EU SaMD Regulations: Mastering App Store Compliance and 'Making Available' Rules

Medical Device Global Market Access · Feb 4, 2026 · 3m

This episode explores the critical new regulatory focus from Europe's Medical Device Coordination Group (MDCG) on Software as a Medical Device (SaMD) distributed via online platforms. We discuss how the concept of 'making available on the market' now directly applies to app stores, forcing manufacturers to integrate platform listings, version control, and geographic restrictions into their core compliance and Quality Management Systems to avoid significant penalties. Key Questions: - What does 'making available on the market' mean for a medical app? - How can your app store listing create a…