Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On November 21st, 2024, the Medical Device Coordination Group (MDCG) released a Q&A on the gradual roll-out of EUDAMED. This document provides a Q&A related to the implementation of the gradual roll-out of EUDAMED pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860.
Some key takeaways from the Q&A
The Q&A provides timelines and conditions for the activation and mandatory use of EUDAMED modules:
- Actor module,
- UDI/Device module,
- Notified bodies and certificates module,
- Market surveillance module,
- Post-market surveillance and Vigilance module,
- Clinical investigations/performance studies module.
It also clarifies the timelines for their implementation and the conditions under which stakeholders can or must use these modules. To enhance understanding, the document includes examples of transition periods and offers detailed guidance on managing obligations during the roll-out phase.
What does it mean to you?
This publication provides critical information for stakeholders in the medical device and in vitro diagnostic industries.
By aligning with the phased roll-out, stakeholders can proactively manage their responsibilities and contribute to the broader goals of harmonization and enhanced oversight within the EU’s medical device and diagnostics framework.
关于作者
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
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