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European Authorized Representative

European Authorized Representative: Understanding the Role of an EU Representative

September 28, 2026

Expanding your business into the European Union (EU) offers exciting opportunities to reach new customers and grow internationally. However, entering the European market also involves understanding regulatory requirements, product compliance, and legal responsibilities. For manufacturers located outside the EU, appointing a European Authorized Representative can be an essential step toward meeting applicable European regulations and ensuring smooth market access. An EU Representative acts as a designated point of contact between a non-EU manufacturer and European authorities, helping businesses fulfill specific...

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What Is a European Authorized Representative and When Does Your Medical Device Business Need One?

July 28, 2026

Expanding into the European medical device market opens valuable opportunities for manufacturers worldwide. However, selling medical devices in Europe involves more than meeting product quality expectations. Manufacturers located outside the European Union must also comply with specific legal responsibilities before placing their devices on the market. One of the most important requirements under the European Medical Device Regulation (EU MDR) is appointing a European Authorized Representative. This representative acts as the official point of contact between non-EU manufacturers and European...

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