The regulatory grey zone for digital health in the European Union has finally cleared. In a landmark move, the EU's Medical Device Coordination Group (MDCG) has issued the MDCG 2025-4 Guidance, a document that fundamentally reshapes the responsibilities for medical device software (MDSW) and Software as a Medical Device (SaMD) distributed through major online platforms.

MDCG 2025-4  Medical Device Software Apps on Online Platforms

The FDA's new Computer Software Assurance (CSA) guidance marks a pivotal shift for the medical device industry, moving away from the rigid, documentation-heavy Computer System Validation (CSV) that has historically slowed innovation and the adoption of modern digital tools like eQMS. This new framework introduces a risk-based, critical-thinking approach designed to reverse the traditional 80/20 effort from documentation to value-added assurance activities. By classifying software functions into a simple binary of "high process risk" versus "not high process risk," CSA allows manufacturers to tailor their validation efforts, applying rigorous scripted testing only where a failure could foreseeably impact patient safety, while using more flexible and efficient unscripted methods for lower-risk functions. This change not only streamlines the validation of automated systems and clarifies the path for cloud-based platforms but also fundamentally reshapes the relationship with software suppliers, creating a "leverage economy" where vendor assurance packages become a critical component of a manufacturer's compliance strategy, ultimately fostering faster innovation, greater efficiency, and a stronger focus on product quality and patient safety.

CSV to CSA: How the FDA's New Software Assurance Guidance Ends MedTech's Validation Gridlock and Unleashes Innovation

Miloš Cigoj

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