Pravilnik o bitnim zahtjevima, razvrstavanju, upisu proizvođača u očevidnik proizvođača, upisu medicinskih proizvoda u očevidnik medicinskih proizvoda te ocjenjivanju sukladnosti medicinskih proizvoda

This Croatian regulation establishes the essential safety and performance requirements for medical devices. It sets out the rules for classifying these products, registering manufacturers, and maintaining a formal registry of medical devices to ensure public health and safety. This affects manufacturers and importers of medical devices operating in Croatia, requiring them to undergo conformity assessments and register their products before they can be placed on the market.