A strategic call for proposals to transform clinical research in France
Launched in 2023, the call for projects "Clinical investigation networks - medical devices and in vitro diagnostic medical devices" aims to structure clinical research in France by funding the creation and development of public and private investigation networks dedicated to medical devices as well as in vitro diagnostic medical devices.
This call for projects responds to the major issues revealed or accentuated by the health crisis, as well as to the application of the new European regulations MDR 2017/745 and IVDR 2017/746, which impose reinforced requirements in terms of device quality, safety and performance (find out more on our Context & Regulations page). Medical device manufacturers now face significant challenges in ensuring that their products comply with these stringent standards.
Panorama of the medical device industry in France: alarming figures from SNITEM 2023
According to the Panorama 2023 du secteur des dispositifs médicaux, published by SNITEM:
- Nearly 82% of companies have applied for MDR certification for existing products, but three-quarters have not yet obtained certificates.
- 21% of companies feel that the application of MDR threatens the sustainability of their production sites in France.
- 46% of companies surveyed have given up marketing a DM in France
- 79% of companies have incurred expenditure to comply with the new regulation for products already on the market; mobilizing up to 90% of R&D staff and generating a 54% increase in additional expenditure per product
- 46% of companies surveyed have given up marketing a DM in France.
Find out more here.
ANR meets the challenges of the French market
Despite a recognized and highly dynamic research and innovation ecosystem, France is struggling to capitalize fully on its domestic market. Faced with these observations, this call for projects appears to be a structuring solution for overcoming the current brakes and boosting innovation in the medical device sector in France.
A total of six projects were selected at the end of 2024 under the ANR call for projects with the objectives of:
✅ Encourage the conduct of clinical studies (pre- or post-CE mark) by supporting sponsors in the development, design and conduct of these studies;
✅ Create concrete bridges between hospitals, industry and start-ups to encourage collaborative projects and accelerate innovation;
✅ Strengthen the attractiveness of French clinical investigation networks and improve their positioning on European calls for projects
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REFeR-RYTHMO: at the heart of clinical research in interventional rhythmology
The award-winning REFeR-RYTHMO network, specializing in interventional rhythmology, is coordinated by Pr Frédéric Sacher, PU-PH at Bordeaux University Hospital and researcher at the Liryc IHU.
REFeR-RYTHMO aims to simplify access to clinical expertise and optimize patient recruitment in clinical trials. The network brings together 17 partner institutions involving 18 clinical departments, 4 Clinical Investigation Centers - Technological Innovation (CIC-IT) and 2 University Hospital Institutes.
With allocated funding of nearly €500k, this network operates in particular in the field of defibrillators, pacemakers and ablation devices. The REFeR-RYTHMO network represents a unique opportunity to strengthen collaborations between healthcare establishments and improve patient care through advances in rhythmology.
See the press release from Bordeaux University Hospital.
Our expertise
Pre-clinical expertise: Explore, test, refine
The network facilitates access to pre-clinical expertise and platforms conducive to experimentation, combining digital modeling, biological testing, functional analysis, ergonomics testing, biocompatibility validation...
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Clinical expertise: Evaluate, recruit, demonstrate
With 18 clinical departments, 4 CIC-ITs and 2 IHU REFeR-RYTHMO enables rigorous and rapid implementation of trials. Pilot studies, pivotal trials, targeted recruitment, patient follow-up and valorization of results: our expertise covers the entire clinical evaluation chain
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Post-market expertise: Optimize, monitor, valorize.
Marketing does not mark the end of the process. Post-market studies, real-life analyses, mobilization of medico-administrative databases (SNDS), and strategic support: we help you make a difference in the long term
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