EU and UK Medical Device Representation Explained
August 27, 2026Selling medical devices across international markets requires more than developing a safe and effective product. Manufacturers must also understand local regulatory obligations, documentation requirements, and communication responsibilities. For companies located outside Europe or the United Kingdom, appointing the appropriate regulatory representative can be an essential part of market entry. Two roles that are frequently discussed are the EU Representative and UK Responsible person. While both provide a regulatory connection between overseas manufacturers and local authorities, they operate under different legal frameworks and serve...
