The United Kingdom has recently implemented strict regulations applicable to the post-market surveillance (PMS) of medical devices.
According to a press release on the country’s government website, the new PMS regulations will require device manufacturers to proactively track the performance and safety of their products. The new regulations, which took effect on June 16th, apply to all UKCA- and CE-marked devices placed on the market after June 16th, including in vitro diagnostic devices (IVDs), active implantable medical devices, and other medical device technologies intended for use in healthcare settings and in-home care.
Specifically, the new PMS regulations will require medical device manufacturers to:
- Gather and assess data on how their medical devices perform in daily use, to help increase their ability to detect safety and performance issues;
- Expand incident reporting, including serious incidents relating to side effects associated with the use of their medical device;
- Leverage new data analysis reporting options to support earlier detection of trends; and
- More proactively assess and manage risks and promptly notify users when safety issues arise.
The UK government’s press release on its new post-market surveillance regulations is available at https://www.gov.uk/government/news/first-major-overhaul-of-medical-device-regulation-comes-into-force-across-great-britain.
A detailed summary of the new requirements as implemented by the UK’s Medicines & Healthcare products Regulatory Agency is available at https://www.gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/implementation-of-the-future-regulations#post-marketsurveillance-requirements.
