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…
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…
New MDCG Guidance on IVDR legacy requirements and Q&A on UDI!
The Medical Device Coordination Group (MDCG) has released two very useful guidances: one concerning the application of IVDR requirements to “legacy devices” and devices placed…
MDCG Guidance note: UDI within organization’s QMS
The MDCG has released a new Guidance note on how to implement the MDR / IVDR requirements related to the Unique Device Identification (UDI) system…