Law and regulation on Medical Devices

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

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

Regulation for transposition of EU regulation on medical devices nr. 627/2013  (in Icelandic only)

Regulation for transposition of EU regulation on medical devices (II) nr. 1296/2013  (in Icelandic only)

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