UK Approved Body for In Vitro Diagnostic (IVD) Devices

Concepts

• certification services
• medical devices regulations
• ivd devices
• other diagnostic laboratories
• medical devices
• eu notified body
• ivd
• vitro diagnostic
• medical devices regulations 2002
• uk approved body

Location

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.

CPV Codes

• 79132000 - Certification services

Other Information

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