By Stewart Eisenhart, Emergo Group
Now that Croatia has become a fully fledged member of the European Union, medical device manufacturers should begin considering whether the new member state’s medical device market presents new commercialization opportunities.
The Agency for Medical Products and Medical Devices (Halmed), Croatia’s medical device market regulator, continues work to bring the country’s registration requirements more closely to those of the European Medical Device Directives, but the Croatian medical device regulatory system is not yet fully aligned with EU rules.
Although CE marking for medical devices is not yet required in Croatia, manufacturers should expect to transition from national Croatian regulations to EU compliance requirements.
Of course, European commmisioners are in the middle of overhauling legislation for medical device market oversight.
Halmed won’t likely adopt full-blown MDD requirements until final changes to the Directives are established. Emergo Group will provide further details on Croatian and European market developments as we learn them.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
