Medical Device Registration in
Ministry of Health
Medical Device Regulation
EU MDR 2017/745
Medical Devices Act (No. 98/09)
Class I, IIa, IIb and III
- Determine the device classification
- Appoint Authorized Representative and Notified Body
- Class I device can be Self-Certified. QMS necessary but Notified Body intervention is not required.
- For other classes, prepare a CE Technical File
- Obtain and register UDI in EUDAMED.
- Technical File should be audited by Notified Body.
- Once approved, prepare a Declaration of Conformity.
- The device can now be marketed in Slovenia
- CE Certificate
- Declaration of Conformity
- Technical File
- QMS Certificate
- Risk Management Plan
- IFUs, Label or User Manual
- Clinical Studies Report
- Postmarket Surveillance Plan
- Serious public health threats – 2 day
- Death or serious health deterioration – 10 days
- Other serious incidents – 15 days
Class I – 4-6 weeks
Others – Depending on the timeline by Notified Body
IFUs or Labels should be in Slovenian or English