The European Society of Cardiology (ESC) has urged the European Commission to revise the Medical Device Regulation (EU 745/2017, MDR) following significant challenges in its implementation.
While the MDR was designed to enhance the safety and quality of devices within the European Union, increased regulatory complexity and high certification costs have inadvertently reduced the availability of vital medical devices, especially for vulnerable populations. Other problems include the limited involvement of clinical experts, the lack of a centralised governance, the absence of special regulatory pathways and the shift of innovation towards other markets.
Despite temporary measures to extend transition periods, the need for more comprehensive provisions has become apparent and called for also by the European Parliament ( Resolution 2024/2489 ) and several Member States.
The ESC praises the initiative undertaken by the European Commission to assess the drawbacks of the current regulatory framework by widely consulting stakeholders as part of its Targeted Evaluation of MDR.
As observed by Prof. Piotr Szymanski, Chair of the Regulatory Affairs Committee of the ESC: "From the definition of criteria for priority pathways to methodological guidance for clinical evidence generation, the involvement of healthcare professionals will be fundamental to ensure a safe and effective regulatory framework for medical devices".
As part of its response to the public consultation, the ESC has published a policy statement that outlines key priorities and gives concrete recommendations to improve the current regulatory framework and enhance patient access to safe, high-quality and innovative devices.
- Protecting access to "disappearing devices": Implement a clear, responsive policy for issuing EU-wide derogations, including an assessment of the impact of device withdrawals on clinical practice, in close cooperation with patients' and healthcare professionals' organizations.
- Expanding the use of clinical expertise: Extend the role of expert panels earlier in the regulatory process to provide advice on clinical assessments and involve healthcare professional organizations in developing guidance and specifications.
- Enhancing the governance of the regulatory framework: Entrust a single Agency with the task of coordinating clinical evidence generation, working in conjunction with national authorities and notified bodies to ensure high-quality clinical trials and streamlined approval for lower-risk devices.
- Tackling the technology gap: Introduce special regulatory pathways for breakthrough, orphan and paediatric devices, with clear eligibility criteria and early dialogue between developers, regulators, and healthcare professionals.
- Improving transparency and data availability: Strengthen data collection and ensure the establishment of a functional data infrastructure at the EU level to facilitate post-market surveillance and monitor medical device safety and performance. Public funding to support European registries should also be ensured to leverage the full potential of Real World Data and in line with the EHDS implementation.
- Improving the clinical trial eco-system for cardiovascular devices: Enhance coordination of multi-state clinical investigations across the EU and establish clear early advisory mechanisms, supported by healthcare professionals and regulatory experts.
- Impact on AI and Digital Health innovations: Clarify regulatory requirements for AI-enabled medical devices within the MDR and establish a unified European framework for evaluating clinical evidence, promoting innovation while maintaining safety standards.
- Reprocessing of medical devices: Promote a harmonized approach to the safe reprocessing of medical devices across EU Member States, ensuring patient safety while reducing environmental impact.
The ESC emphasises the need for an inclusive dialogue with healthcare professionals throughout the process and looks forward to continuing its engagement with EU institutions and stakeholders to ensure the MDR revision supports Europe's healthcare systems, professionals, and most importantly, patients.
