View Expired Tender

Get immediate access to tenders like the one below by subscribing now to Tenders Direct. We will set up your personalised profile and send you tender alerts direct to your mailbox as soon as they are published. You will also benefit from having access to historical tenders.

Notice Summary

Title:
UK-Potters Bar: EU Authorised Representative (EAR / EC REP) (OPEN EARLY ENGAGEMENT)
Document Ref:
GB003ZM304996
Document Type:
Contract Notice - Other
Published By:
MHRA Buyer Organisation
Date Published:
07 August 2019
Deadline Date:
22 August 2019
Document Source:
Framework/DPS:
No
Alert Profile:
Labels:

Notice Abstract

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.

Notice Details

CONTRACT NOTICE – NATIONAL

SERVICES

1 Authority Details

1.1

Authority Name and Address

MHRA Buyer Organisation
Blanch lane, South Mimms
Potters Bar EN6 3QG UK
N/A N/A
nawaz.habib@nibsc.org N/A

1.2

Address from which documentation may be obtained

As in 1.1

1.3

Completed documents must be returned to:

As in 1.1

2 Contract Details

2.1

Title

EU Authorised Representative (EAR / EC REP) (OPEN EARLY ENGAGEMENT)

2.2

Description of the goods or services required

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.

2.3

Notice Coding and Classification

2.4

Total quantity or scope of tender

Location of contract:East of England, London, South East

3 Conditions for Participation

3.1

Minimum standards and qualification required

4 Administrative Information

4.1

Type of Procedure

The procedure type is unknown.

4.2

Reference number attributed to the notice by the contracting authority

n/a

4.3

Time Limits

   22-08-2019  Time 12:00

4.5

Language or languages in which tenders or requests to participate can be drawn up

EN 

4.6

Tender Submission Postbox

5 Other Information

5.1

Additional Information

Please visit the following portal to view this notice:

https://www.contractsfinder.service.gov.uk/Notice/5e6ad497-b31e-41d1-8a01-3ff1a7005a24?p=@FQxUlRRPT0=NjJNT08=U

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

(MT Ref:304996)

5.2

Additional Documentation

5.3

Publication date of this notice

 06-08-2019

Current Notes