Lyfjastofnun ReglugerðReglugerð nr. 630/2022
Reglugerð nr. 630/2022 is the official IMA identifier for “Reglugerð um notkunarleiðbeiningar sem fylgja lækningatækjum (Regulation on instructions for use accompanying medical devices)”. Reglugerð nr. 630/2022 is the official identifier IMA uses for this instrument.
- Instrument
- Reglugerð
- Full name
- Reglugerð nr. 630/2022
- Category
- Labeling
- Authority source
- Icelandic
- Readable HTML
- 10 articles · 1 language version
- Published
- 31 May 2022
- Effective
- 1 June 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.
Reglugerð um notkunarleiðbeiningar sem fylgja lækningatækjum (Regulation on instructions for use accompanying medical devices)
Reglugerð nr. 630/2022, made under Article 12(4) and Article 48(4) of lög nr. 132/2020 and first in force on 1 June 2022, on the instructions for use that accompany medical devices. It states the Icelandic language requirements for instructions supplied with a device and the conditions under which electronic instructions for use may be provided instead of paper, for professional users and for lay users, together with the manufacturer's duties where electronic instructions are offered and the information that must still be delivered with the device itself. Ten articles are ingested: gildissvið, skilgreiningar, tungumálakröfur, the two electronic-instruction provisions, the manufacturer's duties, the information supplied with the device, eftirlit og viðurlög, innleiðing and gildistaka. The island.is page renders the fourth and fifth articles twice, once as `4.gr.`/`5.gr.` and again as `4.gr.__2`/`5.gr.__2`, with different titles and different text; that is a rendering artefact of the regulation collection's consolidation view, not a repetition in the instrument, and all ten headings are ingested in printed order under unique ids (`gr-4-2`, `gr-5-2` for the second pair).
Reglugerð nr. 630/2022 is the official identifier IMA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.