Improving the regulatory framework

Medical devices

The Medical Device Regulation
Medical Devices in the EU are regulated under the Medical Device Regulation (MDR), introduced in 2017 with the stated ambition of significantly raising the standards for quality and patient safety across Europe. Throughout the legislative process, the ESC proactively engaged with EU policymakers, advocating for measures aimed at improving regulatory standards and patient safety, including the establishment of a centralised regulatory agency at the EU level—a recommendation that was ultimately not included in the final text.

Since its full implementation in 2021, the MDR has encountered considerable criticism due to unintended disruptions within the medical device market, resulting in the withdrawal of essential medical products and creating challenges for healthcare providers, manufacturers, and patients alike. These disruptions prompted the European institutions to introduce multiple corrective measures to address these criticalities. In this context, the ESC actively supported the European Commission by providing expertise and insights from the cardiovascular community, notably through its position as an observer within the Medical Device Coordination Group (MDCG). In this role, ESC representatives contributed directly to the drafting and revision of essential guidance documents, including guidance related to orphan medical devices, and highlighted issues particularly relevant for cardiovascular patients and healthcare professionals.

CORE-MD
In addition, the ESC has led an EU-funded Horizon 2020 project called CORE–MD. The initiative developed evidence-based recommendations aimed at supporting EU regulators in striking an optimal balance between innovation, patient safety, and clinical effectiveness. More information about CORE–MD’s objectives and key deliverables is available here.

The upcoming revision
In December 2024, the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) launched a targeted evaluation of the MDR, calling upon stakeholders to provide detailed insights into the strengths and weaknesses of the current regulatory system.

Besides providing its feedback to the Targeted Evaluation in March 2025, the ESC published a Policy Statement outlining the cardiovascular community’s priorities for the revision of the MDR. The statement reiterates the need for enhanced regulatory centralisation, broader engagement of healthcare professionals, expanded mandates for expert panels, greater clarity regarding the regulation of digital health technologies and artificial intelligence, and improved support mechanisms for devices addressing unmet medical needs. The full ESC policy statement outlining these priorities can be accessed here.

The ESC continues to engage closely with decision-makers, and other stakeholders, advocating persistently for a balanced, patient-centric regulatory framework ensuring continued access to essential and innovative medical devices.

Pharmaceuticals

The ESC is a member of the European Medicines Agency (EMA) Healthcare Professionals’ Working Party (HCPWP), which provides a platform for the exchange of information and discussion on issues of common interest between the Agency and healthcare professionals.

Reform of the EU Pharma Legislation
The European co-legislators are discussing a comprehensive reform of the regulatory framework for medicines in the Union. The ESC has been continuously engaging with key decision makers and stakeholders to provide the perspective of the cardiovascular community, and to advocate for a structural involvement of Healthcare Professionals in the regulatory system, for example in the definition of Unmet Medical Needs.

In a policy statement published in May 2024, the ESC has welcomed several of the modifications proposed by the European Parliament, calling on the Council to uphold these while addressing some remaining issues.

Medicines shortages
The European institutions and regulators undertook several initiatives in response to widespread reports of medicines shortages following the pandemic crisis, such as the Critical Medicines Act. The ESC is closely monitoring these initiatives and engaging in constant dialogues with regulators, institutions and stakeholders with the objective of ensuring continuity of supply of critical cardiovascular medicines.

Digital health

European Health Data Space
The European Health Data Space, (EHDS) is an ambitious European Union regulation that entered into force on 26 March 2025. Its primary goal is to facilitate the secure and efficient exchange of health data across Europe, supporting and enhancing healthcare delivery (primary use) as well as enabling health research, innovation, and evidence-based policy-making (secondary use).

Recognizing the transformative potential of health data to drive digital health innovations and improve cardiovascular healthcare outcomes, the ESC has actively engaged with policymakers from the initial stages of the EHDS proposal. The know-how gathered in the development of our cardiovascular registries was leveraged to provide expert knowledge to key decisionmakers, while emphasizing the pivotal role healthcare professionals will play in successfully implementing and operationalizing this new European framework

At the same time, the ESC has engaged with a wide array of stakeholders in the EU health ecosystem to underscore the need for continuous dialogue in the implementation of the EHDS, most notably through the soon-to-be-established EHDS Stakeholder forum. We look forward to the possibility of contributing to the Stakeholder forum, in direct continuity with our current and past involvement in the European Commission’s eHealth Stakeholder Group. Nevertheless, we remain aware of the challenges that implementing such an ambitious data-sharing initiative, and we are advocating for the need to establish a harmonized approach to the EHDS, coherent throughout all Member States, to unlock its true potential.

Artificial Intelligence
Artificial Intelligence (AI) is undoubtedly going to transform clinical practice and provide new tools and methods to advance healthcare across all domains, including cardiovascular care. Ensuring that the regulatory framework is fit to address the risks and opportunities peculiar to AI in healthcare is one of the priorities of the ESC.

For this reason, the ESC has closely followed the discussions on the EU Artificial Intelligence Act, and it has organized an event titled “AI: from regulation to applications in the cardiovascular field”, where some of the key decision makers working on the topic discussed  challenges and opportunities for AI in healthcare, starting from several examples of implementation in diagnostic imaging and decision making.

The CORE-MD consortium, led by the ESC, has extensively discussed regulatory implications of the AI in healthcare, and has recommended the adoption of common standards for the clinical evaluation of high-risk AI applications, calling for transparency for what concerns their evidence and performance.

Health technology assessment

Health technology assessment (HTA) measures the added value of technology compared to existing ones. It provides objective information on the safety and clinical effectiveness of health interventions so that policymakers can allocate their resources judiciously. According to the Health Technology Assessment regulation, a common framework for HTA will be available to EU member states by January 2030.

The ESC has provided extensive advice to the design of this common framework through its participation to the European Network for Health Technology Assessment (EUnetHTA), and it regularly participates to the meetings of the Health Technology Assessment Stakeholder Network organized by the European Commission.