Vigilance - Are There New Reporting Requirements? How is the New Market Surveillance Being Applied?

The new Medical Device Regulation distinguishes between incidents and serious incidents. What is now reportable with the authorities?  Do we submit incident reports or can we still apply the guideline conditions where reporting under the medical device vigilance system is not usually required? The evaluations a manufacturer and the authorities must apply in case of a serious incident increases!  

NEW: How will affect the new Regulation (EU) 2019/1020 effect your Vigilance activities?