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News and Views March 2017

New Medical Device Regulation (MDR) in Europe
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8. Medical Device Networking Meeting
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Starting July 1, 2013, Croatia is an official member of the European Union

Many laws and regulations on medical devices have already been adjusted to the European requirements. The responsible entity for the registration of medical devices in Croatia id the Agency for Drugs and Medical Devices in Croatia (HALMED). The contact address can be found at www.halmed.hr (Croatian/English).

The most important facts:

  • Medical devices (except risk class I ) and in vitro diagnostic devices must be registered in Croatia by the manufacturer or the distributor
  • Information made available to the user (instructions for use, labels) must be in Croatian language

Medical Device Act (New): http://narodne-novine.nn.hr/clanci/sluzbeni/2013_06_76_1521.html (Croatian only)

Medical Device Act (obsolete): http://www.halmed.hr/upl/zakoni/zakoni_30_en.pdf

Ordinance on Essential Requirements, Classification, Quality System, Entry into the Register of Manufacturers and Register of Medical Devices and Assessment of Conformity of Medical Devices: http://www.halmed.hr/upl/zakoni/zakoni_42_en.pdf