FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

France Simplifies Regulations for Implantable and Class III Devices

June 11, 2018
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France’s National Authority on Drugs and Health Products (ANSM) simplified regulations for registering implantable and Class III devices following a ruling by the French Supreme Court that overturned a December 2016 decree requiring device manufacturers or their representatives to submit a summary of characteristics to the authority.

The Conseil D’Etat ruled the state should not impose separate requirements relating to placing medical devices on the market in addition to the EU’s CE marking requirements. 

The ruling came in response to a challenge by SNITEM, the French medical device syndicate, which argued successfully that the industry should comply with the summary of safety and clinical performance required under the EU’s 2017 Medical Device Regulation.

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