On July 26th, 2023, the UK revised the post-marketing regulatory requirements for medical devices. The main contents of this revision include:
(1) increasing the scope of equipment that must meet the requirements of post-marketing supervision (PMS), including equipment with CE mark;
(2) Define the detailed information of the content that PMS system must contain, including the method of collecting PMS data, so as to support the improvement of PMS data acquisition and coordination among manufacturers;
(3) Strengthen manufacturers' obligation to report serious accidents, so as to find safety problems more quickly;
(4) Make stricter requirements on manufacturers and regularly review their PMS data, including the PMS data of implantable medical devices.
The deadline for notification and review is 60 days from the date of notification and release.
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