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, […]
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 […]
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