According to the Medical Devices legislation, old and custom-made devices (OCM) are not to be registered in the UDI/Devices module but are to be referenced in Vigilance dossiers. Old Device: Devices placed on the market according to the medical devices Directives or the in vitro diagnostic medical devices Directive before the date of application of the MDR and IVDR or placed on the market before […]
Following official announcements, the deadline for medical device manufacturers to register their MDR and MDD compliant products in the EUDAMED database is set for May 28, 2026, and November 28,2026. As these mandatory deadlines approach, organizing your product data now is critical to ensuring a seamless transition and maintaining compliance. Selecting the Right Data Upload Method When deciding on an upload strategy for EUDAMED, the […]
The new version (v3) of EMDN Codes for 2026 is available in EUDAMED with the deployment of Production v2.22.0. The release of v2.22.0 took place at the end of January 2026. The full documentation of the release is also available in the Information Centre – EUDAMED.
The Commission Decision (EU) 2025/2371 of 26 November 2025 on the notice regarding the functionality and the fulfilment of the functional specifications of certain electronic systems included in the European Database on Medical Devices declaring the functionality of the first four modules has been published in the Official Journal of the European Union (OJEU) of 27 November 2025. In accordance with the transitional provisions set out in Regulation (EU) 2024/1860, […]
Please click here to view “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 […]
The module on UDI/devices registration (second module) and the module on Notified Bodies and Certificates (third module) are available since October 2021 except for the mechanism for scrutiny and the clinical evaluation consultation procedure (CECP) functionalities. Afterwards, the remaining modules as well as the mechanism for scrutiny and the CECP will be released when EUDAMED is fully functional.
Countries available in EUDAMED Which national competent authorities will be registered in EUDAMED Actor module The national competent authorities from EU 27, Iceland, Liechtenstein, Norway and Turkey are registered in EUDAMED as well as the UK competent authorities in respect of Northern Ireland. Concerning other third countries national competent authorities, the Commission may in principle be able to register them in the actor module from […]
The Medical Devices Regulation (MDR, Regulation (EU) 2017/745) is fully applicable since 26 May 2021, following the transition period. Please keep the revised deadline firmly in mind. The corresponding date of application of the In Vitro Diagnostic Medical Devices Regulation (IVDR, Regulation (EU) 2017/746) remains in May 2022. If you manufacture, distribute or procure medical devices, or have other responsibilities under the new Regulations, please take advantage of […]
The new Medical Device Regulations MDR (EU) 2017/745 and IVDR (EU) 2017/746 introduce a Unique Device Identification (UDI) system for medical devices. Main provisions related to the establishment of the UDI system are contained in Chapter III and Annex VI of the two medical device Regulations. Overview of the MDR (EU) 2017/745 UDI and device data sets and IVDR (EU) 2017/746 UDI and device data sets to […]
Countries available in EUDAMED from December 2020 Which national competent authorities will be registered in EUDAMED Actor module from December 2020? As of December 2020, the national competent authorities from EU 27, Iceland, Liechtenstein and Norway will be registered in EUDAMED. Concerning other third countries national competent authorities, the Commission may in principle be able to register them in the actor module from a later […]
Recent Comments