The ???????????????????????????? ???????????????????????????? (????????????????-???????????????????????? ???????????????????????????????????????????????? ????????????????????????????????????????????????) (????????????????????????????????????) (???????????????????? ????????????????????????????) ???????????????????????????????????????????? ???????????????? 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.
???????????? ???????????????????????????????????????? ????????????????????????????:
???????????? ???????????????????????? ???????????? ????????????????: Manufacturers must establish a PMS system and develop a detailed plan for ongoing monitoring of their devices.
???????????????????????????????? ????????????????????????????????????: Obligations are set for reporting serious incidents and trends, with specific timelines for initial and final reports.
???????????????????????????????????????? ???????????? ???????????????????????????????????????? ????????????????????????????: Manufacturers are required to implement measures to address potential or actual non-conformities, including field safety corrective actions.
???????????????????????????????????????????????????? ????????????????????????????????????: 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.
???????????????? 4???? of The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: https://www.legislation.gov.uk/uksi/2024/1368/regulation/4/made
???????????????????????????????? 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