LEARN HOW TO APPLY THE MDR TO YOUR OWN MEDICAL DEVICE
The Medical Device Regulation (MDR) is often seen by developers of medical technology as complex and time-consuming. But those who truly understand the rules can actually turn them into an advantage. During this two-day MDR Course at the University of Twente, you will not only learn to understand the MDR but also to apply it directly to your own product — together with experts from the field. This way, regulation becomes a valuable opportunity to bring your innovation to market faster and more safely.
WHAT TO EXPECT
The MDR Course combines theory, practice, and personal guidance. Before the training, you will have an intake interview to assess your specific MDR needs. Based on this, you’ll be matched with the right (medical) expert or end-user. You will then spend two intensive days working on concrete assignments and cases drawn from your own professional context.
Topics covered include:
- Determining intended use, classification, and CE route
- Applying relevant ISO standards (13485, 14971)
- Performing a risk analysis with a multidisciplinary team
- Preparing tests to demonstrate clinical benefit
- Developing a preclinical evaluation plan and clinical investigation design
FOR WHOM?
The MDR Course is designed for (start-up) entrepreneurs, researchers, or product teams involved in developing medical devices. Whether you are at the start of the certification process or have already taken concrete MDR steps, this training helps you navigate regulation, quality assurance, and risk assessment with confidence.
PRACTICAL INFORMATION
Dates: Spring 2026 (subject to sufficient registrations)
Location: University of Twente, Enschede
Price: €3,000 per company (max. 3 participants per organisation)
This course can be funded with a Santiago WISE Award – more information
READY TO PUT MDR INTO PRACTICE?
Turn regulation into a powerful tool for innovation. Register today for the MDR Course and discover how to make your medical device both compliant and market-ready.
TechMed Academy / Technohal (Building 18)
Hallenweg 5, 7522 NH Enschede, The Netherlands
E-mail: techmedacademy@utwente.nl
Phone: +31 (0)53 489 8401
Read our cancellation policy here: UT Course Cancellation Policy