Periodic summary reports submitted to the MHRA as a post market surveillance condition of exceptional use authorisation DEU/012/2020/003

Question 1

Background

Accepted Answer

The Department of Health and Social Care (DHSC) and UK Health Security Agency (UKHSA), as an executive agency of DHSC, are responsible for UK-wide public health protection and infectious disease testing capability.

In response to the COVID-19 pandemic, DHSC developed and distributed a DHSC COVID-19 self-test NHS lateral flow device (LFD) kit for the detection of COVID-19 infection. The DHSC is, and remains, the legal manufacturer of these DHSC COVID-19 self-test LFD kits.

UKHSA was established in October 2021, and the duties associated with being a legal manufacturer were undertaken by UKHSA on behalf of DHSC, including responsibilities for delivering the regulatory requirements. The DHSC COVID-19 self-test kit is an in vitro diagnostics (IVD) medical device. This device was supplied in the United Kingdom under an exceptional use authorisation which was granted by the Medicines and Healthcare products Regulatory Agency (MHRA) on 22 December 2020 under reference DEU/012/2020/003.

A manufacturer can apply for an exceptional use authorisation from the MHRA to supply a medical device that is not UKCA/CE marked where there is a clear clinical need for the device, and there is no available supply of UKCA/CE marked alternatives. An exceptional use authorisation under the UK Medical Device Regulations is always granted subject to conditions, which will include a requirement for the manufacturer to monitor the safety of its device and report regularly to the MHRA. DHSC was granted the exceptional use authority on the condition that they submit reports to the MHRA every 2 weeks detailing any adverse incidents, and the number of devices supplied and to whom, and monthly post market surveillance reports.

The exceptional use authorization expired 30 June 2023 and DHSC and UKHSA no longer distribute this product.

DHSC, and subsequently UKHSA, performed post market surveillance activities to collect customer feedback on the performance and safety of the DHSC COVID-19 self-test kit device.

Post market surveillance is defined by the World Health Organization (WHO) as:

a set of activities conducted by manufacturers, to collect and evaluate experience gained from medical devices that have been placed on the market, and to identify the need to take any action. Post-market surveillance is a crucial tool to ensure that medical devices continue to be safe and well-performing and to ensure actions are undertaken if the risk of continued use of the medical device outweighs the benefit. The evaluation of post-market surveillance experiences can also highlight opportunities to improve the medical device.

DHSC, and subsequently UKHSA, provided the MHRA with periodic summary reports. These reports outlined, analysed and reported on the post market surveillance activities that were undertaken to ensure the performance and safety of the DHSC COVID-19 self-test kit until its expiry in January 2024. This is a formal regulatory process, and the periodic summary reports are technical documents.

Some key post market surveillance processes include:

Question 2

Complaint handling

Accepted Answer

Test kit users were encouraged to give feedback about their DHSC COVID-19 self-test kit, and report if they had been harmed or had a reaction using the test kit via an online survey, 119 or the MHRA Yellow Card reporting site.

Report harm or give feedback about your test

The Yellow Card reporting site

UKHSA used this data to identify if there were any trends in the types of complaints being reported, and if any further action could be taken. For example, when multiple complaints were received regarding missing components, UKHSA liaised with the test kit supplier to ensure that corrective action was taken.

Question 3

Non-conformance management, including CAPA and SCAR

Accepted Answer

When UKHSA identified a trend in performance data or complaints data that suggested there may be an issue, UKHSA raised CAPAs (corrective action and preventive actions – internal against UKHSA processes) or SCARs (supplier corrective action reports – external against the supplier).

UKHSA used these reports to formally record their investigations into potential issues. UKHSA prides itself on setting high best practice quality standards, and therefore had a low threshold for initiating the investigation of any potential nonconformities. As a result, a high proportion of CAPAs raised were quickly closed after thorough investigations concluded that corrective or preventative action was not necessary. Monitoring and early identification of potential issues is considered to be effective non-conformance management and good practice quality continuous improvement.

The post market surveillance monitoring activities were implemented as part of DHSC’s legal manufacturer regulatory and quality responsibilities for the DHSC COVID-19 self test LFD. It is important to note that a clinical governance and quality structure was embedded within the testing service, and these activities covered all LFDs distributed by DHSC, with post market surveillance data being passed to the appropriate legal manufacturer. A summary of quality processes adhered to during the pandemic is available at COVID-19: striving for quality in the national testing service

See also Evaluation of the national COVID-19 testing programme in England between October 2020 and March 2022 for in-depth policy timelines.

Table 1. Key dates in the evolution of the periodic summary reports

Date	Overview of change
December 2020	Exceptional use authorisation granted by MHRA reference DEU/012/2020/003.
January 2021	Onsite school asymptomatic testing model rolled out from January 2021, using DHSC 3T/7T LFD tests. Distribution to healthcare settings from July 2021.
February to April 2021	DHSC provides fortnightly data to the MHRA, in line with the EUA conditions.
May to August 2021	DHSC adopts a formal format for periodic summary reporting of PMS data (PSR-001), and continues to supply fortnightly reports to the MHRA.
1 October 2021	UKHSA becomes operational.
October 2021	UKHSA recruits a post market surveillance subject matter expert to support with improving reporting parameters of the periodic summary report.
December 2021	UKHSA implements a literature review process, improves reporting parameters and increases scope of the periodic summary report. UKHSA implements and updated trending methodology.
August 2021 to July 2022	UKHSA agrees with the MHRA to supply periodic summary reports on a monthly basis. The last monthly report is submitted to the MHRA 15 July 2022 (PSR-019).
April 2022	Due to a change in government policy on testing in February 2022 there was a significant reduction in distributed LFD kits. UKHSA and MHRA agree to reduce reporting cadence to quarterly from July 2022 onwards.
September 2022	First quarterly periodic summary report submitted to MHRA as agreed (PSR-020).
September 2022 to September 2023	UKHSA submits quarterly periodic summary reports to MHRA.
30 June 2023	Exceptional use authorization expires, and UKHSA no longer distribute this product.
3 August 2023	MHRA issue formal notification to DHSC and UKHSA that the EUA is no longer valid.
October 2023	MRHA and UKHSA agree that PSR-024, submitted 13 October 2023, will be the last quarterly submission. One final submission will cover the final 8 month period until the product expires.
22 March 2024	DHSC submit a final periodic summary report (PSR), covering the reporting period 1 October 2023 to 8 March 2024.