On 15 September 2025, the CORE-MD (Coordinating Research and Evidence for high-risk Medical Devices) consortium published new expert recommendations in The Lancet Regional Health Europe on how to improve clinical investigations of high-risk medical devices in the EU.
The report is a key outcome of the CORE-MD project, which the BioMed Alliance contributed to as a partner and which concluded in 2024. The recommendations aim to address significant gaps in the evaluation of high-risk technologies, including cardiovascular implants, orthopedic devices, and diabetes management systems.
Key recommendations 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.
The full article is available here: https://www.thelancet.com/journals/LANEPE/article/PIIS2666-7762(25)00252-2/fulltext
