The EU Medical Device Regulation (MDR 745/2017) was introduced to improve safety and support innovation in the European medical device sector. However, since its implementation, unintended consequences have emerged, particularly affecting patient access and innovation. The European Society of Cardiology (ESC) has raised significant concerns about the regulation's impact on the availability of vital devices, especially in specialised fields such as paediatric and orphan cardiology. In response, the ESC has outlined a series of recommendations aimed at revising the MDR to make it more functional, efficient and supportive of medical progress, while preserving patient safety.
Safeguarding Access and Expertise
One of the most pressing issues identified by the ESC is the disappearance of critical medical devices from the EU market. Nearly half of clinicians surveyed confirmed difficulties in accessing previously available devices, with paediatric cardiology among the hardest-hit areas. Despite emergency measures and the introduction of advanced withdrawal notifications, the current framework lacks a cohesive EU-level response to these shortages. The ESC recommends a responsive and transparent system for EU-wide derogations, including a formal assessment of the clinical impact of device withdrawals in consultation with patient and healthcare professional organisations.
The ESC also underscores the limited but promising role of expert panels introduced by the MDR. Initially tasked with providing advice on high-risk devices, these panels have begun offering scientific guidance through a pilot programme managed by the EMA. While helpful, the ESC advocates for the expanded and earlier involvement of these panels in regulatory processes. Their clinical input should also be used to define breakthrough or orphan device criteria and support notified bodies. Additionally, the ESC urges greater integration of healthcare professional organisations into regulatory structures such as the Medical Device Coordination Group (MDCG), to ensure practical, frontline insights are systematically included in guidance development.
Improving Governance and Encouraging Innovation
The ESC stresses the need for a more unified and coordinated regulatory architecture in Europe. The current decentralised system, involving national authorities and notified bodies, lacks the consistency and efficiency required for high-risk and rapidly evolving medical technologies. A central agency should coordinate clinical evidence generation, support product development from early stages and harmonise interactions with national regulators and notified bodies. Such coordination would streamline regulatory pathways while ensuring proportionate requirements for lower-risk devices and robust assessments for high-risk innovations.
Innovation has been particularly stifled by the regulatory burden imposed on new and legacy devices. The EU is seeing a marked decline in manufacturers prioritising its market, with decreases of 33% among large firms and 19% among SMEs. For legacy devices, required compliance with MDR for significant updates discourages iteration, slowing the adoption of newer, safer versions. To address this, the ESC proposes the introduction of priority pathways inspired by successful programmes in other jurisdictions. These would involve early stakeholder dialogue, clear eligibility criteria and active participation from expert panels, specifically targeting orphan, paediatric and breakthrough devices. Certificates with conditions could also be issued for products needing long-term clinical data, provided their immediate clinical value outweighs any risks.
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Enhancing Transparency and Clinical Evaluation
Data transparency and access to clinical evidence are core to ensuring device safety and fostering trust in the regulatory system. While the MDR aimed to improve this through the European Database on Medical Devices (EUDAMED), the delayed rollout of its clinical module has resulted in persistent information gaps. Healthcare professionals are unable to access essential data to evaluate the safety and effectiveness of marketed devices. The ESC calls for the acceleration of EUDAMED’s development and the establishment of a centralised reporting database to track real-world outcomes, especially for novel and off-label device use.
High-quality data collection must be backed by public funding and institutional support. This includes investing in European registries and clinical trials addressing unmet public health needs. Harmonised data standards and the integration of real-world data into the regulatory process are essential. These efforts should align with the European Health Data Space framework and extend to international collaborations. Within clinical evaluation systems, coordinated assessments of multi-country trials are a priority. Current approaches often involve inconsistent requirements across Member States, complicating trial management and delaying innovation. The ESC recommends greater harmonisation, including early advisory mechanisms with multidisciplinary expertise, mirroring pre-submission processes used elsewhere. This would build consistency and efficiency across Europe.
The EU Medical Device Regulation has exposed critical structural issues that compromise both patient care and innovation in cardiology and other medical fields. The European Society of Cardiology’s recommendations offer a constructive path forward, advocating for reforms that retain the regulation’s original intent while addressing its real-world shortcomings. From strengthening EU-wide coordination and expert involvement to streamlining access to high-need devices and enhancing clinical trial infrastructure, these proposals aim to restore confidence and efficiency in the European medical device landscape. By implementing these changes, the EU can better protect patient safety, stimulate innovation and uphold its commitment to high-quality healthcare.
Source: European Society of Cardiology
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