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.