Official UK procurement notice
EU Notified Body designated under Regulation (EU) 2017/746 (IVDR)
Authority: NHS Blood and Transplant (Central government)
What is being bought
Published requirement descriptionNHS 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.
- The authority expects to re-tender this requirement around 1 Jan 2029, 23:59 GMT.
CPV: System quality assurance assessment and review services · Technical inspection and testing services
The lotProcurement structure
single lot · value publishedLot #1Lot 1AwardedRenewalPublished value£160,000
- Value
- £160,000 exc. VAT · £192,000 inc. VAT
- Extensions
- 2 x 12 monthly or cumulative extension to a maximum 4 year contract · 2 x 12 monthly or cumulative extension to a maximum 4 year contract
What it takes to wini
How this buyer will score bids.
The evaluation criteria and weights exactly as published on the notice, grouped by family (price, quality, social value and so on).
Evaluation split and conditions of participation as published — the tender pack may add morei
How this buyer will score bids.
The evaluation criteria and weights exactly as published on the notice, grouped by family (price, quality, social value and so on).
Procedure terms & legal framework
From the official record- Procedure method
- Open procedure
- Legal basis
- UKPGA · 2023/54 Procurement Act 2023
- Procurement category
- Services
- Notice status
- Cancelled
- Procurement threshold
- Above threshold (FTS publication)
- Regulatory regime
- Standard
- Commercial structure
- Stand-alone contract (no framework)
- Competition type
- Competitive procedure
- GPA / WTO covered
- Yes (GPA)
- Recurring procurement
- Yes · next expected 1 Jan 2029
- First published
- 6 May 2025, 14:57 BST
- Last source update
- 6 May 2025, 14:57 BST
- Award evaluation window
- Submission end — 6 May 2025, 23:59 BST
- Authority reference
C343711- Latest notice
- Procurement termination notice (UK12)
- Classification (CPV)
- Delivery area
- Official registry OCID
ocds-h6vhtk-04e9b4Find a Tender- Contract terms summary
- 30 day payment terms, paid monthly based on services provided
- Risks
- Due to the nature of the contract and the unknown hours of work that may be required to undertake the assessments, there is a risk that the predicted whole life costs used to calculate the potential contract value may be exceeded.
How it was run
Official notice- Submission deadline
- 24 Apr 2025, 12:00 BST
- Clarification deadline
- 16 Apr 2025, 12:00 BST
- Submission channel
- Official e-sourcing portal
- Electronic submission
- Allowed
- Accepted languages
- en
Timeline
9 published dates · Europe/London- Planning notice published5 Mar 2025, 11:15 GMT
- Market engagement14 Mar 2025, 23:59 GMT
Interested suppliers are asked to express their interest to [email protected] and [email protected] 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 more…
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. - Next notice expected24 Mar 2025, 23:59 GMT
- Tender notice published27 Mar 2025, 16:58 GMT
- Clarification questions by16 Apr 2025, 12:00 BST
- Submission deadline24 Apr 2025, 12:00 BST
- Latest notice published6 May 2025, 14:57 BST
- Award decision expected by6 May 2025, 23:59 BST
- Contract starts26 May 2025, 00:00 BST
Commercial outcome & contract awards
Published awards, contracts and bid statistics — not a forecast| Awarded to | Value | Date | Status |
|---|---|---|---|
| supplier not published | — | 2 May 2025 | CancelledNo bids received |
Notice history
12 events · 3 releases on Find a Tender · since 5 Mar 2025- Procurement termination notice published6 May 2025, 14:57 BSTUK12
- Published value updated6 May 2025, 14:57 BSTwas £160,000
- Status changed to complete6 May 2025, 14:57 BST
- Procurement method changed6 May 2025, 14:57 BST
- Deadline withdrawn6 May 2025, 14:57 BST
- Buyer details updated6 May 2025, 14:57 BST
- Tender notice published27 Mar 2025, 16:58 GMTUK4
- Published value updated to £160,00027 Mar 2025, 16:58 GMTwas £140,000
- Status changed to active27 Mar 2025, 16:58 GMT
- Procurement method changed27 Mar 2025, 16:58 GMT
- Deadline published: 24 Apr 2025, 12:00 BST27 Mar 2025, 16:58 GMT
- Preliminary market engagement notice published5 Mar 2025, 11:15 GMTUK2
Contracting authority & participating public bodies
Official documents & specifications (4)
Official links; attachments are not copiedTender pack and attachments
- Conflict of interest declarationNot published
Notices published for this procedure
- Procurement termination notice Procurement termination notice on Find a Tender
- Tender notice Tender notice on Find a Tender
- Preliminary market engagement notice Preliminary market engagement notice on Find a Tender