Active implantable medical devices and medical devices manufactured utilising tissues of animal origin

 

National legislation

Medical Devices Act (Official Gazette, No. 76/2013)

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

Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin

 

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. 100/2018): 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.
 

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
farmaceutska.inspekcija@miz.hr

 

• List of harmonised standards for medical devices
• Catalogue of Croatian Standards
• Notified bodies – Nando (EU) 2017/745
• Accredited bodies

 

Link to the TRIS database

In the TRIS database you can look up the notification of the technical rule