Medicines Authority RegulationRegulation (EU) 2017/746
Regulation (EU) 2017/746 is the official MMA identifier for “In Vitro Diagnostic Medical Devices Regulation (IVDR) as it applies in Malta”. Regulation (EU) 2017/746 is the official identifier MMA 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
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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 Malta
Malta is an EU member State, so Regulation (EU) 2017/746 applies directly; as with the MDR there is no Maltese instrument restating it, and the national layer is the same S.L. 458.59 and GL-MDF/GL-MDS notes, which are written to cover in-vitro diagnostic devices alongside medical devices. The text is expressed once in eu.ts as eu-ivdr-2017-746; this row is the Maltese metadata view onto it and opens the articles those documents apply: 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 that GL-MDF19/02 and the L.N. 254 of 2025 fee schedule administer for IVDs (Art. 54). It is not a second corpus copy.
Regulation (EU) 2017/746 is the official identifier MMA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.