Classification, qualification, and other changes to Software as a Medical Device (SaMD) under the new European Medical Device Regulation (EU MDR) continue to create angst and uncertainty. In this episode, Andrew Wu and I discuss the ramifications of these changes. Andrew is a software consultant with Rook Quality Systems and software as a medical device (SaMD) expert. Some of the highlights of the show include: ● Most noticeable change is a broader definition of what qualifies as a medical device to include prediction and prognosis of diseased state. ● SaMD classification changes are drastic but vague following MDR implementation. ● Gap analysis should be performed to identify changes that companies need to make to conform with changes. ● Groups that will most likely experience the greatest impact due to classification and qualification changes: ○ Products on market in EU as Class I software will be uplisted as Class IIa. ○ Products that provide clinical information for informed clinical decisions. ● Timeline and Some Next Steps: Demonstrate conformance, update quality management system (QMS), notify regulatory body to MDR by May 25, 2020. ● Plan, prioritize, and understand your regulatory conformance strategy going forward. ● Compare and Contrast EU MDR and US FDA: Developing regulatory framework in different directions, but share consensus on sensitive nature and usage.