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 Authorized Representative of choice.
Important things to consider:
- Non EU companies require a representative domiciled in the EU prior to placing their devices on the EU market.
- National authorities will require an EU representative during clinical investigations with non CE marked devices.
- Competent authorities expect high level expertise from EU representatives.
- Different national requirements exist for specific product procedures, market access notifications, labelling, and vigilance reporting.
For more information on our Medial Device group and service offerings, please contact us.
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