Decree No. 2016-1716, which sets out the information to be submitted to the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) when notifying Class III and implantable Medical Devices, became effective in France.
As of July 1, 2017, manufacturers intending to market their devices in France shall submit a dossier to the Regulatory Authority including, inter alia, the device instructions for use, a summary of the data subject to clinical evaluation and information relating to post-market clinical follow-up.
The documentation must be submitted in French to the ASNM prior to the device first placing on the market in the country.
For more information:
https://www.legifrance.gouv.fr/eli/decret/2016/12/13/AFSP1631048D/jo/texte
