The product in question consists of a wearable soft patch and a smart device app to display the data it transmits. The MDR defines an accessory as an article whilest not being part of a medical device is intended by its manufacturer to be used together with one or several particular medical devices to enable the device to meet its intended purpose.
Would all iPhones and Galaxy phones capable of running our Software be considered to be an accessory?
This would require us to have a design file for each model phone and each phone listed in our DoC?
Would all iPhones and Galaxy phones capable of running our Software be considered to be an accessory?
This would require us to have a design file for each model phone and each phone listed in our DoC?