Medical Device Regulatory Requirements in Estonia
| Regulatory Authority |
Estonian Health Board |
| Regulatory Authority Website Link |
Click Here
|
| Device Classification |
I, IIa, IIb and III |
| Medical Device Regulations |
Medical Device Act
| Click Here
|
| IVD Classification |
A,B,C,D |
| In Vitro Diagnostics Regulations |
(EU) 2017/746
| Click Here
|
| Registration Process |
A short guide for using the Estonian Medical Device Database
| 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 Estonian Language |
| Database |
Database of medical devices and aids
| Click Here
|
| Additional Information |
The Health Board issues a free sale certificate for the export of a medical device to a manufacturer or authorized representative registered in Estonia upon request, which proves that the registered place of business of the manufacturer or authorized representative is in the Republic of Estonia and that the relevant medical device bearing the CE mark can be marketed in the European Union. |
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 We are not responsible for errors, omissions, or outdated content.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