CE marking
Facilitating access to CE marking
What is the purpose of this action?
This action should help identify the obstacles to CE marking and propose action levers, in line with all the actions of the "eHealth" acceleration strategy and France's medical devices plan
Who is it for ?
• Notified bodies
• Companies in the field of eHealth
Issue
This action aims to continue the dialogue with the French notified bodies on identifying obstacles to their growth in the field of eHealth in order to implement the necessary measures.
The new European MDR and IVDR regulations (2017/745 and 746) require, among other things, that staff in charge of regulatory affairs at NBs, manufacturers and agents be increased. Several hundred jobs are expected to need filling in the years to come.
It therefore appears essential to promote the rise of French NBs that specialize in digital technology to facilitate access to CE marking for software and connected medical devices.
Description
This action is linked to the actions:
Roadmap of the action
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2022-2025
Setting up of financing, training modules, pursuit of regular dialogue with the NBs and the training players
