The MDR(EU) 2017/745 on Medical Devices introduced several new features and added stricter requirements than in the previous directives, which is why it is not sufficient to simply readjust existing documentation. Consequently, the first step in the process of compliance with MDR (EU) 2017/745 requires precisely planning the actions to be pursued to close the gap, through a strategic approach.
Generally speaking, compared to the previous regulation, the timeframe of the compliance process has lengthened.