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New EUDAMED Q&A published
The European Commission has updated its Q&A on the gradual EUDAMED roll-out. A short overview of how the staggered approach works and what manufacturers should do now.
The European Commission has released an updated Q&A document on the gradual roll-out of EUDAMED, now accompanied by a helpful flowchart.
Gradual Implementation
EUDAMED modules will be introduced progressively, following independent audits and confirmation of functionality. Each module becomes mandatory 6 months after the publication of a notice in the Official Journal of the EU.
Devices must be registered either from the applicable date or upon relevant vigilance actions. The staggered approach aims to enhance transparency and safety across the MedTech sector. The new flowchart was developed by MedTech Europe and adopted with minimal changes.
Manufacturers, importers, and Authorised Representatives are encouraged to register early to ensure a smooth transition.
If you need support with the registration process or navigating the new requirements, feel free to reach out to us at info@eumediq.eu. Read more here.
KEY TAKEAWAY
The European Commission has released an updated Q&A document on the gradual EUDAMED roll-out, accompanied by a flowchart.
EUDAMED modules will be introduced progressively following independent audits, with each module becoming mandatory six months after a notice is published in the Official Journal. Devices must be registered either from the applicable date or upon relevant vigilance actions, and the staggered approach is intended to enhance transparency and safety across the sector. Manufacturers, importers, and Authorised Representatives are encouraged to register early.
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