Starting July 1st, 2017, ’When Class III and Implantable medical devices are put into service in France, the manufacturers or their authorized representative shall transmit to ANSM, the French Competent Authority a summary of their characteristics and particularly (in bold) the information which are not generally in the IFU:
1°: Identification of the medical device, the manufacturer and, where applicable, the authorized representative:
a) The name or commercial name of the medical device, its class of risk and the applicable classification rules;
b) The name, trade name or trademark of the manufacturer, the address of its head office and contact details; Where applicable, the same information concerning the authorized representative;
c) The date of preparation of the summary of characteristics and its version number;
2°: Elements on the use of the medical device:
a) The destination of the medical device including medical indications, contraindications and the target population;
b) The place of the medical device in the diagnostic or therapeutic strategy;
c) The users concerned and the training required for them;
d) Information on residual risks, any adverse reactions and any precautions for use;
3° A description of the medical device, including:
a) The operating principle of the medical device;
b) Where applicable, a reference to the previous model and a description of the modifications made;
c) A description of accessories, other medical devices or products or substances which are not medical devices, intended to be used in combination with the medical device;
d) A description or list of the various presentations or variants of the medical device that will be available;
4 ° Elements on clinical evaluation and follow-up after placing on the market:
a) A summary of the results of the clinical assessment
b) Information relating to the systematic review of data acquired on the medical device (PMS)
c) Any significant modification of an element mentioned above shall be notified without delay to ANSM
Warning: in the event of non-compliance with this requirement, the manufacturer or his authorized representative will be punished with a fine of € 150,000.
MediMark Europe understands by "putting into service" the stage at which a device has been made available to the final user as being ready for use on the Community market for the first time for its intended purpose. So it should concern only your new devices or variants of existing devices.
Written by René Clément on February 06, 2016
