UK MedTech: Dual Mandate – Patient Safety & Data Privacy After the 2025 PMS Regulations
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UK MedTech: Dual Mandate – Patient Safety & Data Privacy After the 2025 PMS Regulations
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About this listen
Welcome to Global Privacy Deep Dive, your deep dive into the world of global data law and compliance. Presented by Annie and Rob.
The regulatory landscape for medical devices in Great Britain has just been fundamentally reshaped. Effective June 16, 2025, the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 or ( UK MedTech PMS Regulations 2025 ) introduce a mandate for manufacturers to intensify their monitoring efforts once devices are on the market. The goal is clear: faster detection of safety issues and better containment of risk.
However, this commitment to patient safety creates a complex challenge for data privacy and compliance teams. Increased monitoring means more data collection, heightened retention risks, and faster reporting requirements, all of which must be reconciled with the UK’s stringent data protection laws (UK GDPR).