To Go Thru The CER Simple Route And Compare With The Equivalent Device In Terms Of Clinical Data, What Resources Is Available To Get Equivalent Devices ’clinical Report?

If you are using for own device as equivalent device, you definitely have the access to the clinical report. If you use competitor’s device, you will need to find their publicly available resources. In the new technical guidance, the requirement of comparing manufacturing processes is gone and this is good news for us.