Medical Device Registration in Croatia

Placing your medical device into the European market is contingent upon your compliance with the Medical Device Directive 93/42/EEC. While this Directive is a law to all 28 member states within the European Union, each member state has its own way of implementing the Directive within their country, essentially adding regulations to the Directive and creating Local Legislation.

An example of such local implementation of the Directive is now present in Croatia. As a non-EU manufacturer of medical devices, you are required to use a European (legal) representative to register your medical device with the Croatian database. Non-Croatian manufacturers that are based in European Union are also required to complete this registration themselves or appoint a legally-mandated representative to register for them.

National registration is required for upper class Medical Devices and IVDs. The registration shall be performed by the person placing the device on the market. However, the EC Rep is allowed to perform the registration as well.

Registration Process

Notifications of placing a medical device on the market are submitted by legal and natural persons who place on the market Class IIa, IIb and III medical devices, in vitro diagnostic medical devices and active implantable medical devices.

Notifications of placing a medical device on the market are sent to the Agency in writing, no later than 15 days from the day of placing the medical device on the market.

The documentation to be submitted with the notification of placing a medical device and in vitro diagnostic medical device is set out in Articles 43 (for medical devices) and 44 (for in vitro diagnostics) of the 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).

Documentation to register an Upper class medical device includes:

  • MEDPRO-II / III form filled in, which is set out in Annex 3 to Ordinance No. 84/13;
  • manufacturer’s declaration of conformity with essential requirements;
  • certificate of conformity of the notified body;
  • marking and instructions for use, in accordance with Article 12 of the Act;
  • a list of medical products in electronic form.

Documentation to be submitted to register an IVD device includes:

  • completed form IVD-MEDPRO, set out in Annex 4 to Ordinance No. 84/13;
  • manufacturer’s declaration of conformity with essential requirements;
  • a certificate of conformity of the notified body, if applicable;
  • marking and instructions for use, in accordance with Article 12 of the In vitro Diagnostic Medical Products Act contained in Annex II to Ordinance No. 84/13 for “in vitro” diagnostic medical products as well as for “in vitro” diagnostic medical products for self-testing;
  • a list of “in vitro” diagnostic medical products in electronic form.

According to art. 45 of Ordinance No. 84/13, legal and natural persons that registered an Upper Class medical device or IVD shall be obliged to report any amendment and modification to the information and documentation they have submitted when filing the notice, and in the case of documents issued for a certain period after the expiration of that period, they are obliged to submit valid documents.

Third party commercial entities, like distributors, should not register your medical devices for several reasons, a few of which are:

  1. By allowing a third party commercial entity to register in your behalf, the manufacturer relinquishes an essential part of his control over his medical device in Croatia;
  2. If you decided to end the relationship with your commercial distributor at any point, you would be required to take your medical device completely off the market until you could re-register that medical device within Croatia for a second (third, fourth, etc.) time;
  3. Your third party commercial entity will expect exclusivity, limiting the open distribution of your medical device.

Conclusion

  1. For the benefit of non-EU manufacturer, the distributor SHOULD NOT have part in any regulatory affairs
  2. The manufacturer should register their medical devices with the Croatian database through his appointed Authorized Representative

Local Legislations, such as this one, are growing rapidly in Europe (Italy, Portugal, France, Greece, Latvia, Bulgaria and Latvia) and strengthen the need for a professional European Authorized Representative present at any time.


Do you need more information? Contact us, our Team will be happy to assist you!

Get in touch