New MDCG position paper released on the timelines of implementation of Master UDI-DI to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles
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New MDCG position paper released on the timelines of implementation of Master UDI-DI to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles
Regulatory Affairs Medical Devices
Tuesday, 30 September 2025
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On 10 July 2025, the Medical Device Coordination Group (MDCG) released a new position paper ( MDCG 2025-7) on the timelines of the implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles
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New MDCG position paper released on the timelines of implementation of Master UDI-DI | QbD Group
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The paper explains how the Master UDI-DI solution, introduced through recent Delegated Regulations, is intended to address the high level of individualisation of such devices by grouping them under a common identifier in EUDAMED. This approach is designed to ease the regulatory burden by avoiding the proliferation of identifiers for similar devices, while ensuring traceability and compliance with the MDR. MDCG 2025-7 clarifies the applicable timelines, the labelling obligations for the Master UDI-DI, the requirement to use the UDI/Device registration module of EUDAMED, and how these obligations interact in practice.
What does this mean for you?
Manufacturers of these devices should review their UDI strategies to ensure compliance with the new grouping approach. Early planning and system updates may be needed to meet labelling and registration obligations efficiently.
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Should you want to discuss this more in-depth with one of our consultants, please do not hesitate to contact us.
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