European Authorized Representative Agreement For Medical Devices
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FAQ
From 16 July 2021 you will need to appoint an authorised representative based in the EU, EEA or Northern Ireland if you sell certain goods without using an importer or fulfilment service provider, for example if you sell online and ship directly to the end user.
European Authorized RepresentativeProviding a registered address within the European Union.Keeping all technical documentation available for inspection by the European Authorities.Completing notifications to European Authorities.Completing any registrations to national databases.Taking care of any incident reporting.More items...
An EU representative is the point of contact for EU data subjects and data protection supervisory authorities. The representative acts on behalf of a controller or processor with regard to their obligations under the GDPR.
In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements of the Medical Devices Directive (MDD), or Active Implantable Medical Device Directive (AIMD) as they apply to your product.
Do we have to put the name of the Authorized Representative on our labeling, packaging and IFUs? Yes. You must list the name and address of the Authorized Rep on the product label, outer packaging and/or Instructions for Use.
