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Digital Health MedTech

Post-Market Surveillance for SaMD

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.

This content has been enhanced by GenAI tools.

By Piotr Wrzosinski

Piotr Wrzosinski is a Pharma and MedTech commercialization and digital marketing expert with 20+ years of experience across pharma (Roche, J&J), consulting (Accenture, IQVIA) and medical devices (BD).
He leads transformative EMEA Omnichannel Delivery Center team at Becton Dickinson and shares insights on Pharma, MedTech and Digital Health at disrupting.healthcare to speed up digital innovation in healthcare, because patients are waiting for it.

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