Health technology assessment of medical device in France
The French National Health Authority (HAS, Haute Autorité de Santé) is an independent health technology assessment body in charge of technical and clinical assessment of pharmaceuticals, medical devices and medical procedures, establishment of good practice guidelines and certification of health care organizations.
The HAS Medical Devices and Health Technologies Commission (CNEDiMTS, Commission Nationale d’Evaluation des Dispositifs Médicaux et des Technologies de Santé) is in charge of medical and technical assessment of medical devices and of procedures and services associated with their use.
Generic categories
No product-specific medical or technical assessment is required for using existing generic categories. Choice of the appropriate generic category and compliance with its technical specifications are under manufacturer’s responsibility. Inappropriate use of generic categories is punishable by fines. Generic categories and their technical specifications are subject to regular medical reviews by the HAS.
Brand-specific reimbursement
Medical assessment by the HAS is mandatory for any brand-specific registration on the positive reimbursement list. The CNEDiMTS commission gives its opinion on the medical value (SA or SR), the level of added medical value (ASA or ASR) in comparison to existing reimbursed alternatives, and estimates the target population eligible for reimbursement by the National Insurance.
The medical value (SA or SR) is noted as “sufficient” or “insufficient” for reimbursement by the National Insurance.
Unless the medical value is considered to be insufficient for reimbursement, the CNEDiMTS commission gives its opinion on the added medical value (ASA or ASR) with regards to alternative therapeutic options available in France, as well as on the target population that should benefit from the reimbursement (may be restricted to a subset of the CE mark indication).
The added medical value is rated on the 5-grade scale from “major” to “no” added value” compared to alternative options, on the basis of clinical data provided by manufacturer. Requirements in terms of level of evidence and clinical trial design vary depending on type of medical device, aim of its use and potential safety concerns. Post-registration real-world evidence studies are increasingly required, especially for implantable medical device.
When use of medical requires a specific medical or nurse procedure, the procedure should be registered on the positive list of reimbursable procedures (NGAP or CCAM classification). If medical device requires registration of a new medical procedure, both medical device and new procedure reimbursement applications should be assessed by the CNEDiMTS commission. Manufacturer is responsible for filing medical device reimbursement application. Procedure’s application can be submitted only by health care professionals organizations and scientific societies.
Medical devices used in home care often require associated home care services (delivery, installation, maintenance etc). Such services are assessed by the same CNEDiMTS commission in order to be reimbursed by the National Insurance.
Updated on December 15th, 2016