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Published 05 Mar 2025

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

NHS Blood and Transplant · United Kingdom

Key facts

Estimated value
£140,000
Engagement closes
14 Mar 2025
Contract ends
18 May 2029
Buyer type
Health

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.

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