The Medicines and Healthcare products Regulatory Agency (MHRA) announced the release of a suite of post-market surveillance (PMS) guidance (January 15) in alignment with The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
Background
As Emergo by UL reported last month, the amendment introduces new and enhanced PMS requirements for manufacturers that supply medical devices in Great Britain (GB). Additional regulatory updates were posted to the Emergo by UL website comparing the new PMS requirements between GB and EU in terms of vigilance and PMS. Manufacturers are encouraged to review the new guidance well in advance of when the statutory instrument comes into force, June 16.
MHRA Releases Suite of Guidance for New Post-Market Surveillance Regulation
MHRA Releases Suite of Guidance for New Post-Market Surveillance Regulation
The Medicines and Healthcare products Regulatory Agency (MHRA) announced the release of a suite of post-market surveillance (PMS) guidance (January 15).
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