A
Asherlee
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
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