Scope
Reference
C343711
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.
Total value (estimated)
- £140,000 excluding VAT
- £168,000 including VAT
Above the relevant threshold
Contract dates (estimated)
- 19 May 2025 to 18 May 2029
- 4 years
Main procurement category
Services
CPV classifications
- 71630000 - Technical inspection and testing services
- 72225000 - System quality assurance assessment and review services
Contract locations
- UK - United Kingdom
Engagement
Engagement deadline
14 March 2025
Engagement process description
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.
Submission
Publication date of tender notice (estimated)
24 March 2025
Contracting authority
NHS Blood and Transplant
- Public Procurement Organisation Number: PDBY-6395-VWBP
500 North Bristol Park
Bristol
BS34 7QH
United Kingdom
Contact name: Rowena Thomas
Telephone: 07553 520488
Email: rowena.thomas@nhsbt.nhs.uk
Website: https://www.nhsbt.nhs.uk/
Region: UKK12 - Bath and North East Somerset, North Somerset and South Gloucestershire
Organisation type: Public authority - central government