A recently implemented decree by France’s Agency for the Safety of Health Products (ANSM) requires manufactures of Class III and implantable medical devices to provide new summaries of product characteristics when a device is put into service.

Summaries must include basic product characteristics such as the device’s name and classification, purpose, targeted users, principles of operation, accessories, and version descriptions, according to Elisabeth Ann Wright of Hogan Lovells. In addition, manufacturers must submit a summary of the device’s clinical evaluation and post-market surveillance plan.

Devices that are substantially modified are also subject to the decree.