Revising the EU Medical Device Regulation: putting clinical expertise at the centre

The forthcoming revision of the Medical Device Regulation (MDR), expected to be finalised during Ireland’s Presidency of the Council of the EU, provides a key opportunity to strengthen collaboration between regulators and the clinical community.

Adopted in 2017, the MDR replaced previous directives with the aim of improving patient safety, supporting innovation, and reinforcing the role of clinical evidence in the approval of medical devices. It applies to a wide range of products, from basic medical equipment to complex implantable devices such as heart valves and stents. While the Regulation has modernised important aspects of the system, its implementation has also led to unintended consequences. In cardiology in particular, concerns have emerged regarding reduced access to certain devices and delays in bringing innovative technologies to patients.

Professor Elena Arbelo, member of the ESC Regulatory Affairs Committee, highlighted that the revision is therefore both timely and necessary. However, she emphasised that efforts to simplify procedures must not compromise patient safety. “Some risks only become apparent after years of use,” she noted, underlining the importance of grounding regulatory decisions in robust clinical data, including evidence generated through registries led by healthcare professionals.

Strengthening engagement with Expert Panels and Notified Bodies

Before reaching the European market, medical devices must obtain a CE mark from a Notified Body. These organisations, while highly experienced in regulatory assessment, often operate across a wide range of medical fields, meaning that specialised clinical expertise may vary.

Under the MDR framework, Expert Panels - supported by the European Medicines Agency - provide independent scientific advice on high-risk devices. The ESC is calling for more structured and continuous engagement between these Panels, learned societies, and Notified Bodies.

Early and ongoing input from clinical experts is particularly important for highly innovative or “orphan” devices designed for small patient populations. Ensuring transparency in decision-making, including feedback where expert advice is not followed, would also help align regulatory outcomes with clinical priorities and patient needs.

Balancing innovation and patient safety

A central issue in the MDR revision is how to balance faster access to innovation with the need for rigorous safety standards. One proposal involves reintroducing the concept of “equivalence”, allowing approval of new devices based on data from similar products already on the market. While this could reduce administrative burden, the ESC has raised concerns that removing existing safeguards may weaken patient protections - particularly for high-risk implantable devices, where small differences in design or materials may have significant consequences over time.

Similarly, proposals to allow indefinite certification of devices, removing the need for periodic re-certification, raise concerns about the long-term monitoring of safety and performance.

In this context, the ESC strongly supports a risk-based approach, ensuring that regulatory requirements remain proportionate to the level of risk associated with each device.

Towards a more coherent and sustainable system

The proposed revision also introduces measures to harmonise the reprocessing of medical devices across EU Member States, addressing current fragmentation in national approaches. While this could support sustainability by reducing medical waste, the ESC recommends that decisions on reprocessing should be assessed by Notified Bodies according to clear, EU-wide criteria developed in consultation with clinicians and healthcare providers.

Overall, the MDR revision represents an opportunity to refine the regulatory framework in a way that supports both innovation and patient safety. Embedding structured dialogue with clinical experts will be essential to achieving this balance.

As Professor Arbelo concluded, ensuring that regulatory decisions reflect clinical realities and patient outcomes must remain at the centre of the process - and the ESC stands ready to contribute to this effort.