Devices are regulated by the EU list of Competent Authorities. In France, medical devices are also regulated by ANSM (National Agency for Medicines and Health Products Safety) under the Direction de l’évaluation des dispositifs médicaux
. CLASSIFICATION SYSTEM:
Medical devices are classified according to risk into Classes I, IIa, IIb, III, and IV. 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:
The EU Medical Device Directive is due to be changed in 2015.
Last updated on March 9 2015.
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For more information on registration in France and the EU, check out the following articles on our blog: Country at a Glance: France 5 Questions and Answers: Additional Regulations in the EU 4 Steps to Comply With EU Directive RoHS 2