Lyfjastofnun LögLög nr. 132/2020
Lög nr. 132/2020 is the official IMA identifier for “Lög um lækningatæki (Act on Medical Devices)”. Lög nr. 132/2020 is the official identifier IMA uses for this instrument.
- Instrument
- Lög
- Full name
- Lög nr. 132/2020
- Category
- General
- Authority source
- Icelandic
- Readable HTML
- 50 articles · 1 language version
- Published
- 8 December 2020
- Effective
- 26 May 2021
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Lög um lækningatæki (Act on Medical Devices)
Lög um lækningatæki 2020 nr. 132, 8. desember, the Icelandic Act on medical devices, ingested as the consolidated Lagasafn text published by the Althingi. Eight chapters — objectives, incorporation and scope; definitions; overall direction and the role of Lyfjastofnun; the requirements devices must meet; the duties of economic operators; device identification and traceability, registration and related matters; supervision and sanctions; and regulations, entry into force and related provisions — with fifty articles. The Act took effect on 26 May 2021, the date the Union regulations on medical devices became applicable in the EEA, and the Lagasafn header states the EEA basis: Annexes I and II to Regulation 2017/745, Annex II to Regulation 2017/746, and Regulation 2020/561. It has since been amended by L. 69/2025, in force 12 November 2025, which adds the EEA reference to Annex II to Regulation 2022/123, and by L. 39/2026, in force 12 May 2026, which adds the EEA reference to Annex II to Regulation 2024/1860. The Act is enacted by the Althingi; Lyfjastofnun, the registry regulator, is the authority it charges with overall direction and supervision.
Lög nr. 132/2020 is the official identifier IMA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.