Notification of placing a medical device on the Croatian market
As of May 28, 2026, an additional six-month period has begun for the registration of medical devices that were placed on the market before the date of mandatory use of the medical devices module. These products must be registered in the EUDAMED database by November 28, 2026. Medical devices that are placed on the market for the first time on or after the date of mandatory use of the relevant module must be registered before being placed on the market.
Pursuant to the aforementioned obligation, the Agency received notifications of the placing of medical devices on the market until October 27, 2026, given that the transition period for the mandatory entry of data on medical devices into the European Database on Medical Devices (EUDAMED) ends on November 28, 2026.
Medical devices complying with Regulation (EU) 2017/745 or Regulation (EU) 2017/746, as applicable, may continue to be placed on the Croatian market.
The obligations of distributors of medical devices laid down in Article 14, and the obligations of importers laid down in Article 13 of Regulation (EU) 2017/745 or Regulation (EU) 2017/746, as applicable depending on the type of device, apply.
For further inquiries please contact medpro@halmed.hr.
