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 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 […]
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