REGULATORY AUTHORITY: Devices are regulated by the EU list of Competent Authorities. In France, devices are also regulated by the National Agency for the safety of Medicines and Health Products (ANSM).
CLASSIFICATION SYSTEM: Medical devices are classified according to risk into Classes I, IIa, IIb and III.
TIMEFRAME: The EU registration process takes about 4-6 weeks after submission for Class I devices. For the other classes, it depends on the contract with the notified body and the type of device. Approval from ANSM typically takes 2-3 weeks.
LICENSE VALIDITY: Licenses issued in the EU are valid for five years. ANSM registration does not expire; only one communication per device is necessary.
AUTHORIZED REPRESENTATIVE: An authorized representative located in the EU, but not necessarily in France, is required.
ADDITIONAL INFORMATION: On April 5, 2017, two new Regulations on medical devices were adopted, these entered into force on May 25, 2017 and replaced the existing Directives. The new rules will only apply after a transitional period, namely, 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
Class IIa, IIb, III AIMDs and MDs and class I sterile MDs or those with a measurement function & IVDs specified in annex II of directive 98/79/CE, as well as those intended for self-diagnosis, should be registered in the French competent authority before being placed in the French market.
