The European Medical Device Coordination Group (MDCG) has published a comprehensive Q&A document detailing the gradual implementation of Eudamed under the MDR (2017/745) and IVDR (2017/746) regulations, aligned with the latest amendments in Regulation (EU) 2024/1860. This essential guidance includes:
📌 Gradual Module Roll-Out: Modules like Actor, UDI/DEV, Certificates, Market Surveillance, Post-Market Surveillance, and Clinical Investigations will be activated progressively.
📌 Transition Periods: Mandatory timelines for economic operators, notified bodies, and competent authorities to comply with the new system.
📌 Improved Transparency: Centralized registration ensures streamlined monitoring of devices and actors in the EU market, bolstering patient safety and supply chain reliability.
📌 New Obligations: Requirements for notifying competent authorities about supply interruptions or device discontinuation to mitigate healthcare risks.
📌 Action Steps for Stakeholders:
- Register in relevant modules early to ensure compliance.
- Stay updated on functionality notices published in the Official Journal of the EU (OJEU).
🔗 Read the full document: https://health.ec.europa.eu/latest-updates/gradual-roll-out-eudamed-qas-practical-aspects-related-implementation-regulation-eu-20241860-2024-11-21_en
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