--- title: "UK Approved Body for In Vitro Diagnostic (IVD) Devices" ocid: "ocds-b5fd17-f4a4e8a5-a6fa-4c07-bdef-220cb4cfe80c" canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-f4a4e8a5-a6fa-4c07-bdef-220cb4cfe80c" markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-f4a4e8a5-a6fa-4c07-bdef-220cb4cfe80c.md" json_url: "https://d3tenders.com/contract/ocds-b5fd17-f4a4e8a5-a6fa-4c07-bdef-220cb4cfe80c.json" source: "Contracts Finder" current_stage: "Tender" buyer: "MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY" published: "2023-11-28" --- # UK Approved Body for In Vitro Diagnostic (IVD) Devices Buyer: MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY Current stage: Tender OCID: ocds-b5fd17-f4a4e8a5-a6fa-4c07-bdef-220cb4cfe80c [View canonical contract page](https://d3tenders.com/contract/?ocid=ocds-b5fd17-f4a4e8a5-a6fa-4c07-bdef-220cb4cfe80c) [Download OCDS JSON](https://d3tenders.com/contract/ocds-b5fd17-f4a4e8a5-a6fa-4c07-bdef-220cb4cfe80c.json) ## Summary The Medicines and Healthcare products Regulatory Agency is seeking a UK Approved Body for In Vitro Diagnostic (IVD) Devices. This procurement falls under the 'Certification services' category with a total contract value of GBP 500,000. The tender is an open procedure and interested suppliers must register and apply via the Atamis e-sourcing portal. The tender deadline is set for January 10, 2024, with the contract period starting from February 1, 2024, to January 31, 2027. This tender offers an opportunity for businesses involved in certification services for medical devices. Suppliers capable of providing certification for Annex II List A and B IVD devices are well-suited to compete. The contract location is in the South East region of the United Kingdom, with a specific postal code provided. Companies aiming to support NHS and other diagnostic laboratories in safeguarding patients' health through certification services should consider participating in this procurement process. ## Notice Scientific Research and Innovation (SR&I) (previously known as NIBSC) is placing In Vitro Diagnostic (IVD) devices on the GB market under EU IVD Directive 98/79/EC using EU Notified Body that issues CE certificates that are currently recognised on the GB market. Since 1 January 2021, there have been a number of changes to Medical Devices Regulations 2002, introduced through secondary legislation - Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, to how medical devices, including IVD devices, are placed on the market in Great Britain (England, Wales and Scotland). Due to the changes, SR&I must appoint a UK Approved Body that can certify all Annex II List A and B IVD devices produced by SR&I that are placed on the GB market. This appointment will allow SR&I to continue placing IVD devices on the GB market after transition deadlines and support NHS and NHSBT laboratories and other diagnostic laboratories in safeguarding patients' health and wellbeing. Additional information: To express interest and participate in the tender, please register and apply via Atamis e-sourcing portal https://health-family.force.com/s/Welcome. Should Tenderers have any queries, or having problems using the portal, they should contact Helpdesk at: Phone: 0800 9956035 E-mail: support-health@atamis.co.uk ## Key Details | Field | Value | | --- | --- | | Publication source | Contracts Finder | | Latest notice | https://www.contractsfinder.service.gov.uk/Notice/13719a3b-a3cf-4af3-a207-1203938ef5e0 | | Notice type | Tender Notice | | Procurement type | Standard | | Procurement category | Services | | Procurement method | Open | | Procurement method details | Open procedure (above threshold) | | Tender suitability | Not specified | | Awardee scale | Not specified | | All stages | Tender | ## Dates | Field | Value | | --- | --- | | Publication date | 28 Nov 2023 | | Submission deadline | 10 Jan 2024 | | Future notice date | Not specified | | Award date | Not specified | | Contract period | 1 Feb 2024 - 31 Jan 2027 | | Recurrence | Not specified | ## Values | Field | Value | | --- | --- | | Tender value | £500,000 | | Lots value | Not specified | | Awards value | Not specified | | Contracts value | Not specified | ## Status | Field | Value | | --- | --- | | Tender status | Active | | Lots status | Not specified | | Awards status | Not specified | | Contracts status | Not specified | ## Buyer | Field | Value | | --- | --- | | Main buyer | MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY | | Locality | LONDON | | Post town | East London | | Postcode | E14 4PU | | Country | England | | ITL 1 | TLI London | | ITL 2 | TLI4 Inner London - East | | ITL 3 | TLI42 Tower Hamlets | | Local authority | Tower Hamlets | | Electoral ward | Canary Wharf | | Westminster constituency | Poplar and Limehouse | | Delivery location | TLJ South East (England) | ## CPV Codes ### Divisions - 79 - Business services: law, marketing, consulting, recruitment, printing and security ### Codes - 79132000 - Certification services ## Release History - 28 Nov 2023 at 10:18 - Tender - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/13719a3b-a3cf-4af3-a207-1203938ef5e0 - 28 Nov 2023 at 10:17 - Tender - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/29e355f3-2015-4d96-8174-42ffd42a2b77 ## Documents - https://www.contractsfinder.service.gov.uk/Notice/13719a3b-a3cf-4af3-a207-1203938ef5e0 28th November 2023 - Opportunity notice on Contracts Finder - https://www.contractsfinder.service.gov.uk/Notice/29e355f3-2015-4d96-8174-42ffd42a2b77 28th November 2023 - Opportunity notice on Contracts Finder ## Notice URLs - https://health-family.force.com/s/Welcome ## 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-f4a4e8a5-a6fa-4c07-bdef-220cb4cfe80c. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-b5fd17-f4a4e8a5-a6fa-4c07-bdef-220cb4cfe80c.json.