Medical Device Registration in

Slovenia

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

Registration Process

  • 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

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