Achieving Market Readiness for Digital Medical Devices in Europe
Digital Health
Navigating Europe’s fragmented regulatory and reimbursement landscape is one of the greatest challenges for innovators in digital medical devices. This programme provides a comprehensive introduction to the key frameworks, certification processes, and market access pathways for Digital Medical Devices (DMDs) under the European Health Data Space (EHDS).
Participants will gain practical knowledge of regulations such as DiGA and PECAN, learn how to plan certification and post-market surveillance, and explore strategies to build compliance, quality, and trust across European healthcare markets.
Applications to this programme are ongoing. Don’t miss this opportunity and enrol now!
What you get
REGULATORY INSIGHTS
Master the core frameworks for Digital Medical Device approval and compliance
MARKET ACCESS
Understand how certification, reimbursement, and quality standards shape success
ETHICAL PRACTICE
Learn the principles of transparency and responsible communication
FLEXIBILITY
Study at your own pace with an online format designed to fit your schedule
HANDS-ON
Apply health data management concepts through interactive exercises and real-world case studies
CERTIFICATION
Receive certification validating your health data management skills and knowledge
EXPERT GUIDANCE
Learn directly from leading experts behind Europe’s most renowned institutions in health data management
What you'll learn
Learning Outcomes
- ✅ Identify and interpret the regulatory frameworks, evidence requirements, and reimbursement pathways for digital medical devices
- ✅ Apply quality and certification standards to ensure compliance, patient safety, and data security throughout the product lifecycle
- ✅ Develop strategies for transparent, ethical communication and market access across European contexts
- ✅ Navigate EU frameworks such as DiGA and PECAN for DMD approval
- ✅ Plan certification and evidence-generation strategies
- ✅ Understand post-market surveillance and compliance processes
- ✅ Apply quality and safety standards across the DMD lifecycle
- ✅ Develop ethical and transparent marketing communication strategies
Curriculum
Eligibility Requirements
Open to students, researchers, professionals in the healthcare industry, and entrepreneurs developing or managing digital medical devices, as well as policymakers and regulators involved in European health technology certification and market access.
Partners
Option care health
ORCHA Healthcare
Petra Hoogendoorn
University of Luxembourg
