Eu Notified Body Designated under Regulation (Eu) 2017/746 (Ivdr) Tender, United Kingdom - 116882051

Procurement Summary

Country : United Kingdom

Summary : Eu Notified Body Designated under Regulation (Eu) 2017/746 (Ivdr)

Deadline : 24 Apr 2025

Other Information

Notice Type : Tender

TOT Ref.No.: 116882051

Document Ref. No. :

Financier : Self Financed

Purchaser Ownership : Public

Tender Value : GBP 192000

Purchaser's Detail

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Tender Details

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'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...

Documents

 Tender Notice