Published date: 28 November 2023
This notice was replaced on 28 November 2023
This notice does not contain the most up-to-date information about this procurement. The most recent notice is:
Opportunity (published 28 November 2023, last edited 28 November 2023)
Closed opportunity - This means that the contract is currently closed. The buying department may be considering suppliers that have already applied, or no suitable offers were made.
Contract summary
Industry
Certification services - 79132000
Location of contract
EN6 3QG
Value of contract
£500,000
Procurement reference
CF-2037500D0O000000rwimUAA
Published date
28 November 2023
Closing date
10 January 2024
Closing time
12pm
Contract start date
1 February 2024
Contract end date
31 January 2027
Contract type
Service contract
Procedure type
Open procedure (above threshold)
Any interested supplier may submit a tender in response to an opportunity notice.
This procedure can be used for procurements above the relevant contract value threshold.
Contract is suitable for SMEs?
No
Contract is suitable for VCSEs?
No
Description
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.
More information
Additional text
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To express interest and participate in the tender, please register and apply via Atamis e-sourcing portal https://health-family.force.com/s/Welcome.
Should Tenderers have any queries, or having problems using the portal, they should contact Helpdesk at:
Phone: 0800 9956035
E-mail: support-health@atamis.co.uk
About the buyer
Contact name
Alison Finn
Address
Medicines & Healthcare products Regulatory Agency
London
E14 4PU
GB
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