The 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞𝐬 (𝐏𝐨𝐬𝐭-𝐦𝐚𝐫𝐤𝐞𝐭 𝐒𝐮𝐫𝐯𝐞𝐢𝐥𝐥𝐚𝐧𝐜𝐞 𝐑𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬) (𝐀𝐦𝐞𝐧𝐝𝐦𝐞𝐧𝐭) (𝐆𝐫𝐞𝐚𝐭 𝐁𝐫𝐢𝐭𝐚𝐢𝐧) 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧𝐬 𝟐𝟎𝟐𝟒 introduce new post-market surveillance (PMS) obligations for medical device manufacturers in Great Britain by adding Part 4A, which outlines requirements for monitoring device performance and safety after market introduction.
𝐊𝐞𝐲 𝐜𝐨𝐦𝐩𝐨𝐧𝐞𝐧𝐭𝐬 𝐢𝐧𝐜𝐥𝐮𝐝𝐞:
𝐏𝐌𝐒 𝐒𝐲𝐬𝐭𝐞𝐦 𝐚𝐧𝐝 𝐏𝐥𝐚𝐧: Manufacturers must establish a PMS system and develop a detailed plan for ongoing monitoring of their devices.
𝐈𝐧𝐜𝐢𝐝𝐞𝐧𝐭 𝐑𝐞𝐩𝐨𝐫𝐭𝐢𝐧𝐠: Obligations are set for reporting serious incidents and trends, with specific timelines for initial and final reports.
𝐏𝐫𝐞𝐯𝐞𝐧𝐭𝐢𝐯𝐞 𝐚𝐧𝐝 𝐂𝐨𝐫𝐫𝐞𝐜𝐭𝐢𝐯𝐞 𝐀𝐜𝐭𝐢𝐨𝐧𝐬: Manufacturers are required to implement measures to address potential or actual non-conformities, including field safety corrective actions.
𝐃𝐨𝐜𝐮𝐦𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧 𝐑𝐞𝐭𝐞𝐧𝐭𝐢𝐨𝐧: Manufacturers must retain relevant documentation for a specified period to ensure traceability and accountability.
These measures aim to enhance patient safety by ensuring continuous monitoring and prompt action regarding medical devices post-market.
𝑷𝒂𝒓𝒕 4𝑨 of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: https://www.legislation.gov.uk/uksi/2024/1368/regulation/4/made
𝑮𝒖𝒊𝒅𝒂𝒏𝒄𝒆 of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: https://www.gov.uk/government/publications/medical-devices-post-market-surveillance-requirements/the-medical-devices-post-market-surveillance-requirements-amendment-great-britain-regulations-2024-guidance-on-implementation