National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS*)

Missions

The National Committee for the Evaluation of Medical Devices and Health Technologies (Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé, CNEDiMTS) examines questions relating to the evaluation of certain medical devices, medical procedures and other health technologies, with a view to their reimbursement by the health insurance scheme, and to their proper use.

More specifically the CNEDiMTS:

• Assesses requests for registration on the reimbursement list (Liste des Produits et Prestations Remboursables, LPPR) of medical devices for individual use and other products with a therapeutic, diagnostic or disability compensation purpose (excluding medicinal products) as well as associated services.
• Evaluates requests for early access for presumably innovative medical devices with a therapeutic or disability compensation purpose and falling within the scope of the LPPR (Prise en charge transitoire, PECT).
• Evaluates remote medical monitoring (liste des activités de télésurveillance médicale - LATM) and assesses requests for early access for digital medical devices (prise en charge anticipée d’un dispositive médical numérique - PECAN).
• Evaluates certain categories of medical devices financed as part of hospital services (Intra-GHS).
• Examines all other issues relating to the assessment and proper use of medical devices and health technologies, including those financed as part of hospital services.
• Gives opinion on the conditions for registration of procedures and their inclusion in the Common classification of medical procedures (Classification Commune des Actes Médicaux, CCAM), as well as their removal from this list
• Develops information documens for healthcare professionals

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 professionals and patients.

Composition 

• Twenty-nine members with voting rights (22 full members, 7 substitutes), selected for their scientific expertise in various medical specialties and two representatives of patient associations and healthcare users; 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.   

Members are appointed for a three-year mandate, renewable twice. The current Chair of the committee is Dr Grall.

Rules of Procedure

The Committee follows a set of rules and principles, defined by the Committee itself, which serve the members in reaching and issuing appraisals.

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 consider scientific and medical advances.

> The CNEDiMTS Rules of Procedure (in French only)

An example of assessment process: registration on the LPPR list for a medical device

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 requires companies to submit a dossier to HAS which is responsible for Health Technology Assessment following the granting of a CE marking. The clinical assessment and appraisal of these dossiers is performed by the CNEDiMTS, the economic assessment  (when required) is performed by the Economic and Public Health Evaluation Committee (CEESP - Commission d'évaluation économique et de santé publique). The CNEDiMTS recommendation is then submitted to the Economic Committee of healthcare products (CEPS) for the pricing negotiation. The final decision for registration of the reimbursement list falls under the jurisdiction of the Ministers of Health and of Social Security 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 division at HAS with the drafting of a preliminary document;
• Assessment of the benefit of a medical device by the CNEDiMTS : Clinical Benefit (CB) 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.