---
title: "Notified Body and ISO 13485 certificating body"
ocid: "ocds-b5fd17-c24da99f-70a7-4ce7-80cd-5f7f5baa9b72"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-c24da99f-70a7-4ce7-80cd-5f7f5baa9b72"
markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-c24da99f-70a7-4ce7-80cd-5f7f5baa9b72.md"
json_url: "https://d3tenders.com/contract/ocds-b5fd17-c24da99f-70a7-4ce7-80cd-5f7f5baa9b72.json"
source: "Contracts Finder"
current_stage: "Planning"
buyer: "MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY"
published: "2018-04-24"
---

# Notified Body and ISO 13485 certificating body

Buyer: MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY  
Current stage: Planning  
OCID: ocds-b5fd17-c24da99f-70a7-4ce7-80cd-5f7f5baa9b72

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## Summary

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.

## Notice

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.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Contracts Finder |
| Latest notice | https://www.contractsfinder.service.gov.uk/Notice/88c775eb-6573-4b55-ac70-a9bcba517a08 |
| 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 |
| All stages | Planning |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 24 Apr 2018 |
| Submission deadline | Not specified |
| Future notice date | 6 May 2018 |
| Award date | Not specified |
| Contract period | 31 Jul 2018 - 31 Jul 2021 |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | £120,000 |
| Lots value | Not specified |
| Awards value | Not specified |
| Contracts value | Not specified |

## Status

| Field | Value |
| --- | --- |
| Tender status | Planned |
| Lots status | Not specified |
| Awards status | Not specified |
| Contracts status | Not specified |

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY |
| Locality | POTTERS BAR, HERTFORDSHIRE |
| Post town | Enfield |
| Postcode | EN6 3QG |
| Country | England |
| ITL 1 | TLH East (England) |
| ITL 2 | TLH2 Bedfordshire and Hertfordshire |
| ITL 3 | TLH27 South West Hertfordshire |
| Local authority | Hertsmere |
| Electoral ward | Shenley |
| Westminster constituency | Hertsmere |
| Delivery location | Not specified |

## CPV Codes

### Divisions

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

### Codes

- 72225000 - System quality assurance assessment and review services

## Release History

- 24 Apr 2018 at 10:30 - Planning - Planned Procurement Notice - https://www.contractsfinder.service.gov.uk/Notice/88c775eb-6573-4b55-ac70-a9bcba517a08
- 15 Mar 2018 at 17:08 - Planning - Planned Procurement Notice - https://www.contractsfinder.service.gov.uk/Notice/88c775eb-6573-4b55-ac70-a9bcba517a08

## Documents

- https://www.contractsfinder.service.gov.uk/Notice/88c775eb-6573-4b55-ac70-a9bcba517a08
  24th April 2018 - Future opportunity notice on Contracts Finder
- https://mhra.bravosolution.co.uk/web_mhra/login.html
  MHRA e-procurement portal

## Provenance

This Markdown file is an alternate public rendering of the D3 Tenders contract record. The canonical page is https://d3tenders.com/contract/?ocid=ocds-b5fd17-c24da99f-70a7-4ce7-80cd-5f7f5baa9b72. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-b5fd17-c24da99f-70a7-4ce7-80cd-5f7f5baa9b72.json.