In July 2026, the Medical Device Coordination Group (MDCG) published MDCG 2026-5 – Position Paper on UDI Assignment Between Manufacturers and Distributors. This position paper…
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Updated EUDAMED features: EAR to be notified of new Basic UDI
EUDAMED has recently introduced new features to their system. The database is regularly subject to improvements and updates. In the latest release, EUDAMED has several…
Master UDI-DI for spectacle frames and lenses
On 23 September 2025, the Official Journal of the EU published Commission Delegated Regulation (EU) 2025/1920. This Regulation amends Part C of Annex VI of…
MDCG on timelines to implement Master UDI-DI
On 10 July 2025, the Medical Device Coordination Group (MDCG) released a position paper to clarify the timelines of the implementation of the Master UDI-DI…
Practical guidance on UDI requirements: examples and terms
Date of UDI guidance: June 2025 The Unique Device Identification (UDI) system under the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation…
New MDCG Guidance on performance studies of IVDs
In June 2025, the Medical Device Coordination Group (MDCG) published a new guidance document on performance studies of in vitro diagnostic medical devices under Regulation…
26 May 2025: UDI labelling deadline for medical devices and IVDs in the EU
To comply with the EU Medical Devices Regulations (MDR and IVDR), an important deadline is approaching for labels of medical devices and IVDs. From 26…
New MDCG Guidance on Master UDI-DI for contact lenses
The Medical Device Coordination Group (MDCG) just published a new MDCG guidance document on the implementation of the Master UDI-DI solution for contact lenses. MDCG…
Harmonised standards for aseptic processing and clinical performance studies
On 9 October 2024, the European Commission published new harmonised standards in support of the EU medical devices Regulations (MDR and IVDR). These new standards…
Challenges for combined studies of medicines, IVDs, and devices
In the European Union, there are different regulatory requirements for clinical trials of medicinal products, clinical investigations of medical devices, and performance studies of IVDs.…