EMERGO BY UL SUMMARY OF KEY POINTS: The European Medical Devices Regulation (MDR) will tie post-market clinical follow-up (PMCF) data more closely to post-market surveillance and clinical evaluation report requirements. Medical device companies’ PMCF studies will have to include specific components identified in the MDR. Approvals for PMCF studies will need to be obtained by Ethics Committees and, in some cases, Competent Authorities.