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The Formiti Global Data Privacy Podcast

UK MedTech: Dual Mandate – Patient Safety & Data Privacy After the 2025 PMS Regulations

UK MedTech: Dual Mandate – Patient Safety & Data Privacy After the 2025 PMS Regulations

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 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.