Authorized Representative in European Union

MedDARE, the easy solution for non EU companies to meet EU and national requirements

For non EU companies seeking their place on the European market, MedDARE provides a simple and intelligent solution to meet mandatory European Representative requirements.  Through expert regulatory know-how and close contacts with Competent Authorities and European Commission, MedDARE is the EU Authorised Representative of choice.

Important things you should consider:

• Non EU companies require an Authorised Representative domiciled in the EU prior to placing their devices on the EU market.
• Some national authorities will require an EU authorized representative during Clinical Investigations with non CE marked devices
• Competent authorities expect high level expertise from EU Authorised Representatives.
• Different national requirements exist for market access notifications, labeling, safety and vigilance reporting.

To find out how MedDARe can make your European debut a success please contact us