Award

Notified body and ISO13485:2016 certification body

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

This public procurement record has 2 releases in its history.

Award

30 Nov 2018 at 14:49

Tender

04 Jun 2018 at 13:17

Summary of the contracting process

The Medicines and Healthcare Products Regulatory Agency (MHRA) is seeking to appoint a Notified Body and ISO 13485:2016 certification body for its National Institute for Biological Standards and Control (NIBSC) facility, located in Potters Bar, Hertfordshire, England. This tender was published on 4th June 2018, with a bidding period that closed on 3rd July 2018. The procurement method is classified as an open procedure, aimed at delivering calibration and industrial inspection services relevant to the healthcare sector, with contract execution scheduled to commence on 1st August 2018 and continue until 31st July 2021.

This tender presents significant opportunities for businesses specialising in calibration, auditing, and quality assurance services within the healthcare sector. Companies capable of delivering industrial inspection services and those experienced in environmental quality control will find this procurement particularly relevant. Given the MHRA's commitment to enhancing public health standards, successful bidders may benefit from ongoing collaborations and increased visibility in the healthcare market.

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Notice Title

Notified body and ISO13485:2016 certification body

Notice Description

The Medicines and Healthcare products Regulatory Agency is preparing to tender for a new Notified Body and ISO 13485 certificating body for one of its centre "National Institute for Biological Standards and Control (NIBSC)". NIBSC is a multi-disciplinary scientific establishment whose purpose is to safeguard and enhance public health by standardising and controlling biological substances used in medicines. One of its key roles is the production of reference materials including in vitro diagnostic devices (IVDs) and we are preparing to tender for a new Notified Body and ISO 13485:2016 certification body. We currently have 45 staff that are involved in the design and manufacture of 91 IVD products of which, 44 are currently Annex II List A and List B, and 47 are currently self-certified. Additional information: If you are interested to participate in the tendering process and wants to know more about this opportunity, please visit our Bravo e-procurement portal by following the above stated web link.

Publication & Lifecycle

Open Contracting ID
ocds-b5fd17-ff24a355-273a-4bb9-8e14-5853b9518608
Publication Source
Contracts Finder
Latest Notice
https://www.contractsfinder.service.gov.uk/Notice/a245ed15-8cbc-4260-a4ce-79689f2ecd48
Current Stage
Award
All Stages
Tender, Award

Procurement Classification

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

Common Procurement Vocabulary (CPV)

CPV Divisions

50 - Repair and maintenance services

71 - Architectural, construction, engineering and inspection services

72 - IT services: consulting, software development, Internet and support

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

90 - Sewage, refuse, cleaning and environmental services


CPV Codes

50433000 - Calibration services

71730000 - Industrial inspection services

72225000 - System quality assurance assessment and review services

79212000 - Auditing services

90714500 - Environmental quality control services

Notice Value(s)

Tender Value
Not specified
Lots Value
Not specified
Awards Value
£47,000 Under £100K
Contracts Value
Not specified

Notice Dates

Publication Date
30 Nov 20187 years ago
Submission Deadline
3 Jul 2018Expired
Future Notice Date
Not specified
Award Date
6 Sep 20187 years ago
Contract Period
20 Sep 2018 - 20 Sep 2021 3-4 years
Recurrence
Not specified

Notice Status

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

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
POTTERS BAR, HERTFORDSHIRE
Postcode
EN6 3QG
Post Town
Enfield
Country
England

Major Region (ITL 1)
TLH East (England)
Basic Region (ITL 2)
TLH2 Bedfordshire and Hertfordshire
Small Region (ITL 3)
TLH27 South West Hertfordshire
Delivery Location
Not specified

Local Authority
Hertsmere
Electoral Ward
Shenley
Westminster Constituency
Hertsmere

Supplier Information

Number of Suppliers
1
Supplier Name

UL INTERNATIONAL (UK

Further Information

Notice Documents

Open Contracting Data Standard (OCDS)

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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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