Are you selling medical devices in France? Publication of Summary of the Characteristics of the Device for medical devices in France

From 1st July 2017, manufacturers, authorised representative and distributors of Class III and implantable devices (except custom-made devices) must communicate to ANSM a Summary of the Characteristic of the Device (SCD) when placing a device on the market in France. The SCD must be send by email to ANSM with the communication form for placing the device on the market.

This SCD must include:
1. Information for identification of the device and its manufacturer

  • Name, class and classification rules of the device
  • Name, address and contact details of the manufacturer and its authorised representative
  • Date and revision number of the SCD

 

2. Information for the use of the device

  • Intended use, intended population and contraindications
  • Position in the therapeutic or diagnostic strategy
  • Intended users, including any required training or education level
  • Undesirable effects, precaution for use and residual risks

 

3. Description of the device

  • Principle of operation
  • Reference to any previous model and relevant changes
  • Description of accessories, other medical devices and substances to be used with the device
  • List of all variant and configuration of the device

 

4. Information on Clinical Evaluation and post-market surveillance

  • Summary of the Clinical Evaluation
  • Procedure for collection and assessment of information on the device on the market

 

If non-compliant with this requirement, the manufacturer can be fined 150,000€.

The original decree has been published in the French Official Journal here.

Speak with one of our medical devices team if you are a Class III manufacturer selling in France and need help in complying with the new SCD requirements.