New UK Post-Market Surveillance RequirementsNew UK Post-Market Surveillance RequirementsNew UK Post-Market Surveillance RequirementsNew UK Post-Market Surveillance Requirements
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New UK MHRA Vigilance Portal
May 16, 2023
Swiss Importer Identified with IVD Devices
May 16, 2023

New UK Post-Market Surveillance Requirements

May 16, 2023

The MHRA will implement new post-market surveillance (PMS) requirements in Great Britain, prior to the release of the new Regulation (currently expected July 2025). 

 

The PMS legislation is expected to be published in 2023, followed by a transition period. The anticipated implementation deadline is sometime in mid-2024. 

 

NOTE: the PMS requirements will be applicable for both UKCA and CE Marked devices.

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