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)