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Lyfjastofnun Reglugerð

Reglugerð nr. 907/2022

Reglugerð um gildistöku reglugerða Evrópusambandsins um lækningatæki (Regulation on the entry into force of the European Union regulations on medical devices)
IcelandLyfjastofnunGeneralEffective 6 August 2022
What this code is

Reglugerð nr. 907/2022 is the official IMA identifier for “Reglugerð um gildistöku reglugerða Evrópusambandsins um lækningatæki (Regulation on the entry into force of the European Union regulations on medical devices)”. Reglugerð nr. 907/2022 is the official identifier IMA uses for this instrument.

Instrument
Reglugerð
Full name
Reglugerð nr. 907/2022
Category
General
Source links
Authority source
Icelandic
Issuing-authority publication; confirm whether a later amendment or consolidated version applies.
Readable HTML
2 articles · 1 language version
Direct citations can link to a specific article or section by appending its fragment identifier.
Dates
Published
5 August 2022
Effective
6 August 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.

About this regulation

Reglugerð um gildistöku reglugerða Evrópusambandsins um lækningatæki (Regulation on the entry into force of the European Union regulations on medical devices)

Reglugerð nr. 907/2022, made under Article 48(4) of lög nr. 132/2020 and first in force on 6 August 2022, on the entry into force in Iceland of the European Union regulations on medical devices. Two articles only, but the first is the operative incorporation provision: it is the Icelandic instrument that gives Regulations (EU) 2017/745 and (EU) 2017/746 effect in the Icelandic market, with the amendments to those regulations that the EEA Joint Committee has adopted. The instrument has been amended repeatedly as the EEA Joint Committee adopts further Union amendments; the island.is amendment history runs to reglugerð nr. 1096/2024 (2 October 2024) and nr. 1268/2025 (29 November 2025). It is ingested in full rather than as a reference from the Act because it is the provision a reader must cite to establish that the Union regulations apply in Iceland at all. The triage row's url was on reglugerd.is and its finalUrl on island.is; the finalUrl is recorded as the source and as the official document link.

Reglugerð nr. 907/2022 is the official identifier IMA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.