Yes it can be Class IIb as per Rule 9 if it was intended to be used for continuous surveillance of vital physiological processes in anaesthesia, intensive care or emergency care.
But in this case the BP to which this hub is attached obtain readings of vital physiological signals in routine check ups and in self-monitoring and thus BP in this case is Class IIa. So I understand as the system (hub and BP) the classiffication would be Class IIa but for the hub alone what classficatuion makes sense. The intended use of the hub being acknowledging, storing and tranfering the readings from BP moniotr to the web server where a clinician can read. The hub does not alter any data as such.
Going by your explanation, it does not fit into active medical device ? Can we agree on this ?
If this is the case then the rules open are 1,2,3,4.
Then by rule 1 it must fall into class I.
Remember this :
- Accessories are classified in their own right separately from the device with which they are used
- If a given device can be classified according to several rules, then the highest possible class applies.
How are your competators on this classification ?
Since we are brainstorming ... Have you first decided
if the product concerned is a medical device as defined in Directive 93/42/EEC or an accessory to such a medical device, if it is not excluded from the scope of this Directive and if it therefore comes within the scope of this Directive.