EUDAMED Webinars by EU Commission
In preparation for the mandatory implementation of EUDAMED, the European Commission is offering a series of training courses covering key modules. These modules will become mandatory as of 28 May 2026. We strongly encourage our clients to attend these sessions, as they provide valuable guidance on how to use EUDAMED effectively and help ensure you ...
EUDAMED to Become Mandatory as from 28th May 2026
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 ...
EUDAMED Training Updates and Key Implementation Timelines
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. ...
MDCG 2024-15 Guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED
A guidance document has been released on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED. To offer some background to this guidance document, Article 77(5) of the MDR mandates that sponsors submit a clinical investigation report to the Member States where the clinical investigation was conducted within one ...
EU Commission Release Q&A regarding Gradual Rollout of EUDAMED
The European Commission has recently released a comprehensive Q&A document designed to assist manufacturers and other stakeholders in understanding the new amendment concerning the phased implementation of EUDAMED. This amendment, introduced through Regulation (EU) 2024/1860, was published in mid-June and addresses three key areas within the framework of the Medical Device Regulation (MDR) and In ...
EU Parliament Adopts the Proposal Put Forward by the EU Commission Regarding the Gradual Roll-out of EUDAMED
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 ...
EU Commission Proposes Gradual EUDAMED Rollout
The EU commission is proposing making some of the EUDAMED modules mandatory at an earlier stage, by Quarter 4 of 2025. Under the current legislation, EUDAMED will become mandatory when all 6 modules are functional, which due to some delays in the development of the module for clinical investigations/performance studies, would be late 2029. Under ...
