NN 100/2018-1930

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.

NN 100/2018-1930 is the official identifier HALMED uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.