Act Implementing Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (Official Gazette, No. 100/2018)
Ministry of Health, Agency for Medicinal Products and Medical Devices
Email: Clinical investigation: romana.katalinic@miz.hr
General contact, registration procedures, device qualification and classification, vigilance: medpro@halmed.hr
Phone: +385 1 46 07 555, +385 1 48 84 100
Web: https://zdravlje.gov.hr/, https://www.halmed.hr/en/
Ministry of Health
Email: farmaceutska.inspekcija@miz.hr
Requirements for medical devices, clinical trials of medical devices, entry into the register of medical devices manufacturers, conformity assessment and CE markings, conformity assessment bodies, registration, placing on the market, advertising, vigilance and supervision and control of medical devices.
National legislation does not contain technical requirements
Act Implementing Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices - Article 30 – language requirements
The instructions for use and labelling of the medical device must be in the Croatian language and appear in a visible and legible and form. The instructions for use of medical devices exclusively intended for use by medical institutions must be supplied in a language which is known by the user.
In the TRIS database you can look up the notification of the technical rule