SaMD Europe Launch Guide

Welcome to the definitive guide to launching Software as a Medical Device (SaMD) in Europe.

This 10-part series breaks down the complex regulatory, clinical, and commercial landscape for MedTech founders, investors, and digital health innovators navigating the EU market.

Explore the Series:

  1. What Is Software as a Medical Device (SaMD)?
  2. Rule 11 Explained: Classifying SaMD in the EU
  3. Building a Compliant QMS for SaMD
  4. Cybersecurity and GDPR for SaMD
  5. The CE Marking Process for SaMD
  6. Clinical Evidence for SaMD in the EU
  7. Post-Market Surveillance for SaMD
  8. SaMD Market Access & Reimbursement in Europe
  9. Investment Trends in European Digital Health
  10. Why SaMD Launches Fail in Europe

Each article contains actionable insights, is based on updated 2025 regulations, and provides best practices to help you succeed in the European MedTech landscape.