Recommendations for Clinical Investigations of High-Risk Medical Devices in Europe Published by CORE-MD

September 16, 2025—The European Society of Cardiology (ESC) announced that CORE-MD, the Coordinating Research and Evidence for high-risk Medical Devices consortium, published new consensus recommendations by Professor Alan G. Fraser, MD, et al in The Lancet Regional Health Europe that set out scientifically robust methodologies for clinical investigations of high-risk medical devices.

According to ESC, these recommendations respond directly to a request from the European Commission to provide expert advice on trial design and address a longstanding gap in guidance for the evaluation of high-risk technologies such as cardiovascular implants, orthopedic devices, and systems for managing diabetes.

The press release noted that unlike medicines, which must demonstrate safety and efficacy before market entry, high-risk medical devices in Europe are required to provide only “sufficient clinical evidence,” which is a standard that is not defined in detail.

The CORE-MD analyses confirm that many devices have entered the market without robust evidence from randomized trials, often with little or no data in the public domain.

As outlined in the ESC press release, key recommendations from CORE-MD include the following:

• A four-stage framework for clinical investigations, from initial studies to long-term follow-up.
• Greater use of randomized controlled trials, including sham-controlled trials with appropriate ethical safeguards.
• Efficient large-scale trials embedded in registries to accelerate evidence generation.
• Mandatory transparency of study design, protocols, and results.
• Tailored approaches for breakthrough or orphan devices, requiring post-market confirmatory studies.

“These recommendations provide a clear scientific foundation for the evaluation of high-risk medical devices in Europe,” commented Prof. Fraser, Coordinator of the CORE-MD project, in the ESC press release. “Unlike the European Medicines Agency or the US Food & Drug Administration, which utilize regulatory science, the European Union framework has relied in the past on legal interpretation rather than clinical principles. By setting out a hierarchy of methodologies, we can now help developers, regulators and clinicians implement strategies that deliver robust, transparent, and patient-relevant evidence.”