--- title: "Request for Information - Regulatory and Quality Managed Service for UKHSA Covid" ocid: "ocds-b5fd17-fe75940b-7c3f-43f5-9633-8c340597e541" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-fe75940b-7c3f-43f5-9633-8c340597e541" markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-fe75940b-7c3f-43f5-9633-8c340597e541.md" json_url: "https://d3tenders.com/contract/ocds-b5fd17-fe75940b-7c3f-43f5-9633-8c340597e541.json" source: "Contracts Finder" current_stage: "Planning" buyer: "UK HEALTH SECURITY AGENCY" published: "2022-09-30" --- # Request for Information - Regulatory and Quality Managed Service for UKHSA Covid Buyer: UK HEALTH SECURITY AGENCY Current stage: Planning OCID: ocds-b5fd17-fe75940b-7c3f-43f5-9633-8c340597e541 [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-b5fd17-fe75940b-7c3f-43f5-9633-8c340597e541) [Download OCDS JSON](https://d3tenders.com/contract/ocds-b5fd17-fe75940b-7c3f-43f5-9633-8c340597e541.json) ## Summary The UK Health Security Agency is seeking to procure a Regulatory and Quality Managed Service for Covid-19 related devices. The procurement process is in the planning stage, with an engagement end date set for 11th October 2022. The service is classified under business and management consultancy services and is located at Noble House, 17 Smith Square, London, SW1P 3HX. This tender presents an opportunity for businesses specialising in regulatory compliance and quality management services to compete. The UK Health Security Agency, based in London, is the buyer organisation for this tender. The procurement method is a Request for Information, targeting small and medium-sized enterprises (SMEs) and voluntary, community, and social enterprise organisations (VCSEs). Businesses interested in providing Regulatory and Quality support for Covid-19 devices until 31st March 2024 are well-suited to participate. The geographical scope of delivery includes the United Kingdom, British Oversea Territories, Channel Islands, Europe, Isle of Man, and the rest of the world. ## Notice The UK Health Security Agency (UKHSA) is responsible for protecting every member of every community from the impact of infectious diseases, chemical, biological, radiological and nuclear incidents and other health threats. We provide intellectual, scientific and operational leadership at national and local level, as well as on the global stage, to make the nation's health secure. The Diagnostics and Innovation team has a remit across the United Kingdom to provide Regulatory and Quality support for Covid-19 lateral Flow devices, PCR specimen collection and antiviral kits and related software devices. This is applicable where UKHSA is the legal manufacture of devices or has a significant role in procuring, developing and or distributing Covid-19 medical and IVD devices The Diagnostics and Innovation unit requires an integrated managed service to meet the Regulatory (MDR 2002 SI618) and MHRA requirements for these devices until no longer required which is anticipated to be 31st March 2024. Should you wish to respond to this Request for Information, please complete and return the response questionnaire via the messaging section on the following eTendering portal which is found at the following link: https://health-family-contract-search.secure.force.com/ProSpend__CS_ContractPage?SearchType=Projects&uid=a078d000000vng8AAA&searchStr=&sortStr=Recently+Published&page=1&filters=&County= ## Key Details | Field | Value | | --- | --- | | Publication source | Contracts Finder | | Latest notice | https://www.contractsfinder.service.gov.uk/Notice/2e5adbbd-fa74-4cdf-9f8b-214035fce2f9 | | Notice type | Market Engagement Notice | | Procurement type | Standard | | Procurement category | Services | | Procurement method | Not Specified | | Procurement method details | Not specified | | Tender suitability | SME, VCSE | | Awardee scale | Not specified | | All stages | Planning | ## Dates | Field | Value | | --- | --- | | Publication date | 30 Sep 2022 | | Submission deadline | Not specified | | Future notice date | 11 Oct 2022 | | Award date | Not specified | | Contract period | Not specified | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | Not specified | | Lots value | Not specified | | Awards value | Not specified | | Contracts value | Not specified | ## Status | Field | Value | | --- | --- | | Tender status | Planning | | Lots status | Not specified | | Awards status | Not specified | | Contracts status | Not specified | ## Buyer | Field | Value | | --- | --- | | Main buyer | UK HEALTH SECURITY AGENCY | | Locality | LONDON | | Post town | South West London | | Postcode | SW1P 3HX | | Country | England | | ITL 1 | TLI London | | ITL 2 | TLI3 Inner London - West | | ITL 3 | TLI35 Westminster and City of London | | Local authority | Westminster | | Electoral ward | St James's | | Westminster constituency | Cities of London and Westminster | | Delivery location | Not specified | ## CPV Codes ### Divisions - 79 - Business services: law, marketing, consulting, recruitment, printing and security ### Codes - 79410000 - Business and management consultancy services ## Release History - 30 Sep 2022 at 11:59 - Planning - Market Engagement Notice - https://www.contractsfinder.service.gov.uk/Notice/2e5adbbd-fa74-4cdf-9f8b-214035fce2f9 ## Documents - https://www.contractsfinder.service.gov.uk/Notice/2e5adbbd-fa74-4cdf-9f8b-214035fce2f9 30th September 2022 - Early engagement notice on Contracts Finder ## Notice URLs - https://health-family-contract-search.secure.force.com/ProSpend__CS_ContractPage?SearchType=Projects&uid=a078d000000vng8AAA&searchStr=&sortStr=Recently+Published&page=1&filters=&County= ## Provenance This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-b5fd17-fe75940b-7c3f-43f5-9633-8c340597e541. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-b5fd17-fe75940b-7c3f-43f5-9633-8c340597e541.json.