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A deep dive on new UK post-market surveillance rules

The UK government recently released a draft copy of a statutory instrument which will introduce new post-market surveillance (PMS) rules for medical devices in Great Britain (UK PMS Regulation).

Manufacturers will need to be alive to these differences as they prepare new UK MDR-compliant PMS plans for devices which will be placed on the market in Great Britain from July 2024.

In the latest article, Jamie Hatzel discusses 'more substantive differences between the UK PMS Regulation and the EU MDR PMS' and the 'small technical differences which manufacturers should review when preparing a PMS plan for Great Britain.'

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uk pms regulation, wto, fsca, ce marked devices, eu pms system, brexit, health tech, life sciences, life sciences regulatory, technology