Medical Device Registration in


Ministry of Health

The Ministry of Health and Care Services (HOD)

Regulatory Authority

Norwegian Medicines Agency

Medical Device Regulation

EU MDR 2017/745

Official Language

Norwegian, Sámi


Class I, IIa, IIb and III

Medical Device Registration in Norway

  • Determine the device classification.
  • Appoint an Authorized Representative and Notified Body.
  • Have systems for risk management and quality management (QMS).
  • Compile technical documentation and apply for conformity assessment procedure.
  • For some implantable devices; provide an implant card for the patient
  • Once approved, prepare a declaration of conformity and apply CE marking to their devices

Documents Required

  • Application Form
  • Product Description
  • Technical File
  • CE certificate and the Declaration of Conformity
  • QMS Certificate
  • A copy of the label/instructions for use

Post-market Requirements

Serious public health threats – 2 day

Death or serious health deterioration – 10 days

Other serious incidents – 15 days

Applicable QMS

ISO 13485:2016

Registration Timeline

Class I: 4-6 weeks

Others: Based on Notified Body timeline

Authorized Representative


License Validity

5 years

Special Notes

Norwegian labelling and IFU

Want to know more about this registration process?