Rozporządzenie Ministra Zdrowia z dnia 17 lutego 2016 r. w sprawie wymagań zasadniczych oraz procedur oceny zgodności wyrobów medycznych

This regulation establishes the basic requirements and the procedures for assessing whether medical devices comply with safety and quality standards before they can be placed on the market. It ensures that healthcare products are safe for patients and medical professionals. The rules affect manufacturers, importers, and distributors of medical devices in Poland, requiring them to follow specific certification and testing protocols.