Great Britain's Draft Post-market Surveillance Requirements Compared to EU Requirements on Vigilance

By Beth Pugh, Karen Hill and Evangeline Loh

Draft requirements for post-market surveillance (PMS) of medical devices in Great Britain (GB) 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 British 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 GB legislation.

Serious Incident Reporting in the PMS SI

Analogous to the EU requirements, the GB legislation introduces the term “Serious Incident”. British regulators also reduce their reporting timeframe for reportable serious incidents from 30 days to within 15 days. The timeframe for serious public health threats and death or unanticipated serious deterioration in state of health remain the same (two and 10 days, respectively).

Periodic Summary Reports (PSR) and Trend Reports in the PMS SI

The PSR and trend report requirements appear to be identical to the EU requirements under the Regulations.

FSCA Reporting in the PMS SI

Similar to the EU Regulations, field safety corrective actions (FSCAs) must be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) prior to initiating a FSCA except in cases of urgency. MEDDEV 2.12/1, which is the vigilance guidance document currently used in GB, only suggests allowing the competent authority(ies) 48 hours to review the FSN content prior to dissemination.

The notification of a FSCA in GB includes some additional requirements. Like many other markets including the EU, the U.K. will require a risk assessment be performed. One added requirement specific to GB requires that initial FSCA reports include the number of devices placed on the market or put into service, and the estimated number of users affected.

In Emergo’s opinion, one of the more notable differences involves FSCAs undertaken in other markets. Unlike the EU Regulations, GB legislation will require the manufacturer to report FSCAs undertaken in other markets if the FSCA relates to a device which is of the same model as the device that has been placed on the market or put into service in GB and the manufacturer is not taking the same action in GB.

Responding to MHRA Requests 

There is a requirement to provide MHRA with requested updates and documents relevant to an investigation of a serious incident, trend report or FSCA within three working days of any such request.

Concluding Remarks

Once the PMS SI comes into force in GB, general vigilance requirements will align more closely with those in the EU. Medical device and IVD companies active in the GB market will need to adjust their compliance processes to cover PMS and vigilance requirements specific to the new legislation, as well.