Planning

EU Authorised Representative (EAR / EC REP)

MHRA BUYER ORGANISATION

This public procurement record has 1 release in its history.

Planning

26 Jul 2019 at 17:58

Market Engagement Notice
Summary of the contracting process

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.

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Notice Information

Notice Title

EU Authorised Representative (EAR / EC REP)

Notice Description

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.

Notice Details

Publication & Lifecycle

Open Contracting ID
ocds-b5fd17-3cc80a1e-b979-4c05-8105-72c93f934fb9
Publication Source
Contracts Finder
Latest Notice
https://www.contractsfinder.service.gov.uk/Notice/5e6ad497-b31e-41d1-8a01-3ff1a7005a24
Current Stage
Planning
All Stages
Planning

Procurement Classification

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

Common Procurement Vocabulary (CPV)

CPV 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

CPV 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

Notice Value(s)

Tender Value
Not specified
Lots Value
Not specified
Awards Value
Not specified
Contracts Value
Not specified

Notice Dates

Publication Date
26 Jul 20196 years ago
Submission Deadline
Not specified
Future Notice Date
22 Aug 2019Expired
Award Date
Not specified
Contract Period
Not specified - Not specified
Recurrence
Not specified

Notice Status

Tender Status
Planning
Lots Status
Not Specified
Awards Status
Not Specified
Contracts Status
Not Specified

Buyer & Supplier

Contracting Authority (Buyer)

Main Buyer
MHRA BUYER ORGANISATION
Contact Name
Available with D3 Tenders Premium →
Contact Email
Available with D3 Tenders Premium →
Contact Phone
Available with D3 Tenders Premium →

Buyer Location

Locality
POTTER BAR
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
TLI London, TLJ South East (England)
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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