Medical Device and Health Technology Evaluation Committee (CNEDiMTS*)
*The Medical Device and Health Technology Evaluation Committee is called CNEDiMTS in French.
1. Assess medical devices with CE marking when manufacturer submits an application for registration on the list of products and services qualfying for reimbursement (initial listing, renewal listing, new or extended indication) or when a reassessment is resquested by either the Ministry or the CNEDiMTS.
2. Provide recommendation for medical devices with respects to reimbursement by the National Health Insurance Fund and/or hospital use, through an assessment of their Actual Clinical Benefit (ACB) and likely Clinical Added Value (CAV) in comparison to available therapies.
3. Contribute to the proper use of medical devices by publishing relevant and independent scientific information on medical devices, including their intended role within a therapeutic strategy for a given disease.
The CNEDiMTS recommendations are used by public authorities in the reimbursement decision-making process. They also contribute to improving the proper use of medical devices by health professionnals and patients.
- Twenty-eight members with voting rights (21 full members, 7 substitutes), selected for their scientific expertise in various medical specialities ; including the chair (appointed among the Board members) and two vice-chairs.
Chair : Dr Isabelle ADENOT
Vice-chairs : Prof Claude LE FEUVRE, interventional cardiology, Paris and Dr Pierre-Jean BENEZET, physical medicine and rehabilitation, Marseille
Prof Philippe AMABILE, vascular surgery, Marseille
Prof Jean-Paul BEREGI, radiology, Nîmes
Dr Agnès BELLOCQ, pneumology, Paris
Prof Lionel BONNEVIE, cardiology, Clamart
Dr Didier BOUCCARA, ENT, Paris
Dr Philippe BREIL, visceral and digestive surgery, Paris
Dr Pierre-Yves CHAMBRIN, pharmacist, Paris
Mrs Dominique COSTAGLIOLA, methodology, Paris
Prof Henry COUDANE, orthopaedics, Nancy
Prof Pierre-Dominique CROCHET, radiology, Nantes
Dr Linda DARMON, physical medicine and rehabilitation, Clamart
Dr Romain DESCHAMPS, neurology, Paris
Prof Marie-Sylvie DOUTRE, dermatology, Bordeaux
Prof Béatrice DULY-BOUHANICK, diabetology, Toulouse
Dr Yves FRANCOIS, digestive surgery, Pierre-Bénite
Dr Laurence GIRARD, geriatrics, Paris
Pr Yves JUILLIERE, cardiology, Paris
Dr Bernard LENOIR, anesthesia and intensive care, Percy
Mr René MAZARS, member of patients and users association of health system mentioned in article L.1114-1 of the Public Health Code, Luc La Primauble
Mr Guillaume PELE, ergotherapy, Nancy
Prof Alain SAUTET, orthopaedics, Paris
Mr Pascal SELLIER, member of patients and users association of health system mentioned in article L.1114-1 of the Public Health Code, Fouquerolles
Prof Franck SEMAH, neurology, Lille
Prof Evanguelos XYLINAS, urology, Paris
- 8 members in an advisory role :
Representatives of the Social Security Directorate, the Directorate-General for Health, the Directorate-General of Care Provision, the National Health Insurance Fund, the French National Agency for Medicines and Health Products Safety, the Central Fund of Social Agricultural Mutual Benefit Societies and the Insurance Scheme for the Self-employed.
The CNEDiMTS members are appointed for a three-year term by decree, renewable twice.
Rules of Procedure
The Committee’s main task is to assess medical devices in order to provide recommendations on reimbursement decisions made by the public authorities. The Committee follows a set of rules and principles, defined by the Committee itself, which serve the members in reaching and issuing sound recommendations.
The Committee’s work is based on a regulatory framework, medical data, scientific methodology and sound reasoning, guided by the CNEDiMTS Rules of Procedure.
The standards applied to the assessment process take into account scientific and medical advances.
> The CNEDiMTS Rules of Procedure (in French only)
CE marking may be delivered at the European level by a notified body (except for some class I medical devices).
Access to reimbursement in France follows French Marketing Authorisation and requires manufacturers, distributors or service providers to submit an application dossier to the CNEDiMTS and to the Economic Committee of Healthcare Products (CEPS). The CNEDiMTS collaborates with Economic and Public Health Evaluation Committee (CEESP) when efficiency aspects are involved. The CNEDiMTS recommendation is then submitted to the CEPS to determine the rate and price. The final decision for registration falls under the jurisdiction of the Ministry of Health and is published in the Official Journal.
Issuing a recommendation on a medical device
General overview :
Analysis of the manufacturer's application dossier and of published literature by the Medical Devices Assessment Department at HAS with the drafting of a preliminary document ;
Assessment ot the benefit of a medical device by the CNEDiMTS : Actual Clinical Benefit (ACB) and Clinical Added Value (CAV) ;
Hearing phase during which the manufacturer may submit written observations or request a hearing with the CNEDiMTS ;
Issuing of the final recommendation to UNCAM, CEPS and the Ministry of Health with publication on the HAS website.
- Medical device assessment in France - Guidebook ( 1.95 MB) Listen
- Guide for manufactors and distributors 2012 ( 202.28 KB) Listen
- Methodological Choices for the Clinical Development of Medical Devices ( 267.54 KB) Listen
- Guide to the specific feactures of clinical evaluation of connected medical device (CMD) in viewof its application for reimbursement ( 240.49 KB) Listen