UK Approved Body for In Vitro Diagnostic (IVD) Devices
Details
- Buyer
- The National Institute for Biological Standards and Control (NIBSC), Medicines and Healthcare products Regulatory Agency
- Value
- £500,000
- Topic
- Certification services
- Published
- 27 November 2023
- Submission
- 10 January 2024
- Source
- uk:find_a_tender
Tender description
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. Lot 1: 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.
Timeline
- Completed: Tender published27 November 2023Current notice
- Completed: Submission date10 January 2024
About the buyer
The National Institute for Biological Standards and Control (NIBSC) is a public sector buyer in the United Kingdom publishing tenders and awards on Stotles. Explore their procurement activity and find more opportunities like this one.
Decision makers
Connect with the people behind this procurement.
| Contact name | Job title | Phone number | Work email |
|---|---|---|---|
| Head of Procurement | +44 •••• •••••• | ••••••••@the-national-institute-for-biological-standards-and-control-nibsc.gov | |
| Commercial Director | +44 •••• •••••• | ••••••••@the-national-institute-for-biological-standards-and-control-nibsc.gov | |
| Procurement Manager | +44 •••• •••••• | ••••••••@the-national-institute-for-biological-standards-and-control-nibsc.gov | |
| Category Lead | +44 •••• •••••• | ••••••••@the-national-institute-for-biological-standards-and-control-nibsc.gov | |
| Senior Buyer | +44 •••• •••••• | ••••••••@the-national-institute-for-biological-standards-and-control-nibsc.gov | |
| Contracts Manager | +44 •••• •••••• | ••••••••@the-national-institute-for-biological-standards-and-control-nibsc.gov |
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