FOI release

Freedom of Information request on methods we use to ‘ensure the safety and performance of medical devices’ and specifically methods employed to ensure the safety and performance of all the lateral flow tests in particular the Innova (FOI 21/1106)

Published 27 April 2022

29th October 2021 FOI 21/1106

Dear

We would like to send you an updated reply to our response of Friday 29th October.

Thank you for your follow up email dated 1st October in which you requested information on methods we use to ‘ensure the safety and performance of medical devices’ and specifically methods employed to ensure the safety and performance of all the lateral flow tests in particular the Innova lateral flow test currently in use. You have stated you would like Copies of all reports, tests, results and any other information you have that demonstrate how the safety and performance has been ensured.

For medical devices, the MHRA regulates according to the Medical Device Regulations 2002 (as amended) covering active implantable medical devices, medical devices and in vitro diagnostic medical devices. These regulations set requirements for placing medical devices on the market. Further information about how we enforce them can be found at: Medical devices regulations: compliance and enforcement - GOV.UK

To ensure that medical devices placed on the market and put into service in the UK meet these regulatory requirements we perform the following activities: · assess all allegations of non-compliance brought to us. · monitor the activity of UK Approved Bodies designated by MHRA to assess the compliance of manufacturers and their medical devices with the requirements · investigate medical devices as a result of adverse incident reportsor intelligence indicating a potential problem

These activities form part of our market surveillance obligations under Regulation 765/2008 and we undertake them in accordance with the statutory principles of the Regulators’ Code.

As indicated in earlier correspondence of 19 August with you, MHRA continues to monitor for safety issues as part of our post market surveillance activities and considers a wide range of information when assessing the safety and performance of all medical devices including rapid antigen lateral flow tests

The legal manufacturer of the device also has an obligation to gather and analyse post market surveillance data throughout the lifecycle of the device. They have legal obligations to report adverse incidents to MHRA and to take field safety corrective actions to protect the users of their device when necessary. MHRA publish alerts, recalls and safety information which can be found at: https://www.gov.uk/drug-device-alerts We also work with a a Varient of Concern Assurance group to monitor the performance of assays. Information about this work can be found at: SARS-CoV-2 variant of concern diagnostic assurance - GOV.UK

Following the roll-out of rapid testing, NHS Test and Trace has published their analysis of rapid testing using lateral flow devices (LFDs). The performance data can be found by following the links: https://www.gov.uk/government/news/oxford-university-and-phe-confirm-high-sensitivity-of-lateral-flow-tests. and lateral flow device performance data published by Department of Health and Social Care at Lateral flow device performance data - GOV.UK This data indicates the post market surveillance performance of the device and was reviewed by MHRA when published.

I hope you will find this information helpful.

Yours sincerely,

MHRA Customer Service Centre Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU