Law and regulation on Medical Devices

Act on Medical Devices 132/2020 (in Icelandic only)

MDR 745/2017

Regulation on in vitro medical devices No. 936/2011 and amendment No. 879/2012 (in icelandic only) valid until 26 May 2022.

IVDR 746/2017 valid from 26 May 2022

Regulation on instructions for use for medical devices intended to be used by the public 789/2021

Regulation on in vitro medical devices No. 936/2011 and amendment No. 879/2012 (in Icelandic only)

Regulations for reprocessing of single medical devices nr. 1154/2021

TARIFF No 1252/2020 for inspections and registration regarding medical devices (in Icelandic only)