Medical Device Registration in
Ministry of Health
Medical Device Regulation
EU MDR 2017/745
Class I, IIa, IIb and III
- 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
- Application Form
- Product Description
- Technical File
- CE certificate and the Declaration of Conformity
- QMS Certificate
- A copy of the label/instructions for use
Serious public health threats – 2 day
Death or serious health deterioration – 10 days
Other serious incidents – 15 days
Class I: 4-6 weeks
Others: Based on Notified Body timeline
Norwegian labelling and IFU