---
title: "EU Notified Body designated under Regulation (EU) 2017/746 (IVDR)"
ocid: "ocds-h6vhtk-04e9b4"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-h6vhtk-04e9b4"
markdown_url: "https://d3tenders.com/contract/ocds-h6vhtk-04e9b4.md"
json_url: "https://d3tenders.com/contract/ocds-h6vhtk-04e9b4.json"
source: "Find A Tender Service"
current_stage: "Tender"
buyer: "NHS BLOOD AND TRANSPLANT"
published: "2025-05-06"
---

# EU Notified Body designated under Regulation (EU) 2017/746 (IVDR)

Buyer: NHS BLOOD AND TRANSPLANT  
Current stage: Tender  
OCID: ocds-h6vhtk-04e9b4

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## Summary

The procurement process initiated by NHS Blood and Transplant (NHSBT), a central government public authority in Bristol, United Kingdom, involved seeking an EU Notified Body for the conformity assessment and certification of in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746 (IVDR). This process, embedded within the services industry category, planned to transition from the legacy directive to the new regulations while ensuring continued compliance and operational standards. The procurement spanned through numerous key stages starting with planning on 5th March 2025, moving to the tender phase by 27th March 2025, with an initial closure of the tender period on 24th April 2025. Despite these efforts, the tender was ultimately cancelled on the 6th of May 2025, due to no bids being received, as previously announced in the tender cancellation notice.

This tender created substantial opportunities for businesses specialising in quality assurance and testing services, especially those with competencies in medical and healthcare device certifications. Organisations familiar with regulatory compliance and possessing the capacity to handle conformity assessment for healthcare devices would have been ideal contenders. The primary procurement method was open, indicating broad accessibility and inclusion for potential suppliers meeting the tender’s criteria. The precise structuring of the procurement, including timelines and specified contract extensions, would have appealed to SMEs capable of delivering high-value technical services with the potential for contractual extensions up to four years, hence offering considerable avenues for growth in a stable government partnership.

## Notice

NHS Blood and Transplant (NHSBT) is seeking to engage with an EU Notified Body designated under Regulation (EU) 2017/746 (IVDR) to undertake conformity assessment of in vitro diagnostic medical devices (IVDs) and appropriate surveillance of legacy IVDs. NHSBT is a Special Health Authority that provides a blood and transplantation service to the NHS, looking after blood donation services in England and transplant services across the UK. NHSBT Reagents is a specialist department within NHSBT that designs, manufactures and distributes in vitro diagnostic medical devices for transfusion and transplantation investigations including blood grouping control reagents. NHSBT's current EU Notified Body has not been designated under the IVDR and we require the services of an alternative EU Notified Body for conformity assessment and CE-certification of IVDs under the IVDR, and for appropriate surveillance of legacy IVDs (i.e. IVDs that are covered by a certificate issued by a Notified Body in accordance with Directive 98/79/EC (IVDD) and which comply with the conditions set out in Article 110 (3c) of the IVDR). It is imperative that NHSBT is able to lodge a formal application for conformity assessment and sign a written agreement with an alternative EU Notified Body in accordance with deadlines set out in the Article 110 (3c) point (e) and Article 110 (3c) point (f) of the IVDR, respectively. This will enable NHSBT to benefit from the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860. The device risk class, IVDR transitional deadlines and number of devices / products are summarised in the tender documents. The EU Notified Body's designation must cover the scope of designation applicable to the IVDs manufactured by NHSBT which is summarised as follows: * NBOG Codes that apply to legacy devices; IVD0101, IVD0102, IVD0302, MDS7210. * IVDR Codes that apply to the IVDR devices; IVR0101, IVR0102, IVR0103, IVR0104, IVR0105, IVR0106, IVS1004, IVT2006, IVT2008, IVT2009, IVT2011, IVP3001, IVP3006 (note: not all codes apply to all devices). NHSBT's requirements are summarised below: * Surveillance assessment of legacy devices during the transitional period. * Assessment of NHSBT's Quality Management System. * Undertake announced and unannounced audits. * Conformity assessment and CE-certification of NHSBT's IVDs. * Surveillance assessment of IVDR CE-certified IVDs (following initial certification). * Batch / product verification for Class D devices. * Validate the Summary of Safety and Performance for Class D and C devices. * Assess and approve (or reject) proposed/planned substantial changes to NHSBT Reagents product range, products or Quality Management System.

### Lot Information

Lot 1

Options: 2 x 12 monthly or cumulative extension to a maximum 4 year contract

Renewal: 2 x 12 monthly or cumulative extension to a maximum 4 year contract

### Planning Information

Interested suppliers are asked to express their interest to rowena.thomas@nhsbt.nhs.uk and carley.butcher@nhsbt.nhs.uk by 12:00 noon on Friday, 14th March 2025. Suppliers expressing an interest will be invited to attend an early market engagement exercise supplier meeting on Wednesday, 19th March 2025 (note: date subject to change). Prior to this session, interested suppliers will be provided with a draft specification of requirements and short questionnaire related to requirements. There is no guarantee that a formal procurement process will be launched as a result of this early market engagement exercise, nor that any contract(s) will be placed. No remuneration or compensation etc will be paid to organisations who take part in this early market engagement exercise. Suppliers should take part in this process only on the basis that they fully understand and accept this position.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Find A Tender Service |
| Latest notice | https://www.find-tender.service.gov.uk/Notice/019139-2025 |
| Notice type | UK12 - Procurement Termination 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 | Planning, Tender |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 6 May 2025 |
| Submission deadline | 24 Apr 2025 |
| Future notice date | 24 Mar 2025 |
| Award date | Not specified |
| Contract period | 25 May 2025 - 25 May 2027 |
| Recurrence | 2029-01-01 |

## Values

| Field | Value |
| --- | --- |
| Tender value | £160,000 |
| Lots value | £160,000 |
| Awards value | Not specified |
| Contracts value | Not specified |

## Status

| Field | Value |
| --- | --- |
| Tender status | Complete |
| Lots status | Complete |
| Awards status | Cancelled |
| Contracts status | Not specified |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | NHS BLOOD AND TRANSPLANT |
| Additional buyers | Missing |
| Locality | BRISTOL |
| Post town | Bristol |
| Postcode | BS34 7QH |
| Country | England |
| ITL 1 | TLK South West (England) |
| ITL 2 | TLK5 West of England |
| ITL 3 | TLK52 Bath & North East Somerset and South Gloucestershire |
| Local authority | South Gloucestershire |
| Electoral ward | Filton |
| Westminster constituency | Filton and Bradley Stoke |
| Delivery location | Not specified |

## CPV Codes

### Divisions

- 71 - Architectural, construction, engineering and inspection services
- 72 - IT services: consulting, software development, Internet and support

### Codes

- 71630000 - Technical inspection and testing services
- 72225000 - System quality assurance assessment and review services

## Release History

- 6 May 2025 at 13:57 - TenderCancellation - UK12 - Procurement Termination Notice - https://www.find-tender.service.gov.uk/Notice/019139-2025
- 27 Mar 2025 at 16:58 - Tender - UK4 - Tender Notice - https://www.find-tender.service.gov.uk/Notice/011644-2025
- 5 Mar 2025 at 11:15 - Planning - UK2 - Preliminary Market Engagement Notice - https://www.find-tender.service.gov.uk/Notice/008004-2025

## Documents

- https://www.find-tender.service.gov.uk/Notice/019139-2025
  6th May 2025 - Procurement termination notice on Find a Tender
- https://www.find-tender.service.gov.uk/Notice/011644-2025
  27th March 2025 - Tender notice on Find a Tender
- https://www.find-tender.service.gov.uk/Notice/008004-2025
  5th March 2025 - Preliminary market engagement notice on Find a Tender

## Notice URLs

- https://atamis-1928.my.site.com/s/Welcome
- https://www.legislation.gov.uk/ukpga/2023/54/contents
- https://www.nhsbt.nhs.uk/

## 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-04e9b4. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-h6vhtk-04e9b4.json.