MDCG Guidance on post-market surveillance of Medical Devices and In Vitro Diagnostic Medical Devices
Medical Devices, In vitro diagnostic Medical Devices, Post-Market Surveillance Elisabethann Wright Medical Devices, In vitro diagnostic Medical Devices, Post-Market Surveillance Elisabethann Wright

MDCG Guidance on post-market surveillance of Medical Devices and In Vitro Diagnostic Medical Devices

In its last publication of 2025, MDCG 2025-10, the Medical Device Coordination Group (MDCG) provides guidance to manufacturers concerning the post-market surveillance (PMS) obligations imposed by the Medical Devices Regulation (MDR) and the in vitro diagnostics Medical Devices Regulation (IVDR) and the appropriate steps to ensure that these are fulfilled.

The Guidance recalls

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UK Regulations Governing Post-Market Surveillance of Medical Devices Enter Into Force
Medical Devices, Post-Market Surveillance, MHRA, In Vitro Diagnostic, Implantable Medical Devices Elisabethann Wright Medical Devices, Post-Market Surveillance, MHRA, In Vitro Diagnostic, Implantable Medical Devices Elisabethann Wright

UK Regulations Governing Post-Market Surveillance of Medical Devices Enter Into Force

The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 entered into force on 16 June 2024. The Regulations, which apply in Great Britain, introduce a new Part 4A to the existing Regulations governing post-market surveillance (PMS) requirements for medical devices. These include in vitro diagnostic (IVD) devices and active implantable medical devices.

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