The new EU Medical Device Regulation 2017/745 (MDR) requires companies to provide a periodic safety update report (PSUR) and a post market surveillance report (PMSR). Creating these reports will strengthen the post market surveillance and vigilance system of medical devices by improving quality and patient safety. The first compliance deadline 1 year after the date of application of the regulation is around the corner, but a guidance document on PSUR requirements has yet to be officially released. The guidance draft has been re-worked several times in the last few years, becoming a very lengthy document outlining more detailed and precise information on high-level points described in the MDR regulation, thus introducing more ambiguity in certain sections. It is quite evident that creating PSURs and PMSRs is not a small task and should not be underestimated by manu facturers. Companies should seriously consider investing in the automation of report authoring to reduce the cost of manually creating the PSUR and PMSR.