HALMED RegulationRegulation (EU) 2017/746
Regulation (EU) 2017/746 is the official HALMED identifier for “In Vitro Diagnostic Medical Devices Regulation (IVDR) as it applies in Croatia”. Regulation (EU) 2017/746 is the official identifier HALMED uses for this instrument.
- Instrument
- Regulation
- Full name
- Regulation (EU) 2017/746
- Category
- Registration
- Authority source
- English
- Readable HTML
- Section view of Regulation (EU) 2017/746
- Published
- May 5, 2017
- Effective
- May 26, 2022
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.
In Vitro Diagnostic Medical Devices Regulation (IVDR) as it applies in Croatia
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.
Regulation (EU) 2017/746 is the official identifier HALMED uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.