Nařízení vlády č. 54/2015 Sb., o technických požadavcích na zdravotnické prostředky
This regulation sets out the technical requirements for medical devices sold in the Czech Republic. It ensures that these products meet safety and performance standards before they can be placed on the market. Manufacturers and distributors of medical devices must comply with these rules. The regulation aims to protect public health and ensure the proper functioning of the healthcare system.