EU Representative & EUDAMED Services

We offer professional services as EU Authorised Representative for medical device manufacturers outside the European Union who wish to distribute their products in the European market.

As your official EU representative, we handle the legal representation of your company within the European Union and ensure that all requirements of the EU Medical Device Regulation (MDR) be fully fulfilled.

A key component of our work is providing support with registration and administration within the EUDAMED database, including the proper registration of companies and products in accordance with applicable EU regulations.

Your reliable partner for EU market access

For manufacturers outside the EU, the designation of a EU Representative Legally required. We act as your reliable contact person with European authorities and guide you through all regulatory requirements.

Our goal is to enable you to have smooth and legally compliant access to the European market while reducing administrative and regulatory complexity for your company.