Medicines Authority RegulationRegulation (EU) 2017/745
Regulation (EU) 2017/745 is the official MMA identifier for “Medical Devices Regulation (MDR) as it applies in Malta”. Regulation (EU) 2017/745 is the official identifier MMA 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
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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.
Medical Devices Regulation (MDR) as it applies in Malta
Malta is an EU member State, so Regulation (EU) 2017/745 applies directly and sits above S.L. 458.59, which designates the Medicines Authority as competent authority and carries the national market-notification, registered-person and complaint-forwarding duties, with the Authority’s GL-MDF and GL-MDS notes as the application surface. The text is expressed once in eu.ts as eu-mdr-2017-745; this row is the Maltese 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 EUDAMED registration behind the organisation-registration and device-notification notes (Arts. 30 and 31, Art. 30(2) being the provision that lets Malta keep a national notification step), the derogation from the conformity assessment procedures that GL-MDF19/02 and the L.N. 254 of 2025 fee schedule are built around (Art. 59), vigilance (Art. 87) and the transitional provision the Authority’s own factsheet cites as the basis for the continuing registration of economic operators and devices (Art. 120(3)). It is not a second corpus copy.
Regulation (EU) 2017/745 is the official identifier MMA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.