Key takeaways

  • The European Society of Cardiology welcomes the proposed revision of the EU Medical Device Regulation as a vital step to restore the balance in addressing the challenges between safe patient access and innovation.
  • The ESC supports stronger clinical expertise and transparency in regulatory decisions, ensuring expert input is central to device assessment and monitoring.
  • Coordinated EU action is needed to prevent device shortages and maintain access to essential technologies, especially for vulnerable groups, without compromising safety or evidence standards.

Sophia Antipolis, France – 29 April 2026: The European Society of Cardiology (ESC) announced today that it welcomes the European Commission’s proposal to revise the EU Medical Device Regulation (MDR), recognising this as a timely and important step to address the structural challenges that have emerged since the Regulation entered into application.

The MDR was introduced to strengthen patient safety and improve the quality of clinical evidence. However, its implementation has also led to unintended consequences, such as reduced availability of medical devices, increased regulatory burden, fragmentation in evidence requirements, and a decline in Europe’s attractiveness for medical device innovation all of which impedes patient access to medical devices that save lives and greatly improve quality of life.

Professor Piotr Szymanski, Chair of the ESC Regulatory Affairs Committee said; “The proposed revision offers an opportunity to restore balance, ensuring that the EU regulatory framework remains protective of patient safety and supportive of innovation, while remaining at the effective service of patients.”

Enhancing Clinical Expertise in Regulation

The Commission’s proposal is expected to improve the functioning and predictability of the system, while also identifying targeted refinements needed to support timely patient access to safe and high-quality medical technologies.

Prof. Szymanski said; “We strongly support provisions that reinforce EU-level coordination and the role of expert panels, including earlier and more meaningful dialogue on clinical development strategies, high-risk devices, and innovation pathways. Systematic involvement of clinical perspectives and know-how through expert panels is essential to safeguard patient safety and support responsible innovation.”

At the same time, the ESC also emphasises the need for greater transparency and operational clarity on how expert-panel opinions are reflected in notified bodies’ final decisions, to avoid misalignment between scientific input and regulatory outcomes, with Prof. Szymanski highlighting; “Meaningful stakeholder participation, including the collective expertise of healthcare-professional organisations throughout regulatory assessment and approval, is essential to ensure safe and effective access to innovative medical devices.”

Preventing Device Shortages and Safeguarding Access

The ESC welcomed the Commission’s efforts to address device shortages, but underlines that notification obligations alone are insufficient without a coordinated EU-level response mechanism. Clinicians and healthcare institutions, who experience shortages first-hand, playing a central role in ensuring continuity of care for patients should have a stronger role in shortage detection, impact assessment and mitigation.

The ESC also calls for a clinically led, rapid-response approach to essential devices at risk of withdrawal, supported by EU-wide coordination and meaningful involvement of healthcare-professional organisations. Ensuring continuity of care is particularly critical in paediatric and orphan indications, where alternatives are often limited.

Supporting Innovation While Preserving Safety

The ESC Statement supports the intention to reduce the unnecessary administrative burden and introduce more proportionate pathways for breakthrough and orphan devices. However, it also highlights that simplification need not come at the expense of robust clinical evidence or long-term safety monitoring. Strong real-world evidence generation, including through clinical registries, remains essential to a risk-based, adaptive and patient-centered regulatory framework.

Prof. Szymanski said; “Europe needs a robust, independent system for medical device data collection to protect patients and strengthen oversight. With only a minority of EU registries publicly funded, sustained investment in high-quality evidence is essential to support proportionate regulation, uphold safety and quality, and speed patient access to meaningful innovation.”

Finally, the ESC supports an expanded coordinating role for the European Medicines Agency in areas such as expert-panel governance, regulatory sandboxes and cross-border consistency, as a step towards a more coherent and predictable EU system.

ENDS