Eu Notified Body Designated under Regulation (Eu) ...

FREE TRIAL

Get Access to 1 Million Global Tenders

You are Successfully Registered to zimbabwetenders!!

Email Id is already exist !!

Something went wrong !!

Publish Tenders

Click here to publish tender and gain more visibility worldwide.

Subscription Plans

Click here to upgrade to a Premium Plan.

100% Secure Payments

Tender Details

Download Tender Documents

Country: United Kingdom
Summary: Eu Notified Body Designated under Regulation (Eu) 2017/746 (Ivdr)
GBT Ref No: 116882051
Deadline: 24 Apr 2025
Competition: ICB
Financier: Self Financed
Purchaser Ownership: Public
Tender Value: 192000
Notice Type: Tender
Document Ref. No.:
Purchaser's Detail :

Purchaser : NHS BLOOD AND TRANSPLANT
500 North Bristol Park Bristol BS34 7QH United Kingdom
Email :rowena.thomas@nhsbt.nhs.uk

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'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 :