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UDI

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MDR, UDI

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…

September 24, 2025
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Georgios 2025-09-24T09:42:51+02:00
IVDR, MDR, UDI

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…

March 25, 2025
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Simona Varrella 2025-03-25T18:23:52+01:00
MDR, UDI

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…

November 27, 2024
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Simona Varrella 2024-11-27T09:54:18+01:00
IVDR, MDR, UDI

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…

May 23, 2022
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regulatory26@obelis.net 2022-05-23T11:54:31+02:00
IVDR, MDR, UDI

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…

July 15, 2021
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Webmasters 2021-07-15T16:47:02+02:00

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