Post-market surveillance and vigilance

Manufacturers are required to submit vigilance reports to the ANSM for any incidents occurred in France involving medical devices, in accordance with Regulation (EU) 2017/745.
The manufacturer must also take appropriate safety action when required.
Further information about reporting adverse incidents and corrective actions to ANSM is available for manufacturers of medical devices.
We encourage manufacturers to use European Medical Device Nomenclature (EMDN).

Manufacturer Incident Report (MIR)

Manufacturers should notify the ANSM of MIR using the MIR Manufacturer Incident Report (MIR) form.
Manufacturers should sent MIR (pdf and xml format) by mailbox: materiovigilance@ansm.sante.fr.
To monitor the registration of MIR, manufacturers have an access via Vigimater to put ANSM’s reference.

Access to Vigimater

Field Safety Corrective Actions (FSCAs)

Manufacturers should notify the ANSM of FSCA using the FSCA Report Form
Manufacturers should sent FSCA by mailbox: materiovigilance@ansm.sante.fr

Trend report

Manufacturers should notify the ANSM of trend report using the Manufacturer’s Trend Report Form.
Manufacturers should sent Trend Report by mailbox: materiovigilance@ansm.sante.fr.

Periodic Summary Report (PSR)

Manufacturers should notify the ANSM of Periodic Summary Report using the Manufacturer’s PSR Report Form.
Manufacturers should sent PSR by mailbox: materiovigilance@ansm.sante.fr.

Documents

Reporting

Device Specific Vigilance Guidance (DSVG)

The following guidances provide additional informations to manufacturers that can assist them to identify incidents and complaints associated with specific medical device on reporting adverse incidents for different types of medical device:

All guides can be consulted on the Europena Commission website

How to declare if you are a manufacturer or distributor of medical devices