Hi, please help me on the below confusion:
If a medical device manufacturer buys an OTS device (not intended as a medical device) and delivers to the user together with his other CE marked devices, will it be considered as "systems and procedure packs" category? Please note that there are no label changes done on the OTS. It is just for ease of customer, instead of themselves ordering directly from the OTS manufacturer we deliver as one complete set with our devices.
Meantime compatibility between the devices is verified and validated. Thanks.
If a medical device manufacturer buys an OTS device (not intended as a medical device) and delivers to the user together with his other CE marked devices, will it be considered as "systems and procedure packs" category? Please note that there are no label changes done on the OTS. It is just for ease of customer, instead of themselves ordering directly from the OTS manufacturer we deliver as one complete set with our devices.
Meantime compatibility between the devices is verified and validated. Thanks.