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:
- What Is Software as a Medical Device (SaMD)?
- Rule 11 Explained: Classifying SaMD in the EU
- Building a Compliant QMS for SaMD
- Cybersecurity and GDPR for SaMD
- The CE Marking Process for SaMD
- Clinical Evidence for SaMD in the EU
- Post-Market Surveillance for SaMD
- SaMD Market Access & Reimbursement in Europe
- Investment Trends in European Digital Health
- 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.