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 Elisabethann Wright of Hogan Lovells. Manufacturers are also must submit a summary of the device’s clinical evaluation and post-market surveillance plan.
Devices that are substantially modified are subject to the decree as well.
According to Wright, some of the required information previously was not communicated to ANSM unless the agency requested it. As a result, the decree represents an additional administrative burden for manufacturers and their authorized representatives, to which the mandate also applies.
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