So tying it all together, why would Canadians or other countries be concerned about #EUMDR? Well, the TL;DR is that smaller markets like Canada often share #MedicalDevice economies of scale by holding close or identical product offerings across #Regulatory jurisdictions. In Canada, our #MedTech regulator, #HealthCanada has #SignificantChange requirements which could be downstream of major markets like the European one. As a result, some companies must make difficult decisions in response to #MDR with unexpected downstream impacts, especially when it triggers retesting and refiling of submissions for legacy technologies. https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/guidance-document-interpretation-significant-change-medical-device.html