Ministry of Health

Ministry of Health

Regulatory Authority

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP)

Medical Device Regulation

EU MDR 2017/745

Medical Devices Act (No. 98/09)

Official Language

Slovene

Classification

Class I, IIa, IIb and III

Medical Device Registration in Slovenia

• 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

Documents Required

• CE Certificate
• Declaration of Conformity
• Technical File
• QMS Certificate
• Risk Management Plan
• IFUs, Label or User Manual
• Clinical Studies Report
• Postmarket Surveillance Plan

Post-market Requirements

• Serious public health threats – 2 day
• Death or serious health deterioration – 10 days
• Other serious incidents – 15 days

Applicable QMS

ISO 13485

Registration Timeline

Class I – 4-6 weeks

Others – Depending on the timeline by Notified Body

Authorized Representative

Yes

License Validity

5 years

Special Notes

IFUs or Labels should be in Slovenian or English