Croatia medical device regulations

Union instrument, expressed once in eu.ts as eu-regulation-2024-1860. This Croatian row is a metadata view onto that expression. It matters to Croatia on two of its three heads: the staged roll-out of EUDAMED, which decides when the Agency’s Article 7 registration check and single registration number become a mandatory route rather than a national one (Articles 1 and 2, and the new Article 34 and Article 78 provisions of the MDR), and the obligation on manufacturers to inform before interrupting or discontinuing supply, which reaches the Croatian market through the same distributors the Agency keeps a register of. It is not a second corpus copy.

The scale of fees the Agency charges for the services it performs, published as the currently valid Cjenik usluga HALMED-a, in force from 9 March 2024 with the amendments in force from 1 July 2024 and from 1 April 2025 incorporated. It is issued under Article 28 of the Zakon o provedbi Uredbe (EU) 2017/745 i 2017/746, which leaves the fees for the activities laid down by the two Regulations to a decision of the minister, and the published page records the three consents behind it: the Minister of Health’s letters of 29 February 2024, 17 May 2024 and 13 March 2025 (KLASA 530-09/24-04/04 and 530-09/25-04/07) and the Minister of Agriculture’s determination for the veterinary-medicinal products. It runs to thirteen numbered groups, in the publisher’s own numbering, of which group 8 Medicinski proizvodi is the device schedule: registration and refusal of registration in the register of manufacturers and authorised representatives (700 €, amendment 200 €); registration of devices in the register of medical devices by band (800 € for 1 to 5 devices, 900 € for 6 to 30, 1,000 € for more than 30); amendment of a device registration (300 €, or 200 € where the registration decision itself is unchanged); risk-class classification of a device and classification of a product into a device group on the manufacturer’s request (1,000 € plus the cost of an external expert where one is engaged); the annual maintenance of device status for manufacturers and authorised representatives established in Croatia (200 € up to 10 devices, 250 € for 11 to 40, 300 € for 41 to 70, 350 € for 71 to 150, and by further band above that); and items 10 to 19, which the group’s own footnote states begin to be charged under Articles 29 and 30 of Regulation (EU) 2017/745, the obligation to register devices and economic operators in EUDAMED. Group 13 (scientific opinion on a substance with an ancillary action) and group 10 (clinical investigations) are also device-relevant. The page is the instrument itself, not a page about it: the introductory paragraphs fix which version is in force and the ministerial consents behind it, and the numbered groups are its own structural unit, so the whole cjenik is ingested and segmented that way rather than only the device group.

Croatia is an EU member State, so Regulation (EU) 2017/746 applies directly and the same Croatian act implements it alongside the MDR — there is no separate Croatian IVD instrument, and Article 6 of the act gives the ministry the approval and supervision of IVD performance studies while Article 7 gives the Agency the Article 54 IVDR derogation decisions and the Article 55 IVDR free-sale certificates. The text is expressed once in eu.ts as eu-ivdr-2017-746; this row is the Croatian metadata view onto it and opens the articles the national layer applies: manufacturer obligations (Art. 10), the authorised representative (Art. 11), importer and distributor obligations (Arts. 13 and 14), the EUDAMED registration and the summary of safety and performance (Arts. 27 to 29) and the derogation from the conformity assessment procedures (Art. 54). It is not a second corpus copy.

Croatia is an EU member State, so Regulation (EU) 2017/745 applies directly and sits above the Zakon o provedbi Uredbe (EU) 2017/745 i 2017/746, which supplies the Croatian institutional layer the Regulation leaves to member States. The text is expressed once in eu.ts as eu-mdr-2017-745; this row is the Croatian metadata view onto it and opens the articles the national layer hangs off: manufacturer obligations (Art. 10), importer and distributor obligations (Arts. 13 and 14), the device and economic-operator registration duties (Arts. 29 and 30), under which the HALMED cjenik’s group 8 services 10 to 19 become chargeable, and clinical investigations (Art. 62), EUDAMED registration behind Article 7 of the act, which gives the Agency the economic-operator check and the single registration number (Arts. 30 and 31), the derogation from the conformity assessment procedures, which Article 14 of the act mirrors nationally by letting the Agency authorise a device with the consent of the minister (Art. 59), vigilance, which Article 7 of the act assigns to the Agency (Art. 87), and the transitional provision the certificates in circulation are read against (Art. 120). It is not a second corpus copy.

Zakon o provedbi Uredbe (EU) 2017/745 o medicinskim proizvodima i Uredbe (EU) 2017/746 o in vitro dijagnostičkim medicinskim proizvodima, promulgated by the President of the Republic on 5 November 2018 after the Hrvatski sabor adopted it on 31 October 2018 (Klasa 011-01/18-01/125), published in Narodne novine 100/2018 as document 1930 and in force from 22 November 2018 under its own Article 34 (the eighth day after publication). Croatia is an EU member State, so this act does not transpose the two Regulations — it implements them, which is why every substantive duty is read out of `eu.ts` and this text supplies the Croatian institutional layer. In ten chapters and 34 articles: general provisions, which declare the subject-matter (Chapter I); the competent authorities (Chapter II), where Article 5 names the ministry responsible for health and the Agencija za lijekove i medicinske proizvode (HALMED) as the two competent authorities, Article 6 assigns the ministry the approval and supervision of clinical investigations of devices and performance studies of IVDs, the designation, notification and monitoring of conformity assessment bodies, and Article 7 assigns the Agency the EUDAMED economic-operator registration check and the issue of the single registration number, the resolution of classification disputes between manufacturers and notified bodies, the register of distributors, the Article 59 MDR / Article 54 IVDR derogation decisions, free-sale certificates under Article 60 MDR / Article 55 IVDR, vigilance and the register of distributors, while Article 20(2) places market surveillance with the ministry’s pharmaceutical inspection; notified bodies (Chapter III); placing devices and IVDs on the market (Chapter IV), which carries the national notification duties and, at Article 14, the Agency’s power to authorise a device with the consent of the minister where the conformity assessment procedures have not been carried out — the national reflection of Article 59 MDR; clinical evaluation and clinical investigations (Chapter V); vigilance (Chapter VI); supervision (Chapter VII); procedural provisions (Chapter VIII), including Article 28, which provides that the fees for the activities laid down by the Regulations are set by a decision of the minister — the provision the HALMED Cjenik usluga is issued under; the prekršajne (misdemeanour) provisions (Chapter IX); and transitional and final provisions (Chapter X). Ingested from the Narodne novine HTML of NN 100/2018-1930.

Union instrument, expressed once in eu.ts as eu-regulation-2023-607. This Croatian row is a metadata view onto that expression. It matters to Croatia because the transitional periods it set for devices covered by a valid Directive 90/385/EEC or 93/42/EEC certificate (Article 120(3a) to (3f) MDR), and the corresponding IVDR period in Article 110(4), decide how long those certificates remain a route into the Croatian market — and because the Croatian act’s own register of devices, its annual maintenance fees and the Agency’s vigilance duties all run on the certificates in circulation rather than on the Regulation’s own conformity assessment. It is not a second corpus copy.