The enforcement date for the European Union (EU) Medical Device Regulation (EU 2017/745) (“MDR”) is quickly approaching. While the MDR entered into force on May 25, 2017, the three-year transition period ends on May 26, 2020. United States medical device manufacturers that do business in Europe must act fast to ensure compliance.[1] This blog provides […]
Tag: health care
The Health Care Entrepreneur’s Quick Guide to Important Laws: Part 2
Health Care Entrepreneurs need to know about the False Claims Act, Qui Tam Provisions and HIPAA. At a recent event, “Health Law 101: Key Legal Issues for Health Care Companies,” speakers identified the top five legal and regulatory issues for health care entrepreneurs to be aware of: The Anti-Kickback Statute, Stark Law, False Claims Act, […]