French National Authority for Health released the evaluation principles for digital medical devices

Since 2023, France has offered two reimbursement pathways for certain digital medical devices (DMN): standard reimbursement via the list of medical telemonitoring activities (LATM) and advanced reimbursement for therapeutic and telemonitoring digital medical devices (PECAN).

On September 10, 2025, the HAS published the evaluation principles for digital medical devices, considered by the National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) when assessing reimbursement applications. HAS has also published reimbursement pathway guides for LATM and PECAN and infographics. The aim was to provide benchmarks to stakeholders by explaining CNEDiMTS's reasoning, based on the required criteria. The two guides illustrate multiple practical cases to support manufacturers in preparing applications, anticipating the CNEDiMTS's expectations. 

The HAS also updated the CNEDiMTS evaluation principles for other reimbursement pathways for medical devices for individual use, such as the List of Reimbursable Products and Services (LPPR) and the list of health products financed under hospitalization services known as the Intra-DRG (Intra-GHS) List (update the guide of 2018), and for medical devices eligible for transitional support (PECT) (update of the guide published in 2022).

See the details in French here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.