Electronic instructions for use of medical devices
National legislation
Medical Devices Act (Official Gazette, No. 76/2013)
EU legislation
Competent authority
Ministry of Health, Agency for Medicinal Products and Medical Devices
Email: 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
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.
Main requirements that the business user needs to know about
National legislation does not contain technical requirements
National action
Medical Devices Act - Article 12. – 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.
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 medical devices
- Catalogue of Croatian Standards
- Notified bodies – Nando (EU) 2017/745
Link to the TRIS database
In the TRIS database you can look up the notification of the technical rule