Advertising rules for medical devices in Croatia
Advertising of medical devices in Croatia is governed by Articles 59 and 60 of the Zakon o medicinskim proizvodima (NN 76/13). Article 59(1) defines advertising of a medical device as any form of communication whose purpose is to encourage the prescribing, sale or consumption of devices, in written, oral, pictorial, sound, electronic, digital or other form. Advertising a device that does not meet the conditions prescribed by the Act is prohibited, except for devices intended for exhibitions, demonstrations and fairs and the like, which must carry a visible marking that they are not intended to be placed on the market or put into service (Art. 59(2)); misleading advertising of a medical device is prohibited (Art. 59(3)); and devices intended exclusively for the performance of health-care activity may be advertised only to health professionals (Art. 59(4)). Article 60 lists the content that device advertising must not contain: impressions that the device guarantees success in treatment or that the patient's health can improve only through the advertised device; impressions that health would worsen without it; encouragement to abandon basic generally accepted therapeutic procedures; material directed exclusively or predominantly at children; confusing use of scientific expressions unknown to the general public; appeals to statements by scientists, health professionals or other publicly influential persons; the claim that a product is safe merely because it is of natural origin; detailed descriptions of a pathological state that could lead to self-diagnosis; inappropriate, disturbing or misleading statements about recovery prospects; inappropriate, disturbing or misleading images of disease-induced changes to the human body; and material that endangers human dignity. This national layer sits on top of the Union rule: MDR Article 7 prohibits misleading text, names, trademarks, pictures and figurative or other signs in labelling, instructions for use, making available, putting into service and advertising, and Croatia penalises breach of Article 7 points (a) to (d) in advertising under Article 32(1) points 2 to 5 of the Zakon o provedbi Uredbe (EU) 2017/745 i Uredbe (EU) 2017/746 (NN 100/2018) with a fine of HRK 50,000 to 200,000.
- The Union layer is MDR Article 7, which applies directly in Croatia as a Member State; the national Act adds its own definition of advertising, its own prohibition on advertising non-compliant devices (with the trade-fair carve-out), its own misleading-advertising prohibition and the health-professional-only rule for devices intended exclusively for health-care activity.
- Breach of MDR Article 7 points (a)-(d) in advertising is an administrative offence under Article 32(1) points 2-5 of NN 100/2018 (fine HRK 50,000-200,000 for a legal person; HRK 10,000-60,000 for a sole trader; HRK 5,000-8,000 for the responsible person), and the Croatian-language information duty is separately penalised under point 8 of the same provision together with Article 30 of NN 100/2018.
- The text read is the Zakon o medicinskim proizvodima as published in Narodne novine No. 76 of 21 June 2013 (document no. 1521); the gazette page is the instrument as published, not a consolidated text with later amendments.
Effective from 2013-07-01
Croatian. Verbatim from the gazette text (Art. 59): "Pod oglašavanjem o medicinskom proizvodu u smislu ovoga Zakona podrazumijeva se svaki oblik obavješćivanja kojemu je namjena poticanje njihova propisivanja, prodaje i potrošnje u pisanom, usmenom, slikovnom, zvučnom, elektroničkom, digitalnom ili drugom obliku." / "Zabranjeno je oglašavanje o medicinskom proizvodu koji ne ispunjava uvjete propisane ovim Zakonom, osim za medicinske proizvode namijenjene za izložbe, demonstracije, sajmove i sl. Takvi proizvodi moraju imati vidljivu oznaku da nisu namijenjeni stavljanju u promet niti stavljanju u uporabu." / "Zabranjeno je zavaravajuće oglašavanje o medicinskom proizvodu." / "Medicinski proizvodi koji su namijenjeni uporabi isključivo za obavljanje zdravstvene djelatnosti smiju se oglašavati isključivo prema zdravstvenim radnicima." English: "Advertising of a medical device within the meaning of this Act means any form of communication the purpose of which is to encourage their prescribing, sale and consumption in written, oral, pictorial, sound, electronic, digital or other form." / "Advertising of a medical device which does not fulfil the conditions prescribed by this Act is prohibited, except for medical devices intended for exhibitions, demonstrations, fairs etc. Such products must carry a visible marking that they are not intended for placing on the market or putting into use." / "Misleading advertising of a medical device is prohibited." / "Medical devices intended for use exclusively for the performance of health-care activity may be advertised only to health professionals." Art. 60 verbatim opening: "Oglašavanje o medicinskim proizvodima ne smije sadržavati podatke koji: – ostavljaju dojam da medicinski proizvod jamči uspjeh u liječenju bolesti te da se zdravlje pacijenta može poboljšati isključivo korištenjem oglašavanog medicinskog proizvoda, a objektivne tvrdnje moraju biti potkrijepljene dokazima, – ostavljaju dojam da bi se zdravlje pacijenta moglo pogoršati izostankom uporabe oglašavanog medicinskog proizvoda, – potiču na odustajanje od osnovnih općeprihvaćenih terapijskih postupaka …" (the list continues through eleven indents ending "– ugrožavaju ljudsko dostojanstvo."). This row replaces the round-204 version, which rested on the HALMED guidance page and was graded source-backed-partial for that reason; the same key is reused so the importer refreshes it in place. HALMED's page — retrieved again on 2026-09-16 and kept as a supporting source — states "Oglašavanje medicinskih proizvoda propisano je člancima 59. i 60. Zakona o medicinskim proizvodima (Narodne novine, br. 76/13.).", i.e. the agency itself points to the articles now read directly. The gazette page also carries the agency-fee article (Art. 58: annual fee for the register of manufacturers, the retail authorisation and the register of wholesalers), which is not part of this fact.
