Overview

With a steady growth of innovative medical procedures, every day, the 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 Medical Devices import and marketing in the country.

Prior to marketing the Medical Devices, either Active Implantable Medical Devices (IMAD) 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.

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

Freyr has dedicated expertise for supporting device manufacturers in obtaining CE marking. Our 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.

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 with ANSM
  • Registration of Foreign Medical Device Manufacturers in France
  • ISO 14971 Risk Management Consulting
  • Medical Device Regulatory Strategy Report
  • Testing Support- Biocompatibility, Electrical Safety and Mechanical & Performance
  • Labeling and GMP Support
  • Post-market Monitoring and Adverse Event Reporting
  • European Authorized Representative Support

 

Freyr Advantages

  • Successful submissions for varied class of devices
  • Access to local affiliates
  • Dedicated personnel to provide Medical Device and IVD Regulatory support
  • In-country or legal representative support with a cost-effective model