Regulatory Authority
Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM).
Classification
I, IIa, IIb, III
Quality system
ISO 13485:2016
All Medical Devices must bear the CE marking in order to be marketed in France.
In the case of a non-European Manufacturer, an Authorised Representative or Representative must be appointed.
For Class I MDs, sterile, measuring function, custom-made devices, kits, systems, sterilisation of devices and accessories, the Manufacturer or the Authorized Representative must send a statement to the Regulatory Authority enclosing the required documentation.
For Class IIa, IIb, III and AIMDs (Active Implantable Medical Devices), the Manufacturer or the Authorized Representative must send a notification to the Regulatory Authority by submitting the required documentation before marketing the device.
Applicant
Authorized Representative or Manufacturer.
Timeframe and fees
Time: about 2-3 weeks.
There are no costs for declaration or notification.
Validity
Validity of the CE marking: 5 years.
Labelling and documentation language
Documentation and labelling must be provided in French.
Useful information
The website of the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) is constantly updated in French.
Like all the Countries of the European Union, France will also adopt the New Regulation (EU) 2017/745 on Medical Devices. It is recalled that such Regulation, approved on April 5, 2017, is then entered into force on May 26, 2017. The full implementation of the New Regulation will take place on May 26, 2021.
