Medical Device and Health Technology Evaluation Committee (CNEDiMTS*)
- 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.
- 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.
- 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-nine members with voting rights (22 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.
- 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.
- Assessment principles established by CNEDiMTS to determine the reimbursement eligibility of medical devices for individual use
- Guide Methodology for the clinical development of MD
- Guide to the specific feactures of clinical evaluation of connected medical device (CMD) in view of its application for reimbursement
- Preparatory report of the guide to specific features of clinical evaluation in view of its application for reimbursement
- Dossier submission to the Medical Device and Health Technology Evaluation Committee (october 2020)
- GUIDE Pathway of Medical Devices in France