Medical Devices Classification - This is an illustration of a hand under an x-ray. The hand shows the bones of the hand. This image is used by patient guard to demonstrate an example of a class IIb medical device.

Medical Device Classification EU

Blog, EU Regulations /

In the EU Medical Devices are categorised into 6 classes, these are Class I, Class Is (sterile), Class Im (measuring), Class IIa, Class IIb and Class III.  

Class I devices are considered to be of low risk, Class II devices as medium risk and Class III devices as high risk. 

Depending on the classification of device determines the regulatory conformity pathway that needs to be taken to gain compliance and allow manufacturers to place product on the EU market. 

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