Iceland medical device regulations

Gjaldskrá nr. 1529, signed 17 December 2025 and published in the B-deild of Stjórnartíðindi on 30 December 2025, setting the fees for Lyfjastofnun's supervision of medical devices. It is made by Heilbrigðisráðuneytið (the Ministry of Health) under the authority of Article 39 of lög nr. 132/2020 and on proposals from Lyfjastofnun, and it took effect on 1 January 2026; at the same time it repeals the previous schedule, gjaldskrá nr. 1555/2023. Eleven numbered fee groups are ingested, covering certificates — including the free sale certificate and the certificate for an in-vitro diagnostic device, priced per copy above the first five — as well as registration, inspection, clinical investigation and other supervisory fees. The issuer is the Ministry and the proposing body is Lyfjastofnun; the registry regulator label is used for this row and the distinction is stated here.

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. 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).

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.