The Regulatory Reset: How Evolving Global Frameworks Are Redefining MedTech Innovation
The medical technology sector is currently undergoing a regulatory reboot as global regulators overhaul the rules for medical technology and digital health. New global regulatory frameworks, ranging from the EU’s MDR/IVDR overhauls to the FDA’s digital health strategies and the UK’s AI sandbox, are redefining the MedTech innovation landscape by striking a balance between patient…