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July 1st 2017: New Notification Rules in France for Class 3 and 2b implantable Medical Devices

Modalities for the transmission of the Summary of the Characteristics of the Device Medical to ANSM

Starting July 1st 2017, additional information (mainly on clinical evaluation and PMS) is required by ANSM, the French national competent authority, in addition to the current notification for any new devices class 3 and class 2b implantables put on the market after June 30, 2017.

You will find attached a MediMark Free English translation of the requirements.Since no form is available at this date from ANSM, MediMark Europe has created a bilingual form which should be filled in French for your new devices.

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