Medical device players
Identify the key players involved in medical devices
For your market entry challenges
Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM)
The ANSM is in charge of monitoring the market for health products, including medical devices (MDs)
As the competent authority, it is responsible for assessing, designating and monitoring Notified Bodies (NBs) in France
The Notified Bodies issue the EC certificate
- Several NBs may be designated in the same country.
- These NBs may have specific areas of expertise.
An MD manufacturer is free to choose any NB it wishes, provided the MD to be assessed falls within the scope of the body's competence.