What Is a European Authorized Representative and When Does Your Medical Device Business Need One?
July 28, 2026Expanding 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...