Background
Following the publication of the draft PMS SI on the World Trade Organization (WTO) website on July 26, 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) has, after considering stakeholder responses to that draft, published the “final” draft PMS SI.
This instrument introduces new PMS requirements for medical devices that improve patient safety by establishing stricter surveillance obligations on manufacturers to ensure continuous monitoring of device performance, safety and quality after they are placed on the market.
MHRA Publishes Draft Post-Market Surveillance Requirements
MHRA Publishes Draft Post-Market Surveillance Requirements
The draft Post-Market Surveillance statutory instrument (PMS SI) was laid (Oct. 22,) in parliament.
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