Source: https://tendernation.io/opportunities/01a13c38-f90b-72e4-9f1d-f75fbc041b2f/eu-authorised-representative-ear-ec-rep pending GB open procedure Suitable for SMEs # EU Authorised Representative (EAR / EC REP) [MHRA Buyer Organisation](https://tendernation.io/buyers/mhra-buyer-organisation) Estimated value Not stated Published 26 Jul 2019 Deadline Rolling deadline ## Who can bid - Buyer says suitable for SMEs The buyer ticked “suitable for SMEs” on the notice. Anyone can still bid. - Open procedure Anyone can submit a full tender; there is no shortlisting stage. [More contracts for small businesses and VCSEs](https://tendernation.io/opportunities/for-small-businesses) ## About this tender 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 () 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. Read full description ## CPV classification Medical equipments, pharmaceuticals and personal care products Source Contracts Finder (UK) [View official notice](https://www.contractsfinder.service.gov.uk/notice/3cc80a1e-b979-4c05-8105-72c93f934fb9) Never miss a tender like this again Get AI summaries, deadline alerts and a bid pipeline for tenders matched to your business. Free to start. [Track tenders free](https://tendernation.io/register) [Buyer profile MHRA Buyer Organisation: past awards and live tenders](https://tendernation.io/buyers/mhra-buyer-organisation) [Sector More Medical equipment & pharmaceuticals tenders](https://tendernation.io/sectors/medical-equipment-pharmaceuticals) ## More tenders like this [Blood-grouping reagents – ΑΝΤΙΔΡΑΣΤΗΡΙΑ ΑΙΜΟΔΟΣΙΑΣ · ΓΕΝΙΚΟ ΝΟΣΟΚΟΜΕΙΟ ΔΡΑΜΑΣ · 46 days left · 4 Dec 2026](https://tendernation.io/opportunities/01a15183-2813-7182-8d99-b716cf03c730/greece-blood-grouping-reagents-antidrasthria-aimodosias) [Medical consumables – Kärlkateterlås · Region Jönköpings län · 30 days left · 17 Nov 2026](https://tendernation.io/opportunities/01a15183-2a9a-72d4-bb06-f03d9172406e/sweden-medical-consumables-karlkateterlas) [Miscellaneous medical devices and products – DOSTAWA AKCESORIÓW DO SPRZĘTÓW MEDYCZNYCH DLA UNIWERSYTECKIEGO SZPITALA KLINICZNEGO W RADOMSKU. · Uniwersytecki Szpital Kliniczny · 11 days left · 30 Oct 2026](https://tendernation.io/opportunities/01a15183-0b5a-71e9-a08d-e181d06851b0/poland-miscellaneous-medical-devices-and-products-dostawa-akcesoriow-do-sprz) [Medical consumables – Zakup środków ochrony indywidualnej, rękawiczek, pokrowców i sprzętu unieruchamiającego · Wojewódzka Stacja Pogotowia Ratunkowego i Transportu Sanitarnego "Meditrans" Samodzielny Publiczny Zakład Opieki Zdrowotnej w Warszawie · 29 days left · 17 Nov 2026](https://tendernation.io/opportunities/01a15183-1d96-73a3-a8b8-1b3d8556abf8/poland-medical-consumables-zakup-srodkow-ochrony-indywidualnej-rekawiczek) [Devices and instruments for infusion – Infusionspump TPN · Västra Götalandsregionen · 30 days left · 17 Nov 2026](https://tendernation.io/opportunities/01a15183-28be-7144-8e47-d1110f2f2cc8/sweden-devices-and-instruments-for-infusion-infusionspump-tpn) [Medical equipments – Dostawy asortymentu wielorazowego na okres 24 miesięcy - sprawa nr Z/95/PN/26 · Regionalny Szpital Specjalistyczny im. dr Władysława Biegańskiego · 11 days left · 30 Oct 2026](https://tendernation.io/opportunities/01a15183-3711-7240-9b25-1a923d673777/poland-medical-equipments-dostawy-asortymentu-wielorazowego-na-okres-24-mies)