EMERGO BY UL SUMMARY OF KEY POINTS: The European GDPR has ramifications for how medical device human factors researchers collect and manage data related to study participants, even outside of the EU. Human factors researchers should work with their clients (if they serve in a consulting capacity) and other third parties (e.g., vendors) to define roles and responsibilities early during study planning and develop best practices that comply with GDPR requirements. All participant data management decisions and rationales should be properly documented to demonstrate GDPR compliance.