Tender

UK Approved Body for In Vitro Diagnostic (IVD) Devices

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

This public procurement record has 2 releases in its history.

Tender

28 Nov 2023 at 10:18

Tender Notice
Tender

28 Nov 2023 at 10:17

Tender Notice
Summary of the contracting process

The Medicines and Healthcare products Regulatory Agency is seeking a UK Approved Body for In Vitro Diagnostic (IVD) Devices. This procurement falls under the 'Certification services' category with a total contract value of GBP 500,000. The tender is an open procedure and interested suppliers must register and apply via the Atamis e-sourcing portal. The tender deadline is set for January 10, 2024, with the contract period starting from February 1, 2024, to January 31, 2027.

This tender offers an opportunity for businesses involved in certification services for medical devices. Suppliers capable of providing certification for Annex II List A and B IVD devices are well-suited to compete. The contract location is in the South East region of the United Kingdom, with a specific postal code provided. Companies aiming to support NHS and other diagnostic laboratories in safeguarding patients' health through certification services should consider participating in this procurement process.

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Notice Information

Notice Title

UK Approved Body for In Vitro Diagnostic (IVD) Devices

Notice 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. Additional 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

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-b5fd17-f4a4e8a5-a6fa-4c07-bdef-220cb4cfe80c
Publication Source
Contracts Finder
Latest Notice
https://www.contractsfinder.service.gov.uk/Notice/13719a3b-a3cf-4af3-a207-1203938ef5e0
Current Stage
Tender
All Stages
Tender

Procurement Classification

Notice Type
Tender Notice
Procurement Type
Standard
Procurement Category
Services
Procurement Method
Open
Procurement Method Details
Open procedure (above threshold)
Tender Suitability
Not specified
Awardee Scale
Not specified

Common Procurement Vocabulary (CPV)

CPV Divisions

79 - Business services: law, marketing, consulting, recruitment, printing and security

CPV Codes

79132000 - Certification services

Notice Value(s)

Tender Value
£500,000 £500K-£1M
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
28 Nov 20232 years ago
Submission Deadline
10 Jan 2024Expired
Future Notice Date
Not specified
Award Date
Not specified
Contract Period
1 Feb 2024 - 31 Jan 2027 3-4 years
Recurrence
Not specified

Notice Status

Tender Status
Active
Lots Status
Not Specified
Awards Status
Not Specified
Contracts Status
Not Specified

Buyer & Supplier

Contracting Authority (Buyer)

Main Buyer
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
Contact Name
Available with D3 Tenders Premium →
Contact Email
Available with D3 Tenders Premium →
Contact Phone
Available with D3 Tenders Premium →

Buyer Location

Locality
LONDON
Postcode
E14 4PU
Post Town
East London
Country
England
Major Region (ITL 1)
TLI London
Basic Region (ITL 2)
TLI4 Inner London - East
Small Region (ITL 3)
TLI42 Tower Hamlets
Delivery Location
TLJ South East (England)
Local Authority
Tower Hamlets
Electoral Ward
Canary Wharf
Westminster Constituency
Poplar and Limehouse

Further Information

Notice Documents

Open Contracting Data Standard (OCDS)

View full OCDS Record for this contracting process

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The Open Contracting Data Standard (OCDS) is a framework designed to increase transparency and access to public procurement data in the public sector. It is widely used by governments and organisations worldwide to report on procurement processes and contracts. 

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