European Authorized Representative
We provide a quality service as your EAR
Non-European manufacturers of medical devices without an establishment within the European Union are required to have a European Authorized Representative (E.A.R.) to be in compliance with the European Medical Device Directives. A European Authorized Representative serves as your contact point with the various competent authorities of the EU member states and supports you in regulatory matters.
Our basic services as a European Authorized Representative include:
- Qualified regulatory support in compliance to all EU applicable regulations and guidelines
- A competent contact point to all competent authorities of EU member states
Additional Services:
- Supporting the development of necessary technical documentation and a quality system to fulfill European
requirements
- Support with global strategy and dossier management
-Through our understanding and experience of the regulations in the different markets we can streamline your
submission management and shorten the time to market.
- Integration with reimbursement activities
-Several aspects of the regulatory work overlap with those of reimbursement. By working with us, we can align
the work from these two areas to ensure quicker market access at lower cost.