Medical Device Registration

Registration of distributors

According to the Icelandic law on medical devices, distributors of medical devices who are responsible for the marketing of such devices in Iceland must register with The Icelandic Medicines Agency, IMA.

The appropriate form is downloaded from IMA‘s website, filled out and sent to the email address: [email protected]

IMA does not maintain registation of medical devices.

Registration of manufacturers

Manufacturers of medical devices, importers and authorized representatives must, according to the regulation on medical devices, register in Eudamed.

Operators are encouraged to contact their national competent authority on how to register in Eudamed.