Background
The draft PMS SI was initially shared on July 26, 2023, after the publication of the draft PMS SI on the World Trade Organization (WTO) website by the UK regulator MHRA. The revised final draft was shared again on October 22.
The intent has always been to emphasize the importance of PMS, analogous to the European regulations (Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostics Devices Regulation 2017/746 (IVDR)). However, as the UK exited during BREXIT, a legislative mechanism was needed to address this.
MHRA Finalizes Post-Market Surveillance Requirements | Emergo by UL
MHRA Finalizes Legislation on Post-Market Surveillance Requirements
The UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) finalized the Post-Market Surveillance statutory instrument (PMS SI) in December 2024. Medical device manufacturers doing business in the UK will want to famili
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