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 vigilance requirements for medical devices and in vitro diagnostic (IVD) products. Following our examination of the PMS and periodic safety update report (PSUR) elements of the proposed legislation, we now discuss the vigilance component of the PMS SI.
Comparison Between PMS SI and EU Regulations
Although the PMS SI tracks closely to the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), medical device and IVD manufacturers should be aware of some significant differences regarding vigilance requirements in the draft U.K. legislation.
UK medical device and IVD PMS news
U.K. Draft Post-market Surveillance Requirements Compared to EU Requirements on Vigilance
Emergo by UL examines proposed post-market surveillance and vigilance requirements in the U.K. versus Europe in the last of our three-part series.
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