Planning

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

NHS BLOOD AND TRANSPLANT

This public procurement record has 1 release in its history.

Planning

05 Mar 2025 at 11:15

Summary of the contracting process

NHS Blood and Transplant (NHSBT) is in the planning stage for engaging an EU Notified Body designated under Regulation (EU) 2017/746 (IVDR) to undertake conformity assessment and surveillance of in vitro diagnostic medical devices (IVDs). The buyer, NHSBT, is a Special Health Authority providing blood and transplant services within the UK, with its main office located in Bristol. Suppliers interested in participating must express their interest by 14th March 2025 and may be invited to a supplier meeting on 19th March 2025. This procurement falls under the services category, with a gross value of £168,000 and is set to cover a period from 19th May 2025 to 18th May 2029.

This tender presents significant opportunities for businesses specialised in conformity assessment and CE-certification of medical devices, particularly those with experience in in vitro diagnostics. Companies with robust quality assurance systems and technical inspection services should find this tender particularly appealing. Engaging in this process can help businesses establish or strengthen their footprint in the healthcare sector, providing valuable experience and potential long-term partnerships within the NHS.

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Notice Title

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

Notice Description

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 require the services of an EU Notified Body for conformity assessment and CE-certification of IVDs under the IVDR, and for appropriate surveillance of legacy IVDs.

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.

Publication & Lifecycle

Open Contracting ID
ocds-h6vhtk-04e9b3
Publication Source
Find A Tender Service
Latest Notice
https://www.find-tender.service.gov.uk/Notice/008003-2025
Current Stage
Planning
All Stages
Planning

Procurement Classification

Notice Type
UK2 - Preliminary Market Engagement Notice
Procurement Type
Standard
Procurement Category
Services
Procurement Method
Not Specified
Procurement Method Details
Not specified
Tender Suitability
Not specified
Awardee Scale
Not specified

Common Procurement Vocabulary (CPV)

CPV Divisions

71 - Architectural, construction, engineering and inspection services

72 - IT services: consulting, software development, Internet and support


CPV Codes

71630000 - Technical inspection and testing services

72225000 - System quality assurance assessment and review services

Notice Value(s)

Tender Value
£140,000 £100K-£500K
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
5 Mar 202511 months ago
Submission Deadline
Not specified
Future Notice Date
24 Mar 2025Expired
Award Date
Not specified
Contract Period
18 May 2025 - 18 May 2029 4-5 years
Recurrence
Not specified

Notice Status

Tender Status
Planning
Lots Status
Planning
Awards Status
Not Specified
Contracts Status
Not Specified

Contracting Authority (Buyer)

Main Buyer
NHS BLOOD AND TRANSPLANT
Contact Name
Rowena Thomas
Contact Email
rowena.thomas@nhsbt.nhs.uk
Contact Phone
07553 520488

Buyer Location

Locality
BRISTOL
Postcode
BS34 7QH
Post Town
Bristol
Country
England

Major Region (ITL 1)
TLK South West (England)
Basic Region (ITL 2)
TLK5 West of England
Small Region (ITL 3)
TLK52 Bath & North East Somerset and South Gloucestershire
Delivery Location
Not specified

Local Authority
South Gloucestershire
Electoral Ward
Filton
Westminster Constituency
Filton and Bradley Stoke

Further Information

Notice Documents

Open Contracting Data Standard (OCDS)

View full OCDS Record for this contracting process

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The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts.

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