Medical Devices Database
This page contains data on medical devices and in vitro diagnostic medical devices that, according to the records of the Agency for Medicinal Products and Medical Devices (HALMED), may be found on the Croatian market. Taking into account that natural and legal persons who place medical devices and/or in vitro diagnostic medical devices on the market of the Republic of Croatia are obliged to notify HALMED within a maximum of 15 days after placing the devices on the market, it is possible that some medical devices and in vitro diagnostic medical devices that are currently available on the market are not on HALMED's record at the given moment. In this sense, the data available here is intended for information purposes only and does not represent a complete list of all medical devices and in vitro diagnostic products that may be placed on the market and used in the territory of the Republic of Croatia based on the CE marking.
Medical device under Article 3 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC is any instrument, device, appliance, software, implant, reagent, material or other object intended by the manufacturer for use, alone or in combination, for human use for one or more of the following specified medical purposes:
- diagnosing, preventing, predicting, prognosticating, treating or alleviating illness
- diagnosing, monitoring, treating, alleviating or compensating for an injury or disability
- examination, replacement or alteration of anatomy or a physiological or pathological process or condition
- providing data through in vitro testing of samples obtained from the human body, including donated organs, blood and tissue
and which does not perform its main intended function by pharmacological, immunological or metabolic means but may be assisted by them, in or on the human body.
Products that are also considered medical devices:
- products for controling or aiding conception
- products specifically intended for the cleaning, disinfection or sterilization of medical devices, accessories for medical devices and products listed in Annex XVI of Regulation (EU) 2017/745.
In vitro diagnostic medical device is, according to Article 3 of the Medical Devices Act (Official Gazette, No. 76/13), any medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, device, equipment or system, whether used alone or in combination, intended by the manufacturer for in vitro testing of samples, including blood and tissue donations originating from the human body, solely or mainly for the purpose of obtaining data:
- to determine physiological or pathological condition
- to determine congenital anomalies
- to determine security and compatibility with the user
- to monitor therapeutic procedures.
Sample containers are also considered in vitro diagnostic medical devices.
Data on medical devices and in vitro diagnostic medical devices is classified into two databases:
- database that includes medical devices and in vitro diagnostic medical devices that were entered in the register of medical devices before 1 July 2013, available for search via the form "Database search (before 1 July 2013)", and
- database encompassing class I medical devices entered in the register of medical devices after 1 July 2013 and medical devices and in vitro diagnostic medical devices for which HALMED received a notification of placing on the Croatian market after 1 July 2013, available for search via forms "Database search according to subjects (after 1 July 2013)" and "Database by medical devices (after 1 July 2013)".
Data on individual products is entered into the database by automatic transmission of data received in electronic form from the notifier, so there is a possibility that it may contain errors. Due to large number of notifications received about placing on the market of medical and in vitro diagnostic medical devices, delays in the transfer of data to the databases may occur. Because of the same reason, the database may also contain products with expired documentation on the basis of which they were placed on the market.
Kindly send any information about possible errors in the database, as well as inquiries about the status of individual products, via e-mail to email@example.com.
Medical devices database may be searched via one or more criteria.
Search results can be exported into an Excel table (.xls file).
HALMED does not keep records of medical and in vitro diagnostic medical devices registered in the European Medicinal Products Database (EUDAMED).
A list of COVID-19 rapid antigen tests intended for self-testing, ie for personal and home use, for which HALMED has received a notification on placing on the Croatian market, and which are approved at the European Union level by a notified body, is available here (in Croatian).
A list containing additional information on all tests intended for COVID-19 pathogen testing, which are available in the European Union is available here.