New Q&A released on the gradual roll-out of EUDAMED

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.

Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical device.

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.