[2025-09-16] On September 16, 2025, the CORE-MD (Coordinating Research and Evidence for Medical devices) consortium published an article in The Lancet Regional Health – Europe detailing their recommendations for the clinical investigation of high-risk medical devices (MDs).
This is a 14-page (scientific) article, including bibliography, entitled “Recommended methodologies for clinical investigations of high-risk medical devices – Conclusions from the European Union CORE-MD Project” (Alan G. Fraser and al.). Its publication was also the subject of a press release on the website of the ESC (European Society of Cardiology), which manages CORE-MD.
Context
The CORE-MD consortium was originally a project funded by the European Union as part of the Horizon 2020 program. This project, launched in 2021, was the subject of a previous network article. Its main objective is to provide European authorities with advice based on scientific and medical evidence, in order to evaluate high-risk medical devices. This covers class IIb and class III devices, with a particular focus on cardiovascular and orthopaedic devices. These recommendations are a direct response to a request from the European Commission, aimed at guiding and improving European regulations.
Report
CORE-MD notes a difference in treatment between drugs and medical devices. Medicinal products must demonstrate their safety and efficacy before market access. On the other hand, high-risk medical devices in Europe are only required to provide “sufficient clinical evidence”, a concept that is not sufficiently defined.
Through its analyses, CORE-MD confirms that many MDs have reached the market without solid evidence from randomized trials, often with little or no publicly available data.
Recommendations
In summary, CORE-MD’s key recommendations for MDs clinical investigations include:
- a four-stage framework for clinical investigations, from initial studies to long-term follow-up;
- increased use of randomized controlled trials, using either active comparators representing the best possible treatment, or placebo-controlled trials (sham-controlled trials), with appropriate ethical safeguards;
- non-randomized studies can be based on objective performance criteria or other validated measures relevant to patients, with adjustments to reduce bias;
- the use of databases or an electronic registry for efficient management of large-scale clinical trials;
- total transparency, from study design and protocols to results;
- approaches adapted to innovative (breakthrough) or orphan MDs, enabling initial approval with fewer data, subject to post-marketing confirmatory studies.
By way of illustration, figure 1 in the article offers a comparison of different terminologies for clinical investigations of new drugs or MDs :
It explicitly shows CORE-MD’s four-step framework recommendation, represented on the line with their logo (the blue asterisk). We can also see how terms differ between the different texts used as references for MDs.
Application examples
In the article, CORE-MD gives detailed examples of objectives, as well as study design recommendations for each stage.
In addition, two other tables illustrate a risk- and evidence-based approach, adapted according to the level of innovation and the clinical context of the device. They repeat the four-step structure:
- Table 4: Cases of innovative or orphan devices with little initial evidence, with emphasis on post-market data collection
- Table 5: Cases of devices similar to existing devices, requiring rigorous evidence, preferably with randomized controlled trials
Like all articles published in the scientific literature, this one is rich and dense in information. If you are interested in this subject, we invite you to read it in detail.
Conclusion
The recommendations have since been forwarded to EU regulators for review. The aim is to incorporate them into future
Article written by Christophe Saillet, member of the DMEXPERTS network.