---
title: "UK Approved Body for In Vitro Diagnostic (IVD) Devices"
ocid: "ocds-h6vhtk-041d1b"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-041d1b"
markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-041d1b.md"
json_url: "https://d3tenders.com/contract/ocds-h6vhtk-041d1b.json"
source: "Find A Tender Service"
current_stage: "Tender"
buyer: "MHRA/ NIBSC"
published: "2023-11-27"
---

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

Buyer: MHRA/ NIBSC  
Current stage: Tender  
OCID: ocds-h6vhtk-041d1b

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[Download OCDS JSON](https://d3tenders.com/contract/ocds-h6vhtk-041d1b.json)

## Summary

The Medicines and Healthcare products Regulatory Agency is seeking a UK Approved Body for certifying In Vitro Diagnostic (IVD) Devices in the GB market. The tender, titled "UK Approved Body for In Vitro Diagnostic (IVD) Devices", falls under the services category with a value of £500,000. The procurement stage is currently active, with a contract period starting from February 1, 2024, to January 31, 2027. The tender deadline for submissions is January 10, 2024.

This opportunity to certify IVD devices can benefit companies specializing in medical device certification and testing services. The tender requires UK approved bodies to comply with the Medical Devices Regulations 2002. Businesses in the healthcare and certification services industry may find this tender suitable for enhancing their market presence and contributing to patient safety in the healthcare sector.

## Notice

The Medicines and Healthcare products Regulatory Agency requires a UK Approved Body that is capable of certifying IVD devices produced by Scientific Research and Innovation that are placed on the GB market.

### Lot Information

Lot 1

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.

Renewal: two optional one-year extensions

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Find A Tender Service |
| Latest notice | https://www.find-tender.service.gov.uk/Notice/034981-2023 |
| Notice type | Tender Notice |
| Procurement type | Standard |
| Procurement category | Services |
| Procurement method | Open |
| Procurement method details | Open procedure |
| Tender suitability | Not specified |
| Awardee scale | Not specified |
| All stages | Tender |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 27 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 | Active |
| Awards status | Not specified |
| Contracts status | Not specified |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | MHRA/ NIBSC |
| Locality | LONDON |
| Post town | Enfield |
| Postcode | EN6 3QG |
| Country | England |
| ITL 1 | TLH East (England) |
| ITL 2 | TLH2 Bedfordshire and Hertfordshire |
| ITL 3 | TLH27 South West Hertfordshire |
| Local authority | Hertsmere |
| Electoral ward | Shenley |
| Westminster constituency | Hertsmere |
| Delivery location | Not specified |

## CPV Codes

### Divisions

- 79 - Business services: law, marketing, consulting, recruitment, printing and security

### Codes

- 79132000 - Certification services

## Release History

- 27 Nov 2023 at 17:18 - Tender - Tender Notice - https://www.find-tender.service.gov.uk/Notice/034981-2023

## Notice URLs

- https://health-family.force.com/s/Welcome
- https://www.gov.uk/government/organisations/department-of-health-and-social-care
- https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency

## 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-h6vhtk-041d1b. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-041d1b.json.