CORE-MD

Manufacturers of medical devices are required to thoroughly test their products before receiving approval to place them on the market. Specifically, they must provide robust clinical evidence demonstrating that their devices are safe, effective, and reliable for patient use. This is particularly crucial for high-risk medical devices, where failure or misuse could have serious consequences for patients’ health and safety.

In this regulatory context, the CORE-MD (Coordinating Research and Evidence for Medical Devices) project plays a key role. It aims to translate expert scientific and clinical insights on the design of studies evaluating high-risk medical devices into structured, evidence-based recommendations for European regulatory authorities. The project’s ambition is to help modernise and strengthen the regulatory science framework for medical devices in Europe by providing clear, consensus-driven guidance on clinical evaluation standards.

CORE-MD represents a unique and wide-reaching collaboration that brings together a diverse range of stakeholders: leading medical associations, European regulatory agencies, notified bodies, academic and research institutions, patient advocacy organisations, and health technology assessment (HTA) agencies.

This multidisciplinary consortium is working to:

• Systematically review and analyse current methodologies used for the clinical investigation of high-risk medical devices;
• Identify and recommend innovative trial designs that can complement or improve traditional approaches, particularly in cases where randomised controlled trials may not be feasible;
• Advise on the integration of real-world evidence, by exploring how data collected from medical device registries and routine clinical practice can be aggregated and used in regulatory decision-making.

One of CORE-MD’s key strengths lies in its scientific leadership. The project is co-led by two major European medical societies: the European Society of Cardiology (ESC) and the European Federation of National Associations of Orthopaedics and Traumatology (EFORT). It also involves all 33 specialist medical societies that are members of the Biomedical Alliance in Europe, representing a broad spectrum of medical expertise across disciplines.

Through its collaborative approach and commitment to scientific rigour, CORE-MD is helping to shape the future of medical device evaluation in Europe, ensuring that innovation in healthcare continues to be supported by robust, transparent, and patient-centred clinical evidence.

WISE role:

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‍THIR PARTY – Wise Angle is in charge of the operational project management on behalf of the European Society of Cardiology (ESC)