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April 2, 2025
Approximately 5 minutes
ANSM's Mission: Monitoring the Medical Device Lifecycle and Market Surveillance in France
ANSM's Mission: Ensuring Medical Device Safety in France
The Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), as the French national competent authority, is primarily mandated to ensure that the benefit-risk balance for all health products, including medical devices (MDs) and in vitro diagnostic devices (IVDs), remains positive throughout their entire lifecycle.
1. Market Surveillance and Vigilance
ANSM’s evaluation and market control activities are central to patient safety. This surveillance encompasses two key areas:
- Vigilance System: The centralisation and assessment of incident reports. This system is known as Medical Device Vigilance for MDs and Reactovigilance for IVDs. Reports come from healthcare professionals, patients, and users.
- Proactive Control: ANSM’s monitoring is not limited to reported incidents. It actively conducts conformity checks through manufacturers’ market launch notices, clinical trial/advertising applications, and laboratory controls. The evaluation can include reviewing the manufacturer's technical documentation and clinical data.
2. Market Listing and Identification
To support effective market surveillance, ANSM requires mandatory notification:
- French Manufacturers: Manufacturers of Class I devices and custom-made devices based in France must submit a compulsory declaration of their activity.
- Other Market Players: Manufacturers, agents, and distributors of other classes must also notify the ANSM prior to market release in France, which helps identify devices and market players operating in the country.
3. Quality and Advertising Control
ANSM also regulates specific aspects of device deployment:
- Quality Control: ANSM defines quality control standards for medical devices, initially focusing on devices emitting ionising radiation. It relies on accredited independent bodies to verify on-site compliance with these standards.
- Advertising Control: Advertising for certain MDs/IVDs that pose a significant health risk requires prior approval from ANSM, which is granted for 5 years, subject to CE marking certificate validity. Retrospective control applies to other advertising.
4. Enforcement and Sanctions
In the event of non-compliance, ANSM possesses significant enforcement authority, including the power to:
- Order the manufacturer to take corrective measures.
- Notify Notified Bodies and other competent authorities across Europe.
- Take measures suspending or banning devices from the French market.
- Implement a system of financial sanctions.
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