​​​​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. 

Special types of medical devices: 

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? 

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. 

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. 

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. 

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