[2025-07-01] The Haute Autorité de Santé (HAS) website, which provides information on the evaluation of medical devices (MDs) for reimbursement purposes, was updated on July 1, 2025 with the publication of 4 separate volumes on reimbursement.
The Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS) therefore proposes four volumes according to the different evaluation criteria for each reimbursement route.
The first two volumes deal with standard coverage schemes:
- Volume 1 – Coverage via the List of Reimbursable Products and Services (LPPR for “Liste des Produits et Prestations Remboursables”) or the intra-GHS positive list (GHS for “Groupes Homogènes de Séjour”)
- Volume 2 – Coverage via the List of Medical Telemonitoring Activities (LATM for “Liste des Activités de Télésurveillance Médicale”)
The other two volumes are devoted to exceptional coverage schemes:
- Volume 3 – Transitional coverage (PECT for “Prise En Charge Transitoire”)
- Volume 4 – Anticipated coverage (PECAN for “Prise En Charge Anticipée”)
Each volume presents contextual elements adapted to the assessment route.
- The regulatory framework for the reimbursement of medical devices and other healthcare products,
or
- The regulatory framework for reimbursement of remote medical monitoring activities,
or
- Transitional coverage,
or
- Anticipated coverage.
It then describes the general principles of evaluation by the CNEDiMTS, as well as the criteria for judging the evidence provided by manufacturers.
Each also specifies the strong points or points to watch out for in a file, and places particular emphasis on anticipating strategy, which is a key element, whatever your route to coverage.
Each volume also presents the support available from the HAS:
- Pre-deposit appointment ;
- Early meetings.
Finally, with the exception of Volume 1, they all feature a useful toolbox in their appendices.
In conclusion, all the information you need to understand the evaluation of your medical devices is provided, whether you have a MD or a Digital MD (DMD), and whatever their type of coverage.
Article written by Axelle Cressenville, member of the DMEXPERTS network.