CE marking
Fluidifying access to CE marking
What is the objective of the action?
This action should make it possible to identify the obstacles to CE marking and propose levers for action, in conjunction with all the actions of the "Digital health" acceleration strategy and France's DM Plan
.Who is it for ?
- To notified bodies
- To companies in the digital health field
Issues
The aim of this action is to continue the dialogue with French notified bodies on identifying the obstacles to their growth in the digital health field, so that the necessary measures can be put in place accordingly.
The new European DM and DMDIV regulations (2017/745 and 746) require, in particular, the reinforcement of staff responsible for regulatory affairs at NBs, manufacturers and agents. Several hundred jobs are expected to be filled in the coming years.
It therefore seems capital to encourage the rise of French NBs with a specialization in digital to enable smoother access to CE marking for software and connected medical devices.
Description
This action is linked to the following actions:
Action roadmap
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2022-2025
Financing, training modules, ongoing dialogue with NAOs and training stakeholders
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