Inform NB of change to Indications of Use, but change is not a medical feature

Asherlee

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A Class IIa medical device has two medical features approved by the NB for CE marking. The manufacturer now wants to add a new feature to the device, but is claiming that the new feature has a wellness function only and does not fall within the definition of a medical device as set out in the MDD or MDR.

So while the new feature is a "substantial"change since it changes the spec. of the device and the Indications for Use for the device, the new feature is not intended to have a medical function (this claim is supported by the labeling).

Question: does the manufacturer have to inform the NB of the new/wellness feature?

Thanks

Asherlee
 
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