Medicines and Healthcare products Regulatory Agency
UK Approved Body for In Vitro Diagnostic (IVD) Devices
This is a contract result notice, not an open opportunity. Details from the official award data.
This is a large award for Business Services — above three-quarters of comparable contracts. Based on 57,319 valued Business Services tenders in our corpus.
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).
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.
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.
What the supplier must deliver
Due to the changes, SR&I must appoint
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.
This appointment will allow SR&I to continue
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.
Derived from the notice text — always confirm against the original documents.
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- contract · Contract
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Contains public sector information licensed under the Open Government Licence v3.0. Source data © Crown copyright.
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