Declaring the unavailability of a medical device: creation of a European procedure

On January 10, 2025, the French National Agency for the Safety of Medicines and Health Products (ANSM) updated its procedures for medical device manufacturers to anticipate and manage unavailability. The new procedure harmonizes with European regulations, requiring manufacturers to submit advance declarations for certain situations of commercialization stoppage or temporary supply disruptions using a common EU form. This change aims to ensure continuity of care and patient safety through anticipation, information sharing, and transparency.