HALMED RegulationRegulation (EU) 2017/745
Regulation (EU) 2017/745 is the official HALMED identifier for “Medical Devices Regulation (MDR) as it applies in Croatia”. Regulation (EU) 2017/745 is the official identifier HALMED uses for this instrument.
- Instrument
- Regulation
- Full name
- Regulation (EU) 2017/745
- Category
- Registration
- Authority source
- English
- Readable HTML
- Section view of Regulation (EU) 2017/745
- Published
- May 5, 2017
- Effective
- May 26, 2021
Open a language version
Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Medical Devices Regulation (MDR) as it applies in Croatia
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.
Regulation (EU) 2017/745 is the official identifier HALMED uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.