The CORE-MD (Coordinating Research and Evidence for high-risk Medical Devices) consortium is publishing new consensus recommendations in The Lancet Regional Health Europe , that set out scientifically robust methodologies for clinical investigations of high-risk medical devices.
These recommendations1 respond directly to a request from the European Commission to provide expert advice on trial design, addressing a longstanding gap in guidance for the evaluation of high-risk technologies such as cardiovascular implants, orthopaedic devices, and systems for managing diabetes.
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” – a standard that is not defined in detail. The CORE-MD analyses confirm that many devices have entered the market without robust evidence from randomised trials, often with little or no data in the public domain.
Key recommendations from CORE-MD include:
- A four-stage framework for clinical investigations, from initial studies through to long-term follow-up.
- Greater use of randomised 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.
Professor Alan Fraser, Coordinator of the CORE-MD project, said: “These recommendations provide a clear scientific foundation for the evaluation of high-risk medical devices in Europe. Unlike the European Medicines Agency or the US Food & Drug Administration, which utilise regulatory science, the EU 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.”
The CORE-MD consortium – funded by the EU Horizon 2020 programme, and led by the European Society of Cardiology (ESC) with the Federation of National Societies of Orthopaedics and Traumatology (EFORT) – brought together 100 leading academic trialists, clinicians, regulators, patients, and health technology assessment experts across Europe. Its findings have already informed proposals for reform of the EU regulatory system from the Biomedical Alliance in Europe, representing 35 medical societies.
The President of the ESC, Professor Thomas Lüscher, commented: “The European Society of Cardiology welcomes these new recommendations from the CORE-MD Consortium on the design and requirements for clinical investigations of high-risk medical devices in Europe. Convincing data on the efficacy and safety of new devices, ideally based on randomised clinical trials, are crucial for their use in patients with heart disease. We learned from trials of devices for high blood pressure that using sham controls can be most insightful. Surveillance of devices provides important information during clinical follow-up, so it is a major strategy of the European Society of Cardiology through its international registries such as GRASP and EuroHeart.”
The recommendations have been submitted to European Union regulators for consideration in future guidance on medical device clinical evaluation. A central challenge now will be ensuring their implementation within the EU Medical Device Regulation framework to safeguard patient safety while supporting innovation.
Reference
1. Fraser AG, Buccheri S, Byrne RA, Kjaersgaard-Andersen P, James S, Jüni P, Bally L, Bulbulia R, Koletzko BV, Landray MJ, Louati C, Lübbeke A, Marang-van de Mheen PJ, McCulloch P, Patro-Golab B, Rademakers FE, Schnell-Inderst P, Siontis GCM, Torre M, Wild C, Zeisl Y, Melvin T, Nelissen RGHH; on behalf of the CORE–MD consortium. Recommended methodologies for clinical investigations of high-risk medical devices – Conclusions from the European Union CORE–MD Project. The Lancet Regional Health Europe. 2025. (E-pub] doi: 10.1016/j.lanepe.2025.101460 https://www.thelancet.com/journals/LANEPE/article/PIIS2666-7762(25)00252-2/fulltext
