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 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, […]
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.
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 […]
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