MDGC Publishes Guidance on Performance Studies for IVDs
MDCG Guidelines, Performance Studies, In vitro diagnostic Medical Devices Elisabethann Wright MDCG Guidelines, Performance Studies, In vitro diagnostic Medical Devices Elisabethann Wright

MDGC Publishes Guidance on Performance Studies for IVDs

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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