---
title: "Notified body and ISO13485:2016 certification body"
ocid: "ocds-b5fd17-ff24a355-273a-4bb9-8e14-5853b9518608"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-ff24a355-273a-4bb9-8e14-5853b9518608"
markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-ff24a355-273a-4bb9-8e14-5853b9518608.md"
json_url: "https://d3tenders.com/contract/ocds-b5fd17-ff24a355-273a-4bb9-8e14-5853b9518608.json"
source: "Contracts Finder"
current_stage: "Award"
buyer: "MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY"
published: "2018-11-30"
---

# Notified body and ISO13485:2016 certification body

Buyer: MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY  
Current stage: Award  
OCID: ocds-b5fd17-ff24a355-273a-4bb9-8e14-5853b9518608

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## Summary

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.

## Notice

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.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Contracts Finder |
| Latest notice | https://www.contractsfinder.service.gov.uk/Notice/a245ed15-8cbc-4260-a4ce-79689f2ecd48 |
| 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 |
| All stages | Tender, Award |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 30 Nov 2018 |
| Submission deadline | 3 Jul 2018 |
| Future notice date | Not specified |
| Award date | 6 Sep 2018 |
| Contract period | 20 Sep 2018 - 20 Sep 2021 |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | Not specified |
| Lots value | Not specified |
| Awards value | £47,000 |
| Contracts value | Not specified |

## Status

| Field | Value |
| --- | --- |
| Tender status | Complete |
| Lots status | Not specified |
| Awards status | Active |
| 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 |

## Supplier

| Field | Value |
| --- | --- |
| Number of suppliers | 1 |
| Supplier names | UL INTERNATIONAL (UK |

## CPV Codes

### 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

### Codes

- 50433000 - Calibration services
- 71730000 - Industrial inspection services
- 72225000 - System quality assurance assessment and review services
- 79212000 - Auditing services
- 90714500 - Environmental quality control services

## Release History

- 30 Nov 2018 at 14:49 - Award - Award Notice - https://www.contractsfinder.service.gov.uk/Notice/a245ed15-8cbc-4260-a4ce-79689f2ecd48
- 4 Jun 2018 at 13:17 - Tender - Tender Notice - https://www.contractsfinder.service.gov.uk/Notice/9c6c7f21-3e6b-453d-a543-6fe84fc187bf

## Documents

- https://www.contractsfinder.service.gov.uk/Notice/a245ed15-8cbc-4260-a4ce-79689f2ecd48
  30th November 2018 - Awarded contract notice on Contracts Finder
- https://www.contractsfinder.service.gov.uk/Notice/9c6c7f21-3e6b-453d-a543-6fe84fc187bf
  4th June 2018 - Opportunity notice on Contracts Finder
- https://mhra.bravosolution.co.uk/web_mhra/login.html
  MHRA Bravo 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-ff24a355-273a-4bb9-8e14-5853b9518608. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-b5fd17-ff24a355-273a-4bb9-8e14-5853b9518608.json.