Request for Information – Medical Device Quality Control (QC) Testing Capacity

The purpose of this document is to enhance the Authority’s understanding of the marketplace and its options for sourcing for a potential future requirement. 2. The issuance of this request for information (RFI) does not constitute a sourcing exercise nor will the Authority pay any costs incurred in the preparation of a response to this RFI. 3.

The UK Health Security Agency’s (UKHSA) key objectives for this RFI are: a. understand the ability of the marketplace to fulfil its requirements. b. refine the scope of the requirements to best align to the marketplace; and c. inform the Authority’s chosen route to market to best enable competition 4. The key dates for this RFI are as follows: 1.

RFI Published: 27th April 2026 2. RFI Response: 17:00 - 29th May 2026 5.

Should you have any questions or queries relating to this RFI, please use the Atamis portal’s messaging centre to direct your questions to us for a response. 6. If a response is not received by the RFI response deadline this will have no impact on your ability to tender for the opportunity in the future.

UKHSA will not enter into contracts on the basis of replies to this RFI.   | Description of Scope of Requirements: The UK Health Security Agency (UKHSA) is responsible for protecting the public from infectious diseases, chemical, biological, radiological and nuclear hazards, and other health threats. We provide scientific, operational and strategic leadership nationally, locally, and internationally to strengthen the nation’s health security.

UKHSA is assessing opportunities to enhance its existing Quality Control (QC) testing capability through collaboration with UK-based organisations that deliver operational QC services for medical devices and related products (primarily, LFD & PCR testing kits). This Request for Information (RFI) aims to understand the capability, capacity, readiness, and interest of organisations that may be able to support UKHSA’s public health mission during surge periods or emergencies.

Objectives: • Identify operational QC testing facilities with available capacity or surge capability. • Assess technical, digital, and governance capabilities for potential collaboration. • Explore commercial models for engagement with UKHSA. This RFI is intended for organisations currently providing QC testing services for medical and related devices within the UK.

Responses should describe existing facilities and capabilities that could be deployed to support UKHSA’s laboratory operations, particularly during periods of increased demand or public health emergencies. These QC tests relating to Parts 1–2 of the inspection process are to be undertaken at the manufacturing facility.

Part 3 testing the performance/functionality of the kits can be undertaken either at the manufacturing site or another mutually agreed appropriate site. Recent procurements of PCR and LFD products have been from manufacturers based in the United Kingdom, United States of America, China, and Italy. Should you wish to respond to this Request for Information, please complete the response questionnaire which is found at the following link: https://atamis-1928.my.salesforce-sites.com/ProSpend__CS_...