Choosing between the US and EU markets for your LED phototherapy device is one of the most critical strategic decisions you will make. While pre-market clearance or certification is a major hurdle, the long-term operational costs and risks are defined by post-market obligations. Understanding the fundamental differences in US vs EU medical device regulations is not just a compliance exercise; it is essential for budgeting, risk management, and sustainable growth. This guide breaks down the two divergent philosophies on post-market surveillance and supply chain liability to help you build a resilient market entry strategy.