The PECAN pathway (PECAN – Prise en Charge Anticipée Numérique) stands out from the traditional reimbursement routes (LATM or LPPR) by its speed and specific eligibility conditions.
A limited duration: 12 months maximum, non-renewable.
Two cumulative eligibility criteria: CE marking in the claimed indication and a presumption of clinical or organizational innovation.
Mandatory ongoing studies: these must be able to provide, within 6 to 9 months, sufficient data to transition toward standard reimbursement routes.
In practice, PECAN works as a fast-track system. It allows rapid diffusion of digital medical device (DMD) innovations, but requires manufacturers to carefully anticipate their clinical and organizational strategy.
PECAN : clinical and organizational eligibility criteria
1. CE marking in the claimed indication
Without a valid CE marking in the relevant indication, the application is automatically rejected.
2. Presumption of innovation
The DMD must demonstrate, based on preliminary data:
- A potential clinical benefit: improved quality of life, fewer hospitalizations, better treatment adherence, reduced complications, etc.
- And/or an organizational benefit: more efficient follow-up, better multidisciplinary coordination, easier access to care without compromising quality.
Example: a digital oncology remote monitoring solution received a favorable PECAN opinion thanks to PROs (Patient-Reported Outcomes) showing improved quality of life and fewer unplanned hospitalizations, supported by ongoing studies on patient and physician satisfaction.
The central role of ongoing studies
The CNEDiMTS attaches great importance to studies already underway at the time of submission. These must:
- Match the indication claimed,
- Include the appropriate target population,
- Define relevant endpoints (clinical or organizational),
- Follow a timeline that allows results to be delivered within the legal deadlines (6 months for LPPR, 9 months for LATM).
Example: a PECAN request for pediatric asthma remote monitoring was rejected because the studies did not include the most severe patients, and the timeline did not allow results within the required timeframe.
Common reasons for rejection
The HAS guidelines highlight several pitfalls leading to negative PECAN decisions:
- Available data only technical, with no proof of clinical impact.
- Studies failing to isolate the DMD’s effect from that of a drug treatment.
- Claimed indication not aligned with the populations studied.
- Ongoing studies not yet started or lacking detailed protocols.
Example: a digital monitoring tool for chemotherapy-related fever was rejected because existing studies were non-specific and ongoing protocols could not guarantee relevant results within nine months.
Building a strong PECAN application
A successful PECAN file must:
- Clearly define the indication and target population,
- Rigorously document clinical or organizational innovation,
- Provide detailed and coherent ongoing study protocols,
- Anticipate the transition toward LPPR or LATM.
Positive example: a digital rehabilitation device obtained PECAN thanks to favorable preliminary data and a robust ongoing study demonstrating improvement in patients’ functional capacity with rigorous follow-up.
PECAN: a major opportunity for digital medical devices
The PECAN pathway offers unprecedented opportunities for digital medical devices in France. It enables faster market access but demands:
- Anticipation of clinical evidence,
- Strong documentation of organizational impact,
- Alignment with CNEDiMTS methodological expectations.
For manufacturers, PECAN is both a chance and a challenge: a chance to speed up reimbursement, but a challenge because the fast-track is conditional on delivering timely, relevant evidence.
BluePharm: your strategic partner for PECAN success
At BluePharm, we support companies in making PECAN a success by:
- Structuring PECAN application files,
- Securing protocols of ongoing studies,
- Integrating clinical, organizational, and health-economic components,
- Preparing the transition toward LATM or LPPR.
In short, BluePharm is a strategic partner to transform PECAN opportunities into sustainable reimbursement success.
Conclusion: PECAN as a fast-track for digital health innovation
The PECAN pathway represents a turning point for digital medical devices in France. By enabling rapid access while ensuring robust evaluation, it creates a balance between innovation speed and regulatory rigor.
For companies, mastering PECAN requires foresight, clinical preparation, and the ability to document organizational benefits. With the right expertise, PECAN can accelerate market access and pave the way for lasting inclusion in standard reimbursement frameworks.
Useful links
- HAS Guide – PECAN (2025): download the official document
- PECAN submission guide (2023): reach the guide
- HAS – Mapping organizational impacts (2020) : read the book
- Methodological guide for the clinical development of medical devices (2021) : consult the guide
- Guide on the clinical evaluation of connected medical devices (2019) : download
- Article Clinical evaluation of digital medical devices and LATM: regulatory and clinical requirements see article
