A manufacturer having his registered place of business in the Republic of Croatia may request an opinion from the Agency for Medicinal Products and Medical Devices on the classification of a device into a group of medical devices or on the classification of a medical device into the appropriate risk class. The applicant must submit a request for the classification of a device in Croatian language, and must submit documentation containing the description and intended use of the device with the application. The Agency will issue its opinion on the classification of the medical device into the appropriate risk class in accordance with the classification rules set out in Annex IX to the Ordinance on Essential Requirements, Classification, Registration of Manufacturers in the Register of Medical Device Manufacturers, Registration of Medical Devices in the Register of Medical Devices and Conformity Assessment of Medical Devices (Official Gazette, no. 84/13).
If the manufacturer classifies a product as a medical device, while the same product is deemed by the Agency to fall into another product group (medicinal products, cosmetic products, food supplements), the Agency will issue a written opinion to that effect.