Equivalence within Medical Device Family

Harini17

Involved In Discussions
#1
Dear experts,
Can we claim equivalency within the family of devices of the same manufacturer? Is it acceptable as per Meddev rev4 and MDR?

The equivalent device will also be our device under evaluation covered under scope. To how far is it right? Do we have any other approach?

Looking forward to hear from you

Thanks in advance
 
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BhupinderSinghPawa

Involved In Discussions
#2
You can demonstrate equivalence to an existing CE marked equivalent device - whether it is from same manufacturer or a different manufacturer - should not matter; thought it is not specifically stated. You can use the corresponding clinical data of the equivalent device in the new device's CER. In a way, you are better off doing equivalence comparison as you have full access to the equivalent device Technical File. In fact, it is a good strategy for multiple generations of the device family evolution in the market.

If the device is not CE marked, then justifications for use of clinical data will need to be provided.
 
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