Description of the goods or services required
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.