The EUDAMED will be mandatory to use as from 28 May 2026

The EUDAMED will be mandatory to use as from 28 May 2026

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, […]

Guidance on Unique Device Identification (UDI) System

Guidance on Unique Device Identification (UDI) System

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 […]