UK Approved Body for In Vitro Diagnostic (IVD) Devices

Concepts

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

Location

London

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.

Total Quantity or Scope

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.

Renewal Options

two optional one-year extensions

CPV Codes

• 79132000 - Certification services

Indicators

• Bids should cover the whole contract.
• This is a recurring contract.
• Renewals are available.
• Performance considerations apply.
• Professional qualifications are sought.
• Award on basis of price and quality.