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

This regulation sets out the essential requirements for medical devices, their classification, and the procedures for registering manufacturers and their products. It aims to ensure the safety and performance of medical devices placed on the market. Manufacturers and medical devices will be subject to registration in specific registers. This affects companies producing medical devices and ensures better oversight and traceability of these products.