Edwards Lifesciences Corp (EW) Risk Factors

Recent key developments

Concrete developments — dated events, named agreements and instruments, legal proceedings — that Edwards Lifesciences Corp surfaced in its latest filing.

• On September 3, 2024, we sold our Critical Care product group to Becton, Dickinson and Company.September 3, 2024
• The U.S. Department of Commerce recently initiated an investigation under Section 232 of the Trade Expansion Act of 1962 into imports of personal protective equipment, medical consumables and medical equipment (including devices) to determine whether they threaten U.S. national security.
• The U.S. government has imposed, modified and paused tariffs multiple times since the beginning of 2025.2025
• A Mutual Recognition Agreement still under negotiation for the Medical Device Regulation may result in a lack of free movement of medical devices between the EU and Switzerland.
• The EU Medical Device Regulation (MDR) came into effect in May 2017 and became applicable in May 2021 with a staggered transition period.May 2017
• The United States federal government shut down on October 1, 2025, causing the FDA to furlough critical employees and stop critical activities.October 1, 2025
• Many countries are aligning their international tax rules with the OECD's Base Erosion and Profit Shifting Pillar Two recommendations.