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France: ANSM Designates AFNOR as the Newest Notified Body

Medical devices to be marketed in the European market must obtain CE Marking as proof the devices meet the highest safety, health, and environmental requirements.

Officially from 23 April 2024, The French National Agency for the Safety of Medicines and Health Products (ANSM) appointed AFNOR Certification as France’s Notified Body, authorized to evaluate medical devices and issue CE markings for the validated manufacturers. The body type and number is NB 0333.

Furthermore, Regulation 2017/745 also has tightened its requirements for Notified Bodies to ensure they can demonstrate competence and impartiality. There are new obligations for Notified Bodies practice: unannounced manufacturer’s inspections, reinforced clinical evaluation, and reinforced surveillance for post-marketing.

This designation shows that France is committed to providing the highest quality of its public health and ensuring the production of medical devices can maintain and comply with global standard regulations. This action could facilitate smoother market transactions and provide a stable supply, thereby preventing disruption in healthcare treatments.

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