Medtech 2025: EU Regulatory Outlook Brings Challenges

We have allowed our policy discussions to be consumed by framing innovation versus regulation. To do this is to miss the point. New technologies can hold great promise, but only rigorous evaluation can objectively demonstrate that the technology is safe and beneficial for patients. We need clear regulatory requirements to promote safe innovation.

Our key challenge is that clinical evidence requirements are procedurally framed, resulting in multiple possible pathways, but little predictability that an applied strategy may meet the requirements of the multiple regulatory bodies that are encountered as part of the translational development.

We need to develop a strategy for clinical evidence that can accommodate permanent implants with critical function but also low-risk medical equipment where clinical evidence requirements can be streamlined. We need cohesive advice for and evidence specifications on an EU basis.

The ‘target evaluation’ of the European Commission offers the first opportunity for policymakers to understand the practical challenges faced in the system. This could allow us to develop, for the first time in Europe, strategic priorities that can address these challenges. That would be a major ‘win’ for our system, and it holds the promise of a more functional system in future.

Going into 2025, the IVD and MD Regulations remain slow, costly, unpredictable and complex. This is impacting both availability of devices for patients and SME competitiveness.

We trust that the European Commission’s targeted evaluation will lead to meaningful reform packages for both the IVDR and MDR.

Beyond a comprehensive reform, the sector already needs certain shorter term regulatory changes in 2025 to bridge the time between now and when reform packages would be published. We need implementing acts to make assessment timelines and change control mechanisms more efficient and predictable. Pathways are needed for breakthrough innovations as well as orphans and pediatric devices. We also need to address the burden of recertification by adapting certificate validity to the lifetime of the device, or at minimum in the short term by extending certificate validity to 10 years.

There are several areas where the European Commission, with the support of all impacted stakeholders, can improve the system in the short term and so avoid further impact on patients and health systems in view of the availability of (future) lifesaving and life-sustaining medical technologies. These should include the above-mentioned areas needed for short-term action.

The EU member states have never given the European Commission sufficient human resources for it to implement the Medical Device Regulations fully. There are more medical device regulators per capita in the EU than in the USA but they are “hidden” within the notified bodies, so there is a vacuum at the heart of the system that makes it impossible for the small Medical Devices Unit in DG SANTE, for example, to develop common specifications with transparent evidence requirements.

The risk that devices will disappear from the European market may at last ensure that sufficient manpower is provided for effective central coordination of the EU regulatory system.

Between 2021 and 2024 the EU funded a unique collaboration between medical associations, academic institutions, national regulatory authorities, notified bodies, health technology assessment agencies, and patients’ associations, with an advisory board that included members from manufacturers’ trade associations for the Coordination of Research and Evidence on high-risk Medical Devices (CORE-MD;). The project has published more than 30 scientific papers including detailed recommendations for regulators. All the deliverables are now being reviewed by a task force of national regulators and officers from the European Commission.

Hopefully, the CORE-MD outputs will be used to translate scientific evidence into EU regulatory guidance.

The atrophy in the system continues to be a source of amazement for me. So many aspects are not functioning and there seems to be no sense of urgency at all to make changes.

The Commission should be properly resourced to fulfil its role under the MDR and IVDR which have been encroached upon by the Medical Device Coordination Group. Member states should both instruct and allow notified bodies to be part of the solution by providing clear and uniform instructions for what a structured dialogue and a compliant procedure look like, and the subjects that can be addressed in structured dialogue. These should include clinical strategy and clinical data required to support the strategy.

Either a complete collapse of the system (opportunity to start over), or a combination of low hanging fruit short-term measures to address bureaucracy in the system and a Commission proposal for fundamental revision of MDR and IVDR. This would include in areas of governance, procedures (including orphan and innovative devices pathways) and changes to the five-year certification cycle in exchange for PMS surveillance.

The current regulatory framework is under heavy pressure to change to respond to some difficulties identified with the implementation of the MDR and IVDR. A first worry would be that the changes to the regulatory framework are done too quickly to consider all the impacts. Another worry could be that the requirements of highly skilled human resources expert in specific product codes could lead to shortages of auditors at notified bodies and thus to delay certifications of devices in general.

In my opinion, the two most urgent changes are to propose a dedicated expert structure (MDCG) to harmonize the designation and monitoring of notified bodies, classification issues, and common specifications among other matters and to reduce the administrative burden to the extent necessary, avoiding duplication of work while keeping in mind the main goal to assure patient safety.

By 2026, thanks to current initiatives, the European regulatory framework for medical technologies should have been modified to establish the bases for a rationale to allow the placing on the market of innovative, safe and effective devices for the greater good of patients.

I am worried most about the measures used to address the issues initiated with the implementation of the EU MDR and EU IVDR. Also, I am worried that we are moving backward instead of finding a lean, digital and patient-oriented system addressing the current needs of our EU population.

I think we should immediately start accepting e-labeling and e-IFU for all kinds of devices regardless of their classification. Also, we should stop spending time on bureaucratic tasks and focus our regulatory work on balanced and risk-based scientific evidence.

As a European patient and citizen, the biggest win that can be celebrated is the assurance of key device availability on the EU market. To achieve that, the EU legislation must be adopted to focus on patient needs which include timely access to innovative and well-performing devices.

What worries me most going into 2025 with regards to medtech regulatory issues are potential delays in implementing MDR and IVDR with returning bottlenecks as a result, ultimately causing stress in the healthcare system. These delays may come from uncertainty over socioeconomic situations, such as increasing inflation, ongoing military escalations, and more demanding expectations on data privacy and security. I am also concerned that the debates ongoing on a reform of the MDR governance, or more in-depth revision of the regulations, could cause projects on compliance to be put on hold, or at least slow them down.

As notified bodies now generally lack work, we might expect them to further decrease in size over the course of 2025. And this may result in undercapacity when finalizing certification projects picks up again.

Most urgent, therefore, in my view is to get more realistic insight into the scope and timelines of potential revisions. And secondly, I hope manufacturers will continue to implement the MDR and IVDR, utilizing currently available resources in the system, to support a smooth and functioning healthcare system which ensure sufficient devices are available to patients.

I believe that 2025 will bring some early changes to the medtech regulations that will reduce administrative burdens in the system, at the same time as creating pilot programs to stimulate innovation, SMEs and orphan devices.

In 2026, we may see the first elements of changes to the governance system, perhaps in a gradual way. As well as having initial improvements focus on special pathways for innovation, SMEs and orphan devices, we could also anticipate further streamlining, support and monitoring of notified body activities. Additionally, there could be streamlined guidance in a topic-centered bundle rather than in many different short documents.

I am concerned about heavy pressure on our legal framework, with the risk of too hasty changes and continued uncertainty about what amendments we will see when.

I also fear lack of consistent clarification of the requirements for MDR/IVDR compliance and hesitancy among regulators to use the legal instruments available to take decisions leading to legally binding clarification.

One important change would be a mechanism to certify innovative, orphan and breakthrough devices under the existing legal framework. A new MDCG Working Group on special pathways could be tasked with this by reviewing and issuing binding opinions on pre-certification reports by notified bodies. The working group consists of representatives of member states and utilizes existing expertise at the notified bodies. Proper support is essential for its success.

Additionally, we need a shift from document-centric to data-centric regulatory processes to foster a more agile and responsive regulatory environment. This would include integration of data from various sources (e.g., pre-market clinical investigations, post-market surveillance) to provide a comprehensive view of a device’s performance, leading to more informed regulatory decisions, as well as automated data collection and analysis to reduce the administrative burden for manufacturers and notified bodies and lead to faster and more efficient certification and surveillance processes.

We will likely be celebrating that the first five modules of Eudamed are in operation, leading to improved data transparency and device traceability. A lot of the current regulatory uncertainty will be addressed by utilization of existing mechanisms for legally binding decisions. We will have a clearer view on how the regulatory framework will evolve to create an agile, yet robust system for safe and effective medical devices for the EU citizens.