Governed by the European Union Medical Device and IVD Regulations (EU 2017/745, 2017/746)
| 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 |
| 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. |