Post-Market Surveillance for SaMD

ByPiotr Wrzosinski

Staying Compliant Post-Launch

Post-market surveillance (PMS) is required for all devices.

Requirements:

  • Plan for data collection
  • Trend analysis and signal detection
  • Regular updates to clinical files
  • Vigilance reporting (e.g. EUDAMED)

For Class IIa+, submit PSUR every 1–2 years.

This post is part of SaMD Europe Launch Guide.

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Piotr Wrzosinski

Piotr Wrzosinski is a life sciences commercial and digital transformation leader with 20+ years of experience across pharma, medtech, and consulting. He writes about medtech, digital health, commercialization, AI, and regulation in Europe through an operator lens focused on adoption, evidence, and scale.