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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. BackgroundAs Emergo by UL reported last month, the amendment introduces new and enhanced PMS requirements for manufacturer..

BackgroundThe 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 Diagno..

Draft requirements for post-market surveillance (PMS) of medical devices in the U.K. align closely with European regulations, but not entirely. Below, Emergo by UL continues our analysis of the proposed legislation. As noted in a previous Regulatory Update, a draft post-market surveillance statutory instrument (PMS SI) was laid in the U.K. Parliament (October 21) to introduce new PMS and vigilan..

BackgroundFollowing 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 stricte..

Background on post-market surveillance globallyPMS has been a pivotal topic. The European regulations (Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR)) officially defined the term PMS (Article 2(60)). In 2019, the U.S. FDA introduced the term Total Product Life Cycle (TPLC) as a "holistic” perspective with the FDA throughout the entire lifec..

1. Introduction Article 120 of the Medical Device Regulation (EU) 2017/745 (MDR), as amended by Regulation (EU) 2023/607, states that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of a..