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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).

> Learn more about the Guide to the specific feactures of clinical evaluation of connected medical device (CMD) in viewof its application for reimbursement

> 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. 

All CNEDiMTS recommendations on medical devices are written in French (official language). Some of them are translated in English.

> 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.

> See the health technology assessments 

Posted on Nov 27 2015