Published date: 26 July 2019
Closed early engagement
Contract summary
Industry
Medical equipments, pharmaceuticals and personal care products - 33000000
Medical equipments - 33100000
Miscellaneous medical devices and products - 33190000
Pharmaceutical products - 33600000
Research laboratory services - 73111000
Legal advisory and representation services - 79110000
Legal representation services - 79112000
Location of contract
East of England, London, South East
Procurement reference
tender_164001/787235
Published date
26 July 2019
Closing date
22 August 2019
Contract is suitable for SMEs?
Yes
Contract is suitable for VCSEs?
No
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.
About the buyer
Address
Blanch lane, South Mimms
Potter Bar
EN6 3QG
England
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Closing date: 22 August 2019