Medical Device Regulatory Requirements in Iceland
| Regulatory Authority |
Icelandic Medicines Agency |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Laws and Regulations
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
(EU) 2017/746
| Click Here
|
| Registration Process |
Device Registration
| Click Here
|
| Registration Timeline |
There is no specific timeline mentioned for the registration of new medical devices in Iceland. |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Icelandic Language |
| Database |
EUDAMED
| Click Here
|
| Adverse Event Reporting Form |
Download |
| Additional Information |
Manufacturers of medical devices, importers and authorized representatives must, according to the regulation on medical devices, register in Eudamed. |
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.
The above information is last updated on 09/Apr/2025