From EU regulation (MDR/IVDR) to the specific Italian Guidelines of 2025: this white paper covers the fundamental principles and rules for promoting Medical Devices in the European Union and specifically in Italian territory, ensuring ethics, truthfulness, and full compliance.
1. INTRODUCTION AND CONTEXT
To establish effective health communication strategies in medical device communication, it is necessary to comply with complex and constantly evolving rules that vary based on the territory to which the promotion is directed. An error in communication does not only lead to monetary penalties but also to reputational damage, potentially resulting in the blocking of commercialization.
