A Commission Decision entering into force on 27 November confirmed that certain electronic systems meet their required functional specifications. This decision has triggered a six-month transition period, as outlined in the Regulation governing EUDAMED’s gradual roll-out. This would mean that the following modules will become mandatory 6 months after this publication. This would make the … Read more
Over the past few months, a member of the Advena Team has participated in several training sessions and workshops organized by the European Commission focusing on the implementation of EUDAMED — the European Database on Medical Devices. These sessions provided valuable insights into the system’s structure, functionality, and the upcoming regulatory requirements for economic operators. … Read more
The European Commission has released a revised timeline for the gradual rollout of the European Database on Medical Devices (EUDAMED), reflecting the current consultation status with the Medical Device Coordination Group (MDCG) and recent policy updates. This timeline clarifies key milestones for stakeholders and provides crucial visibility into when the different EUDAMED modules are expected … Read more
The European Commission is hosting a free hybrid workshop in Stuttgart to support onboarding to EUDAMED, the EU’s database for medical devices. The event will guide stakeholders—such as economic operators, notified bodies, and national authorities—on meeting their obligations under the MDR and IVDR, particularly regarding EUDAMED’s mandatory modules (Actors, UDI/Devices, Notified Bodies and Certificates, Market … Read more
The EU Commission has published a roadmap to illustrate the current planning for the gradual roll-out of EUDAMED. This roadmap is intended to give the relevant actors estimated timeframes of when each module will become mandatory for use. According to the roadmap published, the notice for the Actor, UDI/Devices, NB & Certificates and Market Surveillance … Read more
The EU Parliament has also adopted the proposal regarding the gradual roll-out of EUDAMED which will facilitate the launch of parts of the Database. This means that the mandatory use of several parts of EUDAMED will start from as early as Q4 of 2025/Q1 of 2026. This gradual roll-out of EUDAMED will help increase transparency … Read more
The EU Commission seemed to have confirmed a delay to the mandatory implementation of EUDAMED by posting a new draft timeline to its website. The draft timeline indicates that all six of the modules will not be in a position to undergo independent audits before Q4 of 2026, this is primarily due to the Clinical … Read more
This month sees an updated EUDAMED, version 2.12 was deployed on 20th September 2023. It is important that all actors keep informed regarding these changes and how they may affect the use of EUDAMED. The release notes detailing new and updated elements can be found here: [Release Notes v2.12] The EUDAMED user guide for Economic … Read more
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