Medical Devices

Notification of placing a medical device on the Croatian market

According to Article 42. of Medical Devices Act (Official Gazette, no. 76/13) and Articles 41.-45. of Ordinance on Essential Requirements, Classification, Registration of Manufacturers in the Register of Medical Device Manufacturers, Registration of Medical Devices in the Register of Medical Devices and Conformity Assessment of Medical Devices (Official Gazette, no. 84/13, 126/19, 32/21) legal and natural persons who place medical devices on the market of the Republic of Croatia classified as Class IIa, IIb and III, in vitro diagnostic medical devices and active implantable medical devices shall notify the Agency within a time period not exceeding 15 days from the day on which these products are placed on the market.

Notification of placing the medical devices on the Croatian market should be sent directly to HALMED via medpro@halmed.hr e-mail address, or through a local distributor.

The notification e-mail should have the following title: Notification about placing on the market_name of manufacturer_name of product or product group and must have the following documents included:

1. Notification Form - for medical device class IIa, IIb and III (MEDPRO-II/III, .docx) or for IVD medical devices, .docx)
2. List of devices - Excel Template for the list of individual medical devices is available here
3. Declaration of Conformity, EC certificate (in ZIP file format)
4. Labelling - IFU and labels (in ZIP file format)
5. Proof of payment for issuing confirmation letter for notification of placing a medical device on the Croatian market or issuing confirmation letter for variation of notification of placing a medical device on the Croatian market - HALMED’s price list is available here. HALMED invoices web application should be used for payment

One MEDPRO form may be sent for several medical devices (DoC-s) as long as they are covered with the same EC certificate.

Change of notification about placing a medical device on the Croatian market

If something has changed with regard to the documentation that was attached during the initial notification about placing the medical devices on the Croatian market, the change of the notification shall be processed in accordance with Article 42 (3) of the Act on Medical Products (Official Gazette, No. 76/13)

Notice of change must be sent with a reference to the last classification mark (530-09/…) of the Agency's confirmation, clearly state what has changed and have the following documents attached:

1. Notification form:
   - Form for notification of medical product of risk class IIa, IIb and III (Form MEDPRO-II/III, .docx)
   - Form for notification of "in vitro" diagnostic medical product (Form IVD-MEDPRO, .docx)
2. New list of products (if there have been changes) - template available here
3. Other documentation, depending on the change:
   - Certificate of conformity (EC Certificate)
   - Manufacturer's statement related to Regulation (EC) 2023/607
   - Confirmation letter issued by the Notified Body related to Regulation (EC) 2023/607
   - Declaration of Conformity
   - Labeling and instructions for use (IFU)
4. Proof of payment for the notification procedure - HALMED’s price list is available here

(For example, changing the manufacturer's address will automatically trigger a change in labeling, instructions, Declaration of Conformity and EC certificates)

The notification about placing medical devices on the Croatian market is not mandatory if the medical device is already registered within the EUDAMED database (Croatia stated in the Market distribution section).

For further inquiries please contact medpro@halmed.hr.