Connected medical devices

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in October 2023. Twelve recommendations were published in relation to the registration of medical devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, e-health, endocrine, gastrointestinal, neurology and neurosurgery, neuromodulation, and orthopedic devices, as well as medical aids.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in January 2023. Twenty-four recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular and peripheral vascular, neurovascular, and orthopedic devices, in-vitro diagnostics, as well as medical aids.

On May 09, 2022, the updated List of Reimbursable Products and Services (LPPR) was published. It contains new devices included in the LPPR list in April 2022, as well as other modifications made during this period. New devices that were introduced in the LPPR list belong to the endocrine and gastrointestinal technology groups.

In late October 2021, the Treatment Council (Behandlingsråd) published three topics chosen for developing the so-called major analyses (større analyser) in 2022. The selected topics include patient-centered diabetes technology, hand-held focused ultrasound in emergency medicine, and artificial intelligence as decision support for colonoscopy.

In early January 2020, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA24 “The 24-hour blood pressure measurement device Mobil-O-Graph® with the built-in pulse wave velocity algorithm ARCSolver® to measure arterial stiffness for the optimization of hypertension treatment and assessment of cardiovascular risk”.

In mid-February 2019, the French High Authority for Health (HAS) has published the new guideline to clinical evaluation of connected medical devices in France.

The meeting Improvement of Patient Quality of Life and Access to Innovation: Two Priorities in Medical Device Evaluations was organized by HAS on 24th of November to discuss evaluation principles of medical devices in France with manufacturers. In connection to the meeting new and updated policy documents were released.