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
White Paper: Evidence requirements for LPPR List process in France, part 2
Get insights from MTRC White Papers to discover five recent HAS reports with negative recommendations (March 2024)
Recent news and posts
March 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 March 2026, three favorable opinions were issued on add-on reimbursement for new medical devices in the fields of gastrointestinal endoscopy, men’s health, and orthopedics. Some examples are provided below:
- A single-use SpyBite Max Biopsy Forceps (Boston Scientific) for tissue acquisition in the pancreaticobiliary system by Boston Scientific (application for registration; sufficient actual benefit; level V clinical added value compared to SpyBite);
- Plasmafit Dual Mobility, a dual mobility acetabular cup consisting of a cementless cup, a metal alloy insert, and a highly cross-linked polyethylene insert enriched with vitamin E by B. Braun Medical (application for registration; sufficient actual benefit; level V clinical added value compared to single-mobility acetabular cups with a conventional polyethylene insert).
See the details in French here.
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