This paper outlines the requirements specific to incident reporting, vigilance, mandatory problem reporting, medical device reports and adverse event reporting, herein termed ‘vigilance’, in comparison with the requirements of the recently published European Medical Device Regulation (MDR) to support those working with these aspects within the MDSAP Programme. Manufacturers who wish to supply their devices outside of these regions may have many more requirements to meet, the discussion of which is beyond the scope of this paper.
