Assessment of medical devices
Assessment of medical devices at HAS
HAS is responsible for providing recommendations, largely with regards to reimbursement of medical devices ; the latter falling withing the jurisdiction of the Medical Device and Health Technology Evaluation Committee (CNEDiMTS).
> Learn more about the medical devices assessment process at HAS.
> Submit an assessment dossier for a medical device (in French).
> Consult the guidance for submission and proceeding of an early dialogue (in French).
> Consult the guidance for submission and proceeding of a pre-submission appointment (in French).
Recommendations on medical devices
The CNEDiMTS recommendations are nonbinding and do not predict the Ministers decisions in terms of reimbursement.
A recommendation generally includes :
- an evaluation of the Actual Clinical Benefit (ACB) to ensure legitimate listing of a medical device,
- a comparison of the medical device ACB with the reference therapeutic strategy,
- an evaluation of the Clinical Added Value (CAV) provided by a medical device in relation to it(s) comparator(s),
- a re-evaluation of the medical device CAV for registration renewal.
> See the opinions on medical devices (in French)
> See the opinions on medical devices (in English)
Health technology assessment reports
For some medical devices, an assessment report is prepared by HAS and the CNEDiMTS delivers its recommendations about these products. This report describes :
- the context of the assessment,
- the working method,
- the analysis of the literature carried out,
- the opinion of the professionals sought.