ANSM (France) Clarifies CE Mark Exemption Process for Medical Devices

Sur January 27, 2025, le National Security Agency of Medicines and Health Products (ANSM) in France issued a key update regarding the process for obtaining CE mark exemptions for medical devices. This regulatory clarification outlines the specific conditions under which manufacturers can seek approval to market medical devices in France without CE certification, which is typically required to confirm compliance with EU safety and performance standards.

ANSM emphasizes that these exemptions are granted only under exceptional circumstances, primarily to safeguard public health and patient safety, in accordance with Article 59 of EU Regulation 2017/745.

CE mark derogations are strictly limited to situations where there is a compelling public health need or patient safety concern. To qualify, manufacturers must demonstrate significant patient benefit, supported by safety and performance data, and prove that no alternative products are available on the market.

There are two types of exemptions outlined in the update. Individual exemptions apply to specific patients based on urgent medical needs, while global exemptions cover broader cases but remain time-limited and scope-restricted. Healthcare professionals using devices under a derogation must inform patients about the lack of a CE mark, obtain their explicit consent, and report any incidents or risks associated with the device’s use.

ANSM will assess applications on a case-by-case basis, ensuring that exemptions remain exceptional and do not bypass standard regulatory pathways, including clinical investigations.

Manufacturers and healthcare providers involved in medical device supply or usage in France should carefully review ANSM’s updated guidance to ensure conformité et proper documentation when seeking a derogation.

For full details, refer to ANSM’s official publication on CE mark exemptions.