For manufacturers and distributors based outside of the European Union, appointing an Authorized European Representative is an essential step to market in the region. High Edge provides the EU Authorized Rep service as a gateway to the European market.
With High Edge Authorized Rep clients receive expert and intimate knowledge of all three Medical Device Directives from medical device specialists.
What does it include?
- We will register your device with the UK Competent Authority (MHRA).
- Hold and maintain up to date copies of your technical files and/or design dossiers.
- The authorisation to include the ‘EC Rep’ symbol with the High Edge Authorized Rep name and our contact details on your packaging and all required literature.
- We act as a local and responsive conduit between you, your customers in the EU, Competent Authority and Notified Body in the region.
- As medical device regulation experts, we can assist in a responsive and practical way as regulatory issues may arise.
- Consultancy services to meet the European regulatory and quality needs.