Parliament wants to ensure new changes are implemented to help the medical device and IVD sectors, they are also unable to rush the process because there are deadlines to be met under legislation. However, he said that of the 10 points in the plan, all have been either fully or partially fulfilled.

"This is not something that can just be done just because of the procedures in one or two months,” said Sokol. “We'll try to do it as fast as possible, there is a big convergence between what we think, at least at EPP ... there is a big convergence between us and the Commission proposal and because of that I think things should go smoothly but of course I cannot guarantee for the other political groups what kinds of ideas they might have."

Sokol opined that most parties will go in the same direction as the Commission, but it will take two to three months until the first draft report is published. Then he noted that there will be a deadline for other political group amendments, and then negotiations will start before the summer.

"I will not say we will do it in one month because that would not be serious, but we'll try to do it as fast as possible within the procedures we have in the European parliament," said Sokol.

Earlier in the day, Olivér Várhelyi, the European Commissioner for Health and Animal Welfare, characterized the MDR/IVDR amendments as a major overhaul of the European regulatory system that is necessary. He noted that medical devices matter to Europe’s economy and its citizens. With that in mind, he said they have heard and taken into consideration arguments from industry that the past MDR/IVDR deadline extensions weren't enough to prevent products from disappearing from the European market, and the regulations needed real reforms.

Among the reforms, Várhelyi noted that they have proposed fixed timeframes for conformity assessments carried out by notified bodies.

"This will make the certification process more uniform and predictable, and hopefully the fastest in the world," he said.

Besides the MDR/IVDR amendments, Várhelyi also noted that they have expanded the list of well-established devices that have been in use for decades and don't need additional data to remain on the market. But much of his emphasis to improve the European regulatory framework was to simplify the MDR/IVDR.

"We want to make it easier for medical device companies to bring their device to the market while maintaining the highest standards of patient safety in the world,” said Várhelyi. “Simplification means smarter regulation.

“It means focusing resources where the risks are the greatest,” he added. “It means getting rid of duplication and inefficiency and it means creating a system that is robust, predictable and sustainable."

Várhelyi said that everyone needs to play their part. He also noted that as part of the reforms breakthrough technologies will receive preferential treatment, sandboxes on the EU and national level will enable fit-for-purpose market entry procedures, artificial intelligence (AI) rules will be fully incorporated into the medical device legislation, companies will not be required to recertify their devices every five years, reporting will be more in line with the real patient safety needs, and devices that have been on the market for decades without any problem will not need clinical studies.

Rainer Becker, director for medical products and innovation at the European Commission’s DG for Health and Food Safety (SANTE), discussed the main elements of the proposed MDR/IVDR reform during the conference. He said the objective is to enhance the predictability and cost efficiency of certification. For example, he echoed Várhelyi and said they want to remove the maximum validity of certification for medical devices so that there is no need for automatic recertification after 5 years, whilst keeping periodic reviews. He also said they have proposed reducing the frequency of periodic safety update reports and make regulatory requirements more risk proportionate.

Becker also said the reforms are meant to support innovation and address special situations. For example, he said they want to adapt the conformity assessment pathways to the special characteristics and needs of high innovative devices and orphan devices.

"We propose a new dedicated pathway for breakthrough technologies, really those [devices] that have this incremental innovation that have a really that meet an unmet medical need that really bring us forward," said Becker.

Furthermore, he said they want to ensure there is regulatory coherence that aligns MDR/IVDR with other legislation. As an example, he said they want to align the clinical trials regulation (CTR) with IVDR for COMBINE studies. He also said the proposed changes would modernize the regulatory system by streamlining the regulatory framework, digitizing conformity assessments, and promoting international regulatory cooperation.

Conference-goers were also split into breakout sessions to discuss what other changes they could make to improve the European regulatory framework. Sabina Hoekstra-van den Bosch, regulatory strategy principal at TÜV SÜD, said that during the breakout session she led, attendees discussed short-term actions to improve medical device regulations.

Among the suggestions presented by attendees was to strengthen predictability by using available regulatory tools more effectively, such as the Common Specifications, expert panels, orphan pathways, conditional approval, hybrid audits, and the Annex VII implementation act. They also recommended improving the quality and efficiency of conformity assessments and fostering early, structured dialogues.

Hoekstra-van den Bosch also noted that attendees discussed long-term actions, including implementing a risk-based and lifecycle-oriented regulatory framework. Furthermore, she said they recommended improving legal clarity, consistency, harmonizing the framework, and creating mechanisms to resolve regulatory inconsistencies.

EC medical device conference

EU officials optimistic about proposed MDR/IVDR reforms

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