Source: https://tendernation.io/opportunities/01a13cd1-530a-72bd-a6af-6e5736cc6e43/uk-approved-body-for-in-vitro-diagnostic-ivd-devices

closed GB open procedure

# UK Approved Body for In Vitro Diagnostic (IVD) Devices

[Medicines and Healthcare products Regulatory Agency](https://tendernation.io/buyers/medicines-and-healthcare-products-regulatory-agency)

Estimated value

£500,000

Published

28 Nov 2023

Deadline

Closed

10 Jan 2024

## Who can bid

- Open procedure

    Anyone can submit a full tender; there is no shortlisting stage.

## About this tender

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.

Additional information:

To express interest and participate in the tender, please register and apply via Atamis e-sourcing portal [health-family.force.com/s/Welcome](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: 

## CPV classification

Certification services

Source

Contracts Finder (UK)

[View official notice](https://www.contractsfinder.service.gov.uk/notice/f4a4e8a5-a6fa-4c07-bdef-220cb4cfe80c)

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