Planning

Notified Body and ISO 13485 certificating body

MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY

This public procurement record has 2 releases in its history.

Planning

24 Apr 2018 at 10:30

Planning

15 Mar 2018 at 17:08

Summary of the contracting process

The Medicines and Healthcare Products Regulatory Agency (MHRA) is initiating a tender for a new Notified Body and ISO 13485:2016 certification body as part of its efforts to enhance public health through the standardisation and control of biological substances. The procurement, classified under system quality assurance assessment and review services (CPV code: 72225000), is currently in the planning stage. The tender process is set to follow an open procurement method, with a total budget of £120,000. The contract period will commence on 1st August 2018 and last until 31st July 2021. A supplier open day event is scheduled for 27th April 2018, and interested parties must RSVP by 24th April 2018.

This tender presents a significant opportunity for businesses specialising in quality assurance services, specifically those involved in ISO certification for medical and biological products. Companies with expertise in compliance and regulatory standards in the healthcare sector, along with those providing support services to diagnostic device manufacturers, would be well-positioned to compete. Engaging in this process could facilitate growth and collaboration within this niche market, allowing successful bidders to contribute to vital public health initiatives while expanding their operational scope.

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Notice Title

Notified Body and ISO 13485 certificating body

Notice Description

The National Institute for Biological Standards and Control (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. We are holding a supplier open day event on 27th April 2018 from 10:30 am to 12:30 pm. If you want to attend and/or need further details about this event, please send an email to provided email address (nawaz.habib@nibsc.org) by close of play 24 April 2018.

Publication & Lifecycle

Open Contracting ID
ocds-b5fd17-c24da99f-70a7-4ce7-80cd-5f7f5baa9b72
Publication Source
Contracts Finder
Latest Notice
https://www.contractsfinder.service.gov.uk/Notice/88c775eb-6573-4b55-ac70-a9bcba517a08
Current Stage
Planning
All Stages
Planning

Procurement Classification

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

Common Procurement Vocabulary (CPV)

CPV Divisions

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


CPV Codes

72225000 - System quality assurance assessment and review services

Notice Value(s)

Tender Value
£120,000 £100K-£500K
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
24 Apr 20187 years ago
Submission Deadline
Not specified
Future Notice Date
6 May 2018Expired
Award Date
Not specified
Contract Period
31 Jul 2018 - 31 Jul 2021 3-4 years
Recurrence
Not specified

Notice Status

Tender Status
Planned
Lots Status
Not Specified
Awards Status
Not Specified
Contracts Status
Not Specified

Contracting Authority (Buyer)

Main Buyer
MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY
Contact Name
Nawaz Habib
Contact Email
nawaz.habib@nibsc.org
Contact Phone
01707641212

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

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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