The clinical development of digital medical devices—and especially digital medical devices (DMDs)—must follow a strict methodology to guarantee safety, performance, and added value. In 2021, the Haute Autorité de Santé (HAS) published a Methodological Guide for the clinical development of medical devices, which has become an essential reference for industry stakeholders.
This article highlights the main principles of the guide and explores their implications for the evaluation of digital medical devices, focusing on the type of clinical evidence required for reimbursement.
Why a specific guide for the clinical development of digital medical devices?
Unlike drugs, medical devices are extremely diverse: from health software and connected sensors to implants and monitoring platforms. Their clinical evidence must therefore be adapted to the nature of each device and its intended use.
The HAS guide provides a unified methodological framework, grounded in evidence-based medicine (EBM), to evaluate:
- Safety,
- Technical performance,
- Expected clinical benefit,
- Organizational impact on the healthcare pathway.
Principles of clinical evaluation for medical devices
1. Demonstrating safety and performance
Every device must first prove regulatory compliance (CE marking) and demonstrate that it works as intended. This includes materiovigilance data, technical tests, and preclinical studies.
2. Defining relevant endpoints
HAS emphasizes the importance of selecting clinical outcomes directly related to the device’s purpose, such as:
- Survival, reduction of complications, functional improvement,
- Quality of life (especially through PROs – patient-reported outcomes),
- Health-economic and organizational impact.
3. Prioritizing comparative trials
Randomized controlled trials (RCTs) remain the gold standard, but alternative methodologies may be accepted when randomization is not feasible. In these cases, manufacturers must justify their choices and properly document potential biases.
4. Leveraging real-world data
Observational studies and registries provide complementary evidence, assessing device performance in non-experimental, real-world settings.
Focus: specificities for digital medical devices
For digital medical devices (DMDs), HAS underlines additional requirements:
- Interoperability and cybersecurity: technical compliance is a prerequisite.
- PROs and patient experience: DMDs must demonstrate value through outcomes reported directly by patients, such as adherence, comfort, or quality of life.
- Organizational impact: while many DMDs claim to streamline care pathways, these benefits must be quantified rather than described qualitatively.
Example: a telemonitoring software solution claiming to reduce hospitalizations must provide data demonstrating measurable reductions in emergency admissions or improvements in medical coordination.
Common mistakes in clinical dossiers
The HAS guide highlights frequent pitfalls that often undermine DMD applications:
- Poorly chosen or irrelevant comparators,
- Clinical studies conducted on earlier device versions not applicable to the evaluated version,
- Reliance on technical performance data without demonstrating clinical benefit,
- Organizational indicators described qualitatively, without numerical measurement.
These shortcomings frequently lead to reimbursement refusals.
The strength of a clinical development plan directly determines the chances of success for:
Implications for reimbursement
- LATM listing for telemonitoring activities,
- LPPR listing for therapeutic digital devices,
- Or PECAN fast-track for early reimbursement access.
Without robust, targeted clinical evidence, the risk of rejection is high.
BluePharm: transforming methodology into reimbursement strategy
Building a dossier that meets HAS expectations requires both methodological and regulatory expertise. BluePharm supports manufacturers at every stage by providing:
- Definition of the most relevant comparator,
- Design of robust clinical studies,
- Rigorous documentation of organizational impact,
- Integration of medico-economic and real-world data.
By applying the HAS methodological guide, BluePharm helps companies secure their clinical development and maximize reimbursement opportunities.
Conclusion: from methodology to market access
The HAS clinical development guide is now a cornerstone for digital medical device evaluation in France. It establishes clear expectations for safety, performance, and clinical benefit, while integrating organizational and patient-centered outcomes.
For innovators, this means aligning early with HAS requirements, avoiding common pitfalls, and documenting measurable impacts. With the right methodological and regulatory support, DMD manufacturers can transform compliance into a strategic advantage, paving the way for sustainable reimbursement and faster patient access to innovation.
Useful links
- HAS Methodological Guide (2021) – download the document
- HAS – Clinical evaluation of digital medical devices (LATM, 2025) – read here
- HAS – PECAN fast-track (2025) – consult the document
- HAS – Mapping organizational impacts (2020) – read the document
- Article – Clinical evaluation of digital medical devices and LATM: regulatory and clinical requirements
- Article – PECAN fast-track pathway: evaluating digital medical devices
