The year 2024 has represented a major milestone for CE marking and reimbursement of medical devices. The full transition to Regulation (EU) 2017/745 (MDR) has reinforced the clinical rigor of CE marking, while France’s Haute Autorité de Santé (HAS) has raised the bar for national reimbursement.
Between regulatory compliance and clinical evaluation, the gap is narrowing — and manufacturers must now plan for both levels simultaneously.
CE marking and reimbursement: fewer certified devices, but stronger clinical evidence
According to data from TEAM-NB, the European association of notified bodies, 11,292 MDR certificates had been issued by the end of 2024 — a steady increase since 2022. By February 2025, the 14th Notified Bodies Survey by the European Commission confirmed 12,177 cumulative MDR certificates across all risk classes (European Commission, 2025).
While these figures do not specify how many applications included prospective clinical trials, they clearly reflect the rise in clinical expectations. Conformity assessments now systematically include a Clinical Evaluation Report (CER) compliant with Annex XIV of the MDR.
Notified bodies have prioritized Class IIb and III devices, particularly in cardiology, orthopedics, and digital health. According to the MedTech Europe 2024 report, most manufacturers consider the clinical data burden “significantly increased”, a direct outcome of Europe’s new evidence-based regulatory approach.
France: the dual requirement of CE marking and reimbursement
Obtaining CE marking is no longer enough. To be prescribed and reimbursed, a device must convince the HAS of its clinical and organizational value.
The CNEDiMTS, the national committee responsible for evaluating medical devices and health technologies, assesses:
- Clinical benefit compared with existing medical practice,
- Public health value,
- Organizational and health-economic impact.
In 2024, the HAS reviewed several innovative devices, including an increasing number of digital medical devices (DMDs) covered under LATM (telemonitoring activities) or temporary reimbursement schemes (Article L.165-1-1 of the Social Security Code).
2024 pilot cases: testing the new reimbursement framework
Endotest® (Ziwig) – Saliva-based diagnostic for endometriosis
HAS Opinion No. 2024.0066/AC/SEAP (October 17, 2024) – Temporary reimbursement granted under Article L.165-1-1 of the French Social Security Code.
Clinical data: diagnostic performance for a disease prevalence of 49%
- Sensitivity: 0.95 [0.89 – 0.98]
- Specificity: 0.94 [0.88 – 0.98]
- Negative predictive value: 0.95 [0.91 – 0.99]
- Negative likelihood ratio: 0.05
Endotest® marks the first saliva-based diagnostic test to receive temporary public funding in France.
SonoCloud-9 (Carthera) – Neuro-oncology
HAS Opinions No. 2024.0003/AC/SED (March 7, 2024) and 2024.0027/AC/SED (April 25, 2024) – Positive opinions for the implantable ultrasound device that facilitates chemotherapy for glioblastoma.
Phase I/II studies demonstrated tolerance and preliminary efficacy for transient opening of the blood–brain barrier.
These cases illustrate a methodological shift: the HAS now accepts progressive evidence generation, provided that clinical protocols are clear and data collection is time-bound and supervised.
LATM 2024: telemonitoring under scientific scrutiny
The List of Medical Telemonitoring Activities (LATM) has become the standard reimbursement pathway for digital medical devices.
The 2024 CNEDiMTS annual report cites seven opinions for LATM-listed DMDs involving associated medical services.
Evaluation criteria included:
- Comparison with conventional care or already listed telemonitoring activities,
- Real-world evidence (RWE) to confirm effectiveness and adherence,
- Quantified organizational impact, such as fewer hospitalizations and improved care coordination.
The HAS now demands quantified outcomes and systematically rejects descriptive or non-comparative submissions.
CE marking vs HAS evaluation: complementary frameworks
| Evaluation Level | Main Objective | Authority | Type of Evidence Required |
| CE Marking (EU) | Verify safety and performance | Notified Body | Safety and performance data (MDR Annex XIV) |
| Reimbursement (France) | Demonstrate clinical value and public health interest | HAS / CNEDiMTS | Comparative data, medical impact, RWE, quality of life metrics |
CE marking opens the European market, while HAS evaluation determines actual usage and funding in France.
The most successful manufacturers are those who anticipate both requirements from the design stage onward.
2025 trends: transparency and convergence on the horizon
- EUDAMED, the public European database for medical devices, is expected to become fully operational in 2025.
- The France–Germany 2025 Agreement aims to align the PECAN (France) and DiGA (Germany) frameworks, paving the way for joint European evaluations.
- The HAS will publish a new guide on real-world studies for medical and digital devices.
These developments confirm a clear trend: greater alignment between European and national standards for clinical evidence and real-world value demonstration.
What this means for manufacturers
Companies must now treat regulatory and clinical strategy as a continuous process:
- Plan clinical evidence to meet both MDR and HAS expectations,
- Integrate relevant comparators and patient-centered outcomes (PROs),
- Prepare the reimbursement dossier as early as CE certification,
- Document organizational and economic impact, now a decisive success factor in France.
Conclusion: 2024, the year of clinical maturity
The year 2024 confirmed a qualitative leap in Europe’s medical device framework.
The 11,292 MDR certificates recorded illustrate rising clinical rigor, while Endotest® and SonoCloud-9 highlight how France is combining innovation with scientific discipline.
The French market remains one of the most demanding yet influential in Europe — setting high standards that now shape the future of evidence-based medical innovation.
References
- TEAM-NB, Medical Device Survey 2024 (11,292 MDR certificates)
- European Commission, 14th Notified Bodies Survey (Feb. 2025 – 12,177 certificates)
- MedTech Europe, IVDR & MDR Survey Report 2024
- HAS, Opinion No. 2024.0066/AC/SEAP (Endotest®)
- HAS, Opinions No. 2024.0003/AC/SED and 2024.0027/AC/SED (SonoCloud-9)
- CNEDiMTS, 2024 Activity Report (7 LATM evaluations)
- Santé.fr – Endotest technical sheet (2024)
- See article: Clinical evaluation of medical devices: anticipating CE marking and market access in France
- See article : A new CE marking for medical devices: towards a simpler, more predictable system
