---
title: "EU Authorised Representative (EAR / EC REP)"
ocid: "ocds-b5fd17-3cc80a1e-b979-4c05-8105-72c93f934fb9"
canonical_url: "https://d3tenders.com/contract/?ocid=ocds-b5fd17-3cc80a1e-b979-4c05-8105-72c93f934fb9"
markdown_url: "https://d3tenders.com/contract/ocds-b5fd17-3cc80a1e-b979-4c05-8105-72c93f934fb9.md"
json_url: "https://d3tenders.com/contract/ocds-b5fd17-3cc80a1e-b979-4c05-8105-72c93f934fb9.json"
source: "Contracts Finder"
current_stage: "Planning"
buyer: "MHRA BUYER ORGANISATION"
published: "2019-07-26"
---

# EU Authorised Representative (EAR / EC REP)

Buyer: MHRA BUYER ORGANISATION  
Current stage: Planning  
OCID: ocds-b5fd17-3cc80a1e-b979-4c05-8105-72c93f934fb9

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## Summary

The procurement process for the "EU Authorised Representative (EAR / EC REP)" tender is currently in the planning stage, initiated by the MHRA Buyer Organisation located in Potter Bar, England. This tender, classified under the medical equipment and pharmaceuticals industry, involves engaging a legal entity to act as a liaison for NIBSC's in vitro diagnostic products within the EU. Key dates include the engagement end date set for 22nd August 2019, by which interested parties must register their interest via email to the contact point, Nawaz Habib.

This tender presents significant opportunities for businesses specialising in legal advisory and representation services, particularly those with expertise in regulatory compliance for medical devices and pharmaceuticals. Companies that can provide comprehensive services related to IVD products may find this an advantageous contract to pursue, especially if they are located within the EU. Small and medium-sized enterprises (SMEs) are encouraged to participate, as the procurement aims to attract diverse suppliers capable of meeting the specified requirements.

## Notice

The agency is looking for a provider which can serve as a legal entity designated by one of its centre (NIBSC) and act as liaison between NIBSC as a manufacturer of CE-marked IVD products and represent NIBSC within relevant EU countries ensuring compliance with European Directives to provide the following services: - Have a base of operation located within an EU country. - Review Technical Files and other regulatory documentation of relevant in vitro Diagnostic Devices (IVDs) for compliance to European Directives for the purposes of registering the devices with an EU Competent Authority and respond to any resulting questions or comments. - Register relevant IVD products with an EU Competent Authority for the purposes of sale within the EU. - Provide identification details to be placed onto the labelling of IVDs sold throughout the EU. - Process requests for and take copies of IVD product regulatory documentation including Technical Files, labelling information, certificates and CE Declaration of Conformities and make them available to requesting Competent Authorities. - Handle any complaints from Competent Authorities or customers within EU countries. - Provide a function for reporting Incidents and Field Safety Corrective Actions (FSCA) in cooperation with NIBSC and relevant customers as necessary. If you can provide a service that meets these requirements, please email to Nawaz Habib (nawaz.habib@nibsc.org) to register an interest. If no submissions (by close of play 22/08/2019) of potential interest are received, it is then intended to perform a direct award without competition to the supplier we believe can provide this service.

## Key Details

| Field | Value |
| --- | --- |
| Publication source | Contracts Finder |
| Latest notice | https://www.contractsfinder.service.gov.uk/Notice/5e6ad497-b31e-41d1-8a01-3ff1a7005a24 |
| Notice type | Market Engagement Notice |
| Procurement type | Standard |
| Procurement category | Not specified |
| Procurement method | Not Specified |
| Procurement method details | Not specified |
| Tender suitability | SME |
| Awardee scale | Not specified |
| All stages | Planning |

## Dates

| Field | Value |
| --- | --- |
| Publication date | 26 Jul 2019 |
| Submission deadline | Not specified |
| Future notice date | 22 Aug 2019 |
| Award date | Not specified |
| Contract period | Not specified |
| Recurrence | Not specified |

## Values

| Field | Value |
| --- | --- |
| Tender value | Not specified |
| Lots value | Not specified |
| Awards value | Not specified |
| Contracts value | Not specified |

## Status

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

## Buyer

| Field | Value |
| --- | --- |
| Main buyer | MHRA BUYER ORGANISATION |
| Locality | POTTER BAR |
| 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 | TLI London, TLJ South East (England) |

## CPV Codes

### Divisions

- 33 - Medical equipments, pharmaceuticals and personal care products
- 73 - Research and development services and related consultancy services
- 79 - Business services: law, marketing, consulting, recruitment, printing and security

### Codes

- 33000000 - Medical equipments, pharmaceuticals and personal care products
- 33100000 - Medical equipments
- 33190000 - Miscellaneous medical devices and products
- 33600000 - Pharmaceutical products
- 73111000 - Research laboratory services
- 79110000 - Legal advisory and representation services
- 79112000 - Legal representation services

## Release History

- 26 Jul 2019 at 17:58 - Planning - Market Engagement Notice - https://www.contractsfinder.service.gov.uk/Notice/5e6ad497-b31e-41d1-8a01-3ff1a7005a24

## Documents

- https://www.contractsfinder.service.gov.uk/Notice/5e6ad497-b31e-41d1-8a01-3ff1a7005a24
  26th July 2019 - Early engagement notice on Contracts Finder

## 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-b5fd17-3cc80a1e-b979-4c05-8105-72c93f934fb9. The underlying structured data is available as OCDS JSON at https://d3tenders.com/contract/ocds-b5fd17-3cc80a1e-b979-4c05-8105-72c93f934fb9.json.