Medical Device Regulatory Requirements in Slovenia
| Regulatory Authority |
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia |
| 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 |
Medical 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 Slovene Language |
| Adverse Event Reporting Form |
Download |
| Additional Information |
The JAZMP can issue a manufacturer or an authorized representative established in the Republic of Slovenian a Certificate of Free Sale for their device that states that this manufacturer or authorized representative is established in the territory of the Republic of Slovenia and that its CE-marked device can be placed on the EU market. |
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 We are not responsible for errors, omissions, or outdated content.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