Medical Device Regulatory Requirements in Finland
| Regulatory Authority |
Finnish Medicines Agency |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
EUMDR-2017/745
| 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 |
For Class I, it is 1 to 2 months and for other classes, it depends on the notified body and type of product |
| Requirement of Authorized Representative |
Yes |
| Language Requirement |
Labels must be in Finnish and Swedish Language |
| Database |
EUDAMED
| Click Here
|
| Adverse Event Reporting Form |
Download |
| Additional Information |
There are two registers for registering medical device information: the national CERE register maintained by Fimea and the Eudamed register maintained by the European Commission. |
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 We are not responsible for errors, omissions, or outdated content.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