Law and regulation on Medical Devices

Act on Medical Devices No. 16/2001

Regulation on Medical Devices No. 934/2010

Regulation on active implanted medical devices No. 320/2011 (in Icelandic only)

Regulation on in vitro medical devices No. 936/2011 and amendment No. 879/2010 (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 545/2017 for inspections and registration regarding medical devices (in Icelandic only)