Clinical evaluation of medical devices is no longer a mere regulatory formality.
It has become a strategic lever for accessing both the European market and the French market, where the expectations of the Haute Autorité de Santé (HAS) go far beyond CE marking requirements.
In short, CE marking grants access to the European market, but does not guarantee reimbursement in France.
To be prescribed, distributed, and funded, a medical device must demonstrate clinical added value—and that requires anticipation from the earliest design phase.
Clinical evaluation of medical devices for CE marking
CE marking for medical devices is mandated by Regulation (EU) 2017/745 (MDR).
It authorizes commercialization in the European Union once the device meets the General Safety and Performance Requirements (GSPR).
At this stage, clinical evaluation aims to demonstrate that:
- The device is safe for patients,
- It performs as intended,
- It provides a favorable benefit-risk ratio.
This demonstration relies on a Clinical Evaluation Report (CER), which includes data from one or more Clinical Investigations (CIR) as well as a critical review of published clinical data or prior clinical experience.
In other words, CE marking allows commercialization in the EU—but it does not yet establish the device’s medical value within a national healthcare system.
Reference: Regulation (EU) 2017/745 – MDR.
Clinical requirements by device class under the MDR
The MDR (Annex VIII) classifies devices by risk level, which determines the depth and rigor of the clinical evidence required:
| Class | Risk Level | Examples | Main Clinical Expectations |
| I | Low | Dressings, eyeglasses | Literature or clinical experience, no dedicated trials |
| IIa | Moderate | Contact lenses, non-invasive diagnostic devices | Performance and feasibility studies, strengthened documentation |
| IIb | High | Infusion pumps, orthopedic implants | Dedicated clinical trials, robust protocol, long-term follow-up |
| III | Critical | Cardiac implants, valves, pacemakers | Multicenter studies, advanced statistical design, long-term surveillance |
Reference: MDCG 2020-1 – Clinical Evaluation Guidance.
The ultimate goal remains the same: proving compliance with safety and performance requirements before placing the device on the market.
After CE marking: the French HAS evaluation
In France, actual market access requires an additional step: evaluation by the HAS, particularly the CNEDiMTS (National Commission for the Evaluation of Medical Devices and Health Technologies).
While CE marking focuses on regulatory conformity, the HAS assesses the medical and clinical value of the device within the French healthcare system, including:
- Clinical effectiveness compared to existing alternatives,
- Public health benefit,
- Real-world usability and performance,
- Demonstrated benefit for patients and healthcare professionals.
More information: HAS – Guide for medical device evaluation.
This step is essential for a device to be prescribed, distributed, and listed for reimbursement (LPPR).
Thus, a clinical evaluation sufficient for CE marking may still be deemed insufficient by the HAS if it fails to demonstrate a comparative clinical benefit over current medical practice.
Comparing expectations: Europe vs France
| Evaluation Level | Main Objective | Competent Authority | Type of Evidence Required |
| CE Marking (EU) | Verify safety and performance | Notified Body | Safety and performance data (MDR) |
| Market Access (France) | Assess clinical value and public health interest | HAS / CNEDiMTS | Comparative data, medical impact, quality of life, real-world evidence |
In short: CE marking grants the right to sell, but HAS approval determines the right to be used, prescribed, and reimbursed.
Case example: Somnio – a clinical validation setback
The therapeutic app Somnio, developed for insomnia management, illustrates this gap.
Despite successful clinical studies in Europe, the HAS ruled that the clinical evidence was insufficient to confirm its real-world efficacy.
The CNEDiMTS highlighted several weaknesses:
- Incomplete control of methodological biases,
- Limited comparability with existing treatments,
- Lack of robust long-term data.
Full review: HAS – Somnio (2024).
This example shows that a robust CE-compliant evaluation is not enough. Manufacturers must also anticipate national evidence expectations to ensure successful adoption.
Anticipating dual evaluation from the design phase
To succeed in France, manufacturers must think beyond CE marking from the start of development. This means:
- Integrating relevant clinical comparators into trials,
- Defining endpoints recognized by the HAS,
- Collecting real-world evidence (RWE) early in the market phase,
- Documenting the impact on quality of life and clinical practice.
By anticipating these dual expectations, manufacturers can streamline the transition from CE marking to HAS recognition and accelerate patient access to innovation.
Conclusion: clinical evaluation as the key to European and French success
Clinical evaluation of medical devices is the cornerstone of regulatory and market success.
It not only determines CE marking eligibility, but also clinical credibility and reimbursement potential in France.
France stands out for its methodological rigor—making it a demanding market, but also one that rewards quality.
By anticipating HAS expectations from the early design stage, manufacturers can turn regulatory compliance into a competitive advantage, ensuring both European conformity and national recognition.
Useful links
- Regulation (EU) 2017/745 – MDR
- MDCG 2020-1 – Clinical Evaluation Guidance
- HAS – Clinical evaluation of connected medical devices
- HAS – Somnio (2024)
- GMED – Clinical evaluation of medical devices
- See article: CE marking of medical devices: a critical clinical and regulatory milestone
- See article: CE marking and reimbursement: 2024 marks a turning point for clinical rigor in Europe
