# UK Approved Body for In Vitro Diagnostic \(IVD\) Devices

> Tender notice from UK public-sector procurement sources.

## Key facts

- Public buyer: [Medicines and Healthcare products Regulatory Agency](/buyers/medicines-and-healthcare-products-regulatory-agency/contract-awards)
- Tender value: £500,000
- Published: 28 November 2023
- Planned start: 1 February 2024
- Planned end: 31 January 2027
- Stage: open_tender
- Procurement category: services
- Notice ID: 29e355f3-2015-4d96-8174-42ffd42a2b77-702168
- OCID: ocds-b5fd17-f4a4e8a5-a6fa-4c07-bdef-220cb4cfe80c

## Description

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

## Related contract awards

- [Enterprise Digital Organisation Design and Change Programme](/contracts/ocds-b5fd17-9633d978-550d-4e81-a000-d15284b61679): Medicines and Healthcare Products Regulatory Agency
- [Patient Information Project Support - centralised leaflets source](/contracts/ocds-b5fd17-16187b24-a5b6-43d2-9895-0c16cd637f09): Medicines and Healthcare Products Regulatory Agency
- [C468225 - Topographical and Tree Survey](/contracts/ocds-b5fd17-a318314e-edf8-4790-8897-cefab2fe8b4f): Medicines and Healthcare Products Regulatory Agency

## Source

[View the original notice on Contracts Finder](https://www.contractsfinder.service.gov.uk/Notice/29e355f3-2015-4d96-8174-42ffd42a2b77-702168)