Classification of a Class IIb Medical Device with 3 Components

[HeatherC-S]

My company will be a legal manufacturer a medical device. Overall it is classified as a IIb.

However, there are three components to it.
1. A generator which delivers a specific type of power to the device
2. A grounding pad which is placed on to the patient (sterile), this is connected to the generator
3. A probe which is the invasive part to the patient, but is only used <1 hour (sterile), this is connected to the generator

The three components will be manufactured by three different companies. Therefore how does the classification work in this instance?

Many thanks

Heather

 

[Marcelo]

You need to defined what is the device, and which are accessories, if any. Then you need the identify the risk class or classes that are applicable, and use the worst class.

The fact that they are manufactured separately does not have any influence on the risk classification.