Hi All,

I would agree that devices would be easier to get approved in the EU for a number of reasons. The main reason being that the classification is purely based on a checklist and risk. This allows a device to be designed and the company to know exactly how the device will be classified and they can simply follow those regulations. In the USA, this process is quite a bit more difficult as the class system can vary quite a bit more, making it more difficult to know exactly how a device will be classified. This is due to the classification system depending on more than simply just risk.
Looking forward to hear what others think and their experiences.

-Andrew Nashed