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 investigations: 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
Competent authorities, procedures of competent authorities, supervision and misdemeanor provisions for the implementation of the regulation.
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 (Official Gazette No. 100/18): Article 30. – language requirements
Data and documents used for implementing the regulations referred to in Article 2 of this Act, which are intended to be used by patients and lay persons, shall be in the Croatian language. Data and documents used for implementing the regulations referred to in Article 2 of this Act, which are intended to be used by competent authorities or exclusively for the performance of healthcare activity, may be in the Croatian and/or English language.
In the TRIS database you can look up the notification of the technical rule