How to place a medical device on the market

​​​​Is the device a medical device, what type of medical device is it, and what risk class does it belong to?

The risk class and type of medical device determine the requirements for a medical device. Here you will find guidance on the definition of a medical device and how to determine the proper risk class for your medical device. In addition, a more detailed description of the different groups and special types of medical devices is presented. 

• ​Is the device a medical device?
  
• What risk class does the device belong to? (in Norwegian) 
  

Special types of medical devices: 

• ​Custom-made devices
  
• Systems and procedure packs
  
• Medical devices manufactured In-house​ (in Norwegian)
  
• Parts and components that do not change the performance or intended purpose
  
• Devices for special purposes
  

Which type of market operator role do you have?

As a medical device economic operator, you as a company, have to clarify your own role. Do you have one or more roles? Manufacturer, authorized representative, importer, distributor, procurer and/or user? 

• ​Different roles for economic operators​
  
• Cases in which obligations of manufacturers apply to importers, distributors or other persons
  

What does the development of a medical device involve?

It is important to have a thorough understanding of the requirements set for a medical device from the moment an idea is developed, until the device is conformity assessed and CE-marked. 

• ​Person Responsible for Regulatory Compliance (PRRC)​
  
• Quality management system and risk management​
  
• Harmonised standards
  
• Information supplied with the device (labelling and instructions for use)
  
• Language requirement
  
• Implant card
  
• Clinical trial
  
• Performance studies​
  
• Traceability (UDI)
  
• Advertising
  

How to proceed with the conformity assessment procedure, CE marking and registration of medical devices?

Here you will find information regarding the processes that must be completed before a medical device can be placed on the market. 

• ​Conformity Assessment procedure (in Norwegian) 
• Notified body (certificate of conformity, article 56)
  
• Declaration of Conformity
  
• CE marking of conformity
  
• Registration​
  

Do medical devices require follow-up after being placed on the market?

The processes involving development, conformity assessment and CE marking shall ensure that the device is safe to use. However, adverse events, device deficiencies and serious incidents may still occur during the use of the device, and the manufacturers must therefore monitor and follow-up the device even after it is CE marked. 

• ​Monitoring of medical devices after placement on the market​ (in Norwegian)