When MedTech companies discuss real-world evidence (RWE), the conversation often focuses on collecting additional clinical data. In reality, real-world evidence in France supports reimbursement strategy, hospital adoption, physician engagement and go-to-market execution.
First, an essential regulatory reminder: for medical devices, real-world data (RWD) is not optional. The European Medical Devices Regulation (EU 2017/745) places real-world evidence at the core of continuous clinical evaluation through post-market clinical follow-up (PMCF), post-market surveillance and continuous benefit-risk assessment.
Source = European Commission – Medical Devices Regulation (EU) 2017/745
https://health.ec.europa.eu/medical-devices-sector_en
The French Haute Autorité de Santé (HAS) recognises specificities of MedTech evaluation including:
- patient selection,
- reproducibility of outcomes,
- operator dependency,
- learning curves,
- organisational impact,
- long-term performance,
- the practical difficulties of conducting randomized controlled trials.
For reimbursement dossiers, registries often help answer a key HAS question: ‘Will this technology deliver value in routine clinical practice within the French healthcare system?’
HAS generally considers registries alone insufficiently robust to support a positive HTA decision. Whenever feasible, randomized controlled trials remain the gold standard.
Source : HAS guidelines for RWE generation
https://www.has-sante.fr/jcms/fc_2875170/fr/dispositifs-medicaux
A valuable registry requires clear objectives, clinically relevant endpoints, rigorous governance, quality monitoring, meaningful follow-up, credible investigators and registration on ClinicalTrials.gov. Results should ideally be documented through a clinical study report or peer-reviewed publication.
Another critical point often underestimated: registries are also a go-to-market tool. They help engage KOLs early, structure reference centres, support training and adoption, identify responder profiles and progressively build a community of users.
Common Mistake
Many companies wait for reimbursement or commercial traction before launching structured real-world evidence generation. Early registry data can refine positioning, support discussions with HAS and CEPS, strengthen KOL engagement and prepare the future reimbursement narrative.
My Best Advice from French Real Life
- Implement an official registry before the first clinical use of the first device.
- Seek endorsement from an academic group whenever possible. An academically supported registry has a stronger impact for both reimbursement and go-to-market.
Strategic Takeaway
The question is not ‘Do we need a registry?’ but ‘Are we generating the type of real-world evidence that will support both reimbursement and adoption in France?’ Real-world evidence is about proving relevance in daily clinical practice.
