For nearly 30 years, the U.S. Food and Drug Administration has played a pivotal role in shaping the global medical device industry through strict regulatory requirements, international cooperation, and adaptation to technological advancements. However, with significant changes on the horizon in the U.S., how will these developments affect medical device manufacturers in Europe?
The United States remains a crucial market for European medical device manufacturers. As the world’s largest medical device market, it offers significant opportunities for European companies seeking global expansion. Additionally, the complexity of the EU Medical Device Regulation has prompted some non-European manufacturers to prioritize the U.S. as their preferred market for growth.
In recent years, the FDA has made substantial investments to enhance regulatory efficiency and accelerate market access. Programs such as E-Star, the Breakthrough Devices Program, and the Total Product Life Cycle (TPLC) Advisory Program facilitate early engagement and prioritized review for innovative technologies. Furthermore, increased staffing and funding through the Medical Device User Fee Amendments (MDUFA) have strengthened the FDA’s review processes, ensuring a more efficient and timely approval pathway.
As of February 2025, President Donald Trump’s administration has proposed significant reforms to the FDA. The nomination of Robert F. Kennedy Jr. as Secretary of Health and Human Services (HHS) signals a potential shift in the agency’s regulatory approach and priorities. Additionally, the administration is considering an executive order that could significantly reduce the FDA’s workforce. The administration has also indicated plans to streamline FDA ´s regulatory processes to accelerate the approval of innovative medical devices. Proposed measures include reducing bureaucratic obstacles. Specific details on the implementation of these changes have, however, not yet been fully outlined.
The current uncertainties surrounding potential FDA regulatory changes under the Trump administration create challenges for EU medical device manufacturers seeking U.S. market entry. A faster, less stringent approval process could lower barriers to entry, but shifting FDA policies may create unpredictability in compliance expectations, making it harder for EU manufacturers to align their regulatory processes. This regulatory uncertainty can affect investment decisions and long-term planning for companies looking to expand into the U.S. market.
The future development of the regulatory landscape in the U.S. remains uncertain and needs to be closely monitored by manufacturers intending to enter U.S. At QAdvis, our Quality and Regulatory consultancy team tracks these developments to support our customers and provide a proactive approach to upcoming changes. Or, to paraphrase Charles Darwin; The one most responsive to change is the one most likely to survive.
