France: New obligations on Class III and implantable medical device manufacturers

Manufacturers of Class III and implantable medical devices need to prepare for additional requirements on the French market. The new law, namely the French Decree 2016-1716, which was adopted on December 13, 2016, provides that manufacturers of those medical devices must communicate a summary of product characteristics to the French National Agency for the Safety of Medicines and Health Products (ANSM) when the medical device is put into service in France.  In addition to being applicable to manufacturers, the obligation also applies to their European authorized representative or distributors.

The new requirement will become applicable as of July 1, 2017.

For the new law (in french) please go to: Décret n° 2016-1716 du 13 décembre 2016 relatif au résumé des caractéristiques du dispositif médical.