The market is full of promising connected medical devices and digital therapeutics. Yet the limits of medical device reimbursement in France let only a handful of them through. For therapeutic digital medical devices, the CNEDiMTS (the French National Committee for the Evaluation of Medical Devices and Health Technologies) has issued only one favourable opinion since the assessment pathway was created: Joe, Ludocare’s solution for childhood asthma, in April 2026. It is a striking figure, and it raises three questions: why are these limits so hard to overcome, which solutions have managed it, and do other countries do better?
The limits of reimbursement for digital medical devices (digital therapeutics) in France
The early access to reimbursement scheme (PECAN), created to give therapeutic digital medical devices early access to reimbursement, has produced only one favourable opinion in several years of existence. On the remote monitoring side, only one solution, Cureety Techcare, currently benefits from permanent reimbursement through the dedicated generic line. For a sector that keeps raising funds and filing applications, this success rate is a concrete illustration of the limits of medical device reimbursement in France, and goes far beyond a simple administrative delay.
Why do innovative medical devices struggle to overcome these reimbursement limits?
Several factors explain the limits of medical device reimbursement. First, PECAN funding is only transitional: twelve non-renewable months, during which the manufacturer must generate real-world data robust enough to convince the CNEDiMTS to grant permanent reimbursement. Second, budget pressure weighs on the entire system, not just on digital health: four decrees published at the end of August 2026 will reduce, from January 2027, the reimbursement rate of medical devices listed on the LPPR (the French list of reimbursable products and services), from 50–60% to 40–50% for most items. The government justifies this cut by the need to “fund the most innovative and costly treatments and medical devices”. In other words, public money is being squeezed on existing products to free up room for innovation, which increases the pressure on every application submitted.
Cureety Techcare and Joe: the rare exceptions, and what they did differently
These two cases took different routes. Cureety Techcare relied on medical remote monitoring, an older and already stable funding pathway with a generic remuneration line set out in law. Ludocare, by contrast, had to build a complete comparative clinical dossier for Joe: a demonstrated, measurable reduction in asthma exacerbations in children compared with standard care, exactly the level of evidence the CNEDiMTS expects. What the two have in common: neither treated reimbursement as a formality to be settled after market launch.
Are these limits of medical device reimbursement unique to France?
In Germany, the DiGA scheme shows a very different track record: 55 digital health applications listed since 2019, only 6 withdrawn, more than 300,000 prescriptions issued and around €80 million reimbursed in 2024, a market that has grown sevenfold since 2021. The difference lies less in scientific rigour, which is comparable on both sides of the Rhine, than in the design of the system: in Germany, a 12-month provisional assessment phase leads to permanent listing in the catalogue if the evidence is there, whereas in France PECAN remains a non-renewable gateway, reassessed case by case. The result is mechanical: more solutions make the cut in Germany, while the limits of medical device reimbursement in France keep the door narrow.
Anticipating the limits of medical device reimbursement from the product strategy stage
For manufacturers, the lesson from these two cases and this European comparison is clear: do not wait until the PECAN application to think about reimbursement. Explore established pathways early (remote monitoring, the standard LPPR route for physical devices), build a comparative rather than descriptive evidence plan, and keep a close eye on budget developments, as France tightens reimbursement rates from 2027. The limits of medical device reimbursement are not set in stone, but they require much earlier preparation than many manufacturers expect.
BluePharm supports manufacturers of medical devices and digital health solutions in building their regulatory and scientific strategy, turning these reimbursement constraints into a well-managed path to market.
Read also:
- Reimbursement of a digital therapeutic: HAS opens a historic first
- CE marking and reimbursement: a turning point for clinical rigour in Europe
To train your teams on these issues, see our training course on digital medical devices: regulation and reimbursement (module 17, in French).
