Market Access Strategy for Medical Devices in Europe
Strategic recommendations on the topic of market access pathways for medical devices and IVD tests
White Paper: Evidence requirements for LPPR List process in France, part 1
Get insights from MTRC White Papers to enhance your understanding of the analysis of five HTAs and strategic recommendations for evidence generation strategy in France
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February 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 February 2026, six favourable opinions were issued concerning add-on reimbursement for new medical devices in cardiovascular, peripheral vascular, and ENT fields. Some examples are provided below:
- AVEIR retrieval catheter for transcatheter implantable leadless pacemakers from Abbott (application for registration; sufficient actual benefit; level V clinical added value compared with the pacemaker left in place and deactivated);
- Bioprotec +2/+8°C arterial allograft from Bioprotec (application for registration; sufficient actual benefit; level V clinical added value compared to cryopreserved arterial allografts).
Favourable opinions were also issued regarding the extension of indications for two devices: Abbott transcatheter ventricular leadless pacemaker AVEIR VR and Edwards PASCAL Precision transcatheter mitral valve repair system.
See the details in French here.
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