Medical Devices Regulatory Services
in France

Overview

With a steady growth of innovative medical procedures, Medical Devices market in France offers a good bet of opportunities for foreign manufacturers. The National Agency for the Safety of Medicines and Health Product – France (ANSM) is the competent authority responsible for regulating import and market-entry of Medical Devices in the country.

Regulatory Authority: The National Agency for the Safety of Medicines and Health Product (ANSM)

Regulation: Medical Device Regulations, 2017

Regulatory Pathway: CE marking followed by Notification

Authorized Representative: European Authorized Representative (EAR) for Non-EU manufacturers

QMS Requirement: ISO 13485:2016

Assessment of Technical Data:  Notified Body for CE marking

Validity of License: Unlimited

Submission Format: Paper

Language: French

France Medical Device Classification

Prior to marketing the Medical Devices, either Active Implantable Medical Devices (AIMD) or In-vitro Diagnostic Medical Devices (IVDDM), it is mandatory for the manufacturers to obtain CE certification. In order to affix the CE marking, the market entrant must submit the devices to compliance evaluation with the essential requirements described in the applicable European directives. These European provisions have been transposed into French law in the Public Health Code.

European Authorized Representative (EAR) Services

Manufacturers based out of the European Union shall appoint a European Authorized Representative (EAR) to market the devices in any EU member country. The EAR, thus appointed, shall comply with all requirements defined in Medical Device Regulations (EU)2017/745.

France Medical Device Registration

All Class I Medical Devices are required to be registered with the ANSM and Class IIa, IIb and III devices must proceed for marketing after the notification. There is no online procedure in France; registration and notification are done by filing the relevant application forms and submitting the documents to the ANSM.

Process flow

Post Approval Device Life Cycle Management

Freyr supports foreign manufacturers in end-to-end Medical Device lifecycle management, including post approval activities, such as:

  • Post approval change management - modifications to existing Medical Device approvals such as, addition of new variants, accessories; addition of new indications of use among others
  • Maintenance of ISO 13485:2016 and CE certification
  • Renewal of licenses
  • Liaising between Notified body and the manufacturer

Freyr has dedicated expertise for supporting the device manufacturers in obtaining CE marking. Freyr’s experts assist in device classification, product notification/registration, technical file preparation, etc. in compliance with the EU and ANSM regulations for successful device approval and market-entry.

Summary

Type of Device

Risk

QMS Audit

CE Marking

Regulatory Pathway

Class I

Low Risk

N/A

CE Self-Certification

Registration

Class IIa

Low- Moderate Risk

ISO 13485:2016 certification

CE Mark

Notification

Class IIb

Moderate - High Risk

ISO 13485:2016 certification

CE Mark

Notification

Class III

High risk

ISO 13485:2016 certification

CE Mark

Notification

Expertise

Freyr Expertise

  • European Medical Device Classification
  • ISO 13485 Compliance
  • CE technical file or design dossier review, compilation and submission
  • EU-MDR Transition and support
  • Clinical Evaluation Reports (CER) for Medical Devices
  • Notification/Registration of Medical Devices through Notis Online Registration System
  • ISO 14971 Risk Management consultation
  • Medical Device Regulatory strategy report
  • Testing support- biocompatibility, electrical safety, mechanical and performance
  • Labeling and GMP support
  • Post-market monitoring and Adverse Event reporting
  • European Authorized Representative support