EU Authorised Representative (EAR / EC REP)
No value published
MHRA Buyer Organisation publishes Medical Equipment & Pharmaceuticals work continuously — 18 notices, roughly one every 6 days. This is a stream to watch, not a cycle to wait for.
27% of MHRA Buyer Organisation’s awards go to a supplier it has used before.
Which is the argument for getting on the list rather than winning this one. The incumbent is rarely the last winner — it is the roster. See the retention odds by category →
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.
What the notice asks for
Provide identification details to be placed onto
Provide identification details to be placed onto the labelling of IVDs sold throughout the EU.
Provide a function for reporting Incidents
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
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
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.
Sentences from the notice that state an obligation, surfaced automatically and shown in the order they appear. Not an exhaustive list — always confirm against the tender documents.
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- OCID
- 5e6ad497-b31e-41d1-8a01-3ff1a7005a24
- Stage
- preprocurement · Closed
- Source
- Contracts Finder
- Buyer ref
- tender_164001/787235
Contains public sector information licensed under the Open Government Licence v3.0. Source data © Crown copyright.
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