Program Overview

MDR: Omdenken van last naar nuttig toepassen

Introduction to the Medical Device Regulation (MDR) Course

The Medical Device Regulation (MDR) is often viewed by medical technology developers as complex and time-consuming. However, understanding the regulations can provide a competitive advantage. This two-day MDR Course at the University of Twente teaches participants not only about the MDR but also how to apply it to their own products, alongside field experts. This approach transforms regulatory compliance from a burden into an opportunity to bring innovations to the market more quickly and safely.

What to Expect

The MDR Course combines theory, practice, and personal guidance. Before the training, an intake interview determines the participant's specific MDR needs, after which they are matched with the appropriate medical expert or end-user. Over two intensive days, participants work on concrete assignments and cases from their own practice.

Topics Covered

• Determining intended use, classification, and CE-route
• Applying relevant ISO standards (13485, 14971)
• Conducting a risk analysis with a multidisciplinary team
• Preparing tests to demonstrate clinical benefits
• Developing a preclinical evaluation plan and clinical research design

Unique Aspects of the Course

• Participants work with their own product or innovation
• Receive direct feedback from University of Twente experts and medical specialists
• Engage in hands-on assignments and use concrete templates for further application
• The course is applicable for both start-ups and research departments
• Includes personal intake and individual guidance

Target Audience

The MDR Course is designed for (start-up) entrepreneurs, researchers, or product teams involved in the development of medical devices. Whether at the beginning of the certification process or having already taken concrete MDR steps, this training helps navigate the process of 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 (maximum of 3 participants per organization)

By transforming regulatory compliance into a powerful tool for innovation, the MDR Course offers a unique opportunity for medical device developers to ensure their products are both compliant and market-ready.