Primary Blood Grouping

Tender description

Provision of a Primary Blood Grouping Managed Service to the Authority (NHS Blood and Transplant). The Service will be provided over two sites namely, Manchester and Filton. Lot 1: NHSBT requires a direct contractual relationship with either the manufacturer or any other economic operator for a complete end-to-end integrated Service, which must include all the necessary Equipment, Goods, Installation, maintenance, Consumables, Reagents, Software, including an inter-operability provision with NHSBT’s existing IT infrastructure, and an overall on-going support mechanism that may be required to carry out the necessary testing as stated below.<br/>All invitro diagnostic medical devices, for example, Instruments, Consumables and Reagents must be CE/UKCA marked. GB will continue to recognise CE marking under the IVDD or IVDR until 30 June 2023 and from 1 July 2023 devices placed on the GB market must be UKCA marked under the UK MDR 2002 as amended. Lot 1: NHSBT requires a direct contractual relationship with either the manufacturer or any other economic operator for a complete end-to-end integrated Service, which must include all the necessary Equipment, Goods, Installation, maintenance, Consumables, Reagents, Software, including an inter-operability provision with NHSBT’s existing IT infrastructure, and an overall on-going support mechanism that may be required to carry out the necessary testing as stated below.<br/>All invitro diagnostic medical devices, for example, Instruments, Consumables and Reagents must be CE/UKCA marked. GB will continue to recognise CE marking under the IVDD or IVDR until 30 June 2023 and from 1 July 2023 devices placed on the GB market must be UKCA marked under the UK MDR 2002 as amended.