Medical Device Registration in
Norway
Ministry of Health
The Ministry of Health and Care Services (HOD)
Regulatory Authority
Medical Device Regulation
EU MDR 2017/745
Official Language
Norwegian, Sámi
Classification
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
Yes
License Validity
5 years
Special Notes
Norwegian labelling and IFU