EU Authorised Representative (EAR / EC REP)
MHRA Buyer Organisation · United Kingdom
Key facts
- Engagement closes
- 22 Aug 2019
- Buyer type
- Other public body
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 ([email protected]) 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.
Categories (CPV)
- 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
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