Medical device market access in France does not end with CE marking. Once European conformity has been obtained under the MDR, manufacturers seeking coverage by French national health insurance still face a decisive step: evaluation by the National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS), part of the French National Authority for Health (HAS). Understanding this mechanism is essential for any project lead, particularly in the field of biomaterials and innovative devices, where medical device market access directly determines a product’s economic viability.
What Is Medical Device Market Access?
In France, medical device market access requires distinguishing between two notions that are often confused: the authorisation to sell, obtained through CE marking, and financial coverage, obtained through reimbursement by French health insurance. A device can be legally sold without being reimbursed. It is precisely this second step, reimbursement, that truly shapes medical device market access for manufacturers aiming for large-scale distribution in healthcare facilities or in community settings.
The CNEDiMTS’s Role in Medical Device Market Access
The CNEDiMTS is the body responsible for assessing the clinical value of medical devices before any reimbursement decision. The manufacturer submits an evaluation file including available clinical data, relevant comparators and expected patient benefits. This evaluation shapes the entire medical device market access pathway, since an unfavourable opinion from the committee effectively closes the door to reimbursement by French national health insurance.
LPPR Listing, a Decisive Step in Medical Device Market Access
Once the CNEDiMTS has issued its opinion, listing on the List of Reimbursable Products and Services (LPPR) opens the way to community-setting coverage, while other devices fall under the supplementary list or intra-DRG hospital funding. This choice of funding pathway is an integral part of the medical device market access strategy and must be anticipated from the earliest definition of the product’s commercial strategy. The HAS guide on evaluation principles details these pathways precisely, along with the documents expected in the file.
ASA and Expected Benefit: The Criteria That Shape Medical Device Market Access
The CNEDiMTS bases its decision on two complementary notions: expected benefit (SA), which determines whether the device is likely to be listed, and improvement in expected benefit (ASA), which determines the level of coverage and directly influences the price negotiated with the Economic Committee for Health Products (CEPS). The higher the ASA obtained, the more favourable medical device market access becomes, which encourages manufacturers to build a comparative, rather than purely descriptive, clinical evidence plan very early on.
Anticipating Reimbursement from the Clinical Design Stage
For manufacturers of innovative devices, particularly in the field of biomaterials, the challenge is not to wait for CE marking before thinking about reimbursement. Early discussions with HAS, the selection of relevant comparators, and the design of a clinical protocol aligned with the CNEDiMTS’s expectations all help secure the entire regulatory pathway well in advance. This foresight avoids costly back-and-forth and turns an administrative constraint into a competitive advantage over less-prepared competitors.
A Pathway to Master for Successful Market Access
Medical device market access in France therefore rests on a precise mechanism, in which CE marking is only a first step. CNEDiMTS, LPPR, ASA: each of these milestones determines a device’s ability to find its economic model in France. For manufacturers, the challenge is to surround themselves, from the clinical design stage onward, with regulatory and scientific expertise capable of anticipating these requirements rather than being caught off guard by them.
BluePharm supports medical device manufacturers in producing up-to-date scientific and regulatory content, to help them understand and anticipate the key steps of market access.
