September 2026 recommendations about add-on reimbursement for medical devices in France

The French National Authority for Health (HAS) releases recommendations on the registration of medical devices and medical aids in the List of Reimbursable Products and Services (LPPR) based on assessments by the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS). 

The CNEDiMTS evaluation process begins with assessing the clinical (actual) benefit (Service Attendu, SA), which is classified as either sufficient or insufficient. Only devices with a sufficient clinical benefit are eligible for inclusion in the LPPR. If deemed sufficient, the clinical added value (Amélioration du Service Attendu, ASA) is then graded from I (major) to V (absent) for the claimed indications, influencing pricing decisions.

In September 2026, two favorable opinions were published on add-on reimbursement for two new medical devices in the cardiovascular and breast reconstruction fields.

An example is a transcatheter single-chamber implantable leadless ventricular pacemaker MICRA VR2 (application for registration; sufficient actual benefit; level V clinical added value compared to the MICRA VR).

Recommendations were also made regarding the registration of medical aids in the LPPR. The example of a favorable opinion includes a semi-closed loop system for the automated management of type 1 diabetes, mylife CamAPS FX, comprising mylife YpsoPump insulin pump, CamAPS FX app, and Dexcom G7 sensor (application for registration; sufficient actual benefit; level V clinical added value compared to other semi-closed loop systems listed on the LPPR).

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