Closed
UK Approved Body for In Vitro Diagnostic (IVD) Devices
MHRA/ NIBSC · £500,000 · closes 10 Jan 2024
£500,000
Estimated value
Closed
Deadline
27 Nov 2023
Published
This tender has closed.
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About this contract
The Medicines and Healthcare products Regulatory Agency requires a UK Approved Body that is capable of certifying IVD devices produced by Scientific Research and Innovation that are placed on the GB market.
Key dates
Published27 Nov 2023
Submission deadline10 Jan 2024 Add to calendar ↓
Source
Source notice on Find a TenderView ↗
Lot — bid on it if it fits
This contract has one lot. Bid if it suits your firm.
Scientific Research and Innovation (SR&I) (previously known as NIBSC) is placing In Vitro Diagnostic (IVD) devices on the GB market under EU IVD Directive 98/79/EC using EU Notified Body that issues CE certificates that are currently recognised on the GB market. Since 1 January 2021, there have been a number of changes to Medical Devices Regulations 2002, introduced through secondary legislation - Amendment of the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019, to how medical devices, including IVD devices, are placed on the market in Great Britain (England, Wales and Scotland).<br/>Due to the changes, SR&I must appoint a UK Approved Body that can certify all Annex II List A and B IVD devices produced by SR&I that are placed on the GB market. <br/>This appointment will allow SR&I to continue placing IVD devices on the GB market after transition deadlines and support NHS and NHSBT laboratories and other diagnostic laboratories in safeguarding patients’ health and wellbeing.Value not published
Who to contact
NameAlison Finn
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