Medical Device Regulatory Framework in France
Medical devices placed on the French market are primarily regulated under the EU medical device framework, supplemented by national French legislation and requirements.
Regulation (EU) 2017/745 (MDR)
The main European regulatory framework for medical devices, covering market access, conformity assessment, safety and performance, post-market surveillance and vigilance.
Regulation (EU) 2017/746 (IVDR)
The European regulatory framework applicable specifically to in vitro diagnostic medical devices.
French Public Health Code (Code de la santé publique)
Supplements EU legislation with national provisions governing medical devices in France.
French National Agency for the Safety of Medicines and Health Products (Agence nationale de sécurité du médicament et des produits de santé, ANSM)
The French competent authority responsible for market surveillance, vigilance, clinical investigations and regulatory oversight of medical devices.
CE Marking
CE marking (European Conformity) is required before a medical device can be placed on the market, subject to the applicable conformity assessment procedure and device classification. It indicates that the manufacturer declares that the device complies with the applicable EU regulatory requirements and can be placed on the market in the European Economic Area.
Harmonised and technical standards
It includes ISO 13485 for quality management systems, ISO 14971 for risk management, IEC 62366-1 for usability engineering and, where applicable, IEC 62304 for medical device software.
French language requirements
Information supplied with devices intended for users or patients in France must comply with applicable EU and national language requirements.
General Data Protection Regulation (GDPR)
The GRPR applies where medical devices involve the processing of personal data, including health data.
Clinical investigation requirements
Governed primarily by the MDR and supplemented in France by the Public Health Code and ANSM/ethics committee procedures.
Post-market surveillance and materiovigilance
EU PMS and vigilance requirements are supplemented by the French materiovigilance system overseen by ANSM.
Contact Emi Lecret for specialist support with:
- French localisation
- Medical device translation
- UX writing for MedTech
- French Expert Reviews and Audits for MedTech & HealthTech User Interfaces
Emi Lecret
– Medical writer | Translator | Localization specialist | Communication strategist for MedTech companies
Share
