In vitro diagnostic medical devices 2
National legislation
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)
EU legislation
Competent authority
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/
Market Surveillance Authority
Ministry of Health
Email: farmaceutska.inspekcija@miz.hr
Scope of application
Competent authorities, procedures of competent authorities, supervision and misdemeanor provisions for the implementation of the regulation.
Main requirements that the business user needs to know about
National legislation does not contain technical requirements
National action
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.
- List of harmonised standards for in vitro diagnostic medical devices
- Catalogue of Croatian Standards
- Notified bodies – Nando (EU) 2017/746
- Accredited bodies
Link to the TRIS database
In the TRIS database you can look up the notification of the technical rule