Navigating EU Medical Device Regulations

Compliance made clear: From design to reimbursement

Medical device development is complex—and in the European market, regulatory compliance and reimbursement requirements can make or break a product’s success. Too often, these critical considerations are addressed late in the process, leading to costly delays, redesigns, and missed opportunities. This course exists to change that.

Navigating EU Medical Device Regulations is a fully online, asynchronous program designed to give professionals a clear, practical understanding of the European regulatory and reimbursement landscape. In just 1 ECTS, you’ll learn how MDR and IVDR frameworks shape product development from design and classification to approval, clinical evaluation, and post-market surveillance. You’ll also gain foundational insights into health technology assessment and reimbursement systems within the EU healthcare environment.

The value of this course lies in its ability to help you integrate compliance and market-access strategies early—saving time, reducing risk, and accelerating your path to market. Unlike generic regulatory overviews, this program offers a Eurocentric perspective, practical examples, and comparisons to U.S. FDA pathways, making it ideal for innovators, regulatory specialists, and R&D teams working on global strategies.

With flexible, self-paced learning and expert-curated content, this course empowers you to navigate complex regulations confidently and turn compliance into a competitive advantage.

Start

Any time: License for 90 days starting from the order date

Registration information

Yulia Tikkanen, Project Manager

+358 10 837 3871

yulia.tikkanen@aaltoee.fi

Learning Outcomes

After completing the course, you will be able to:

Understand the EU regulatory framework for medical devices.
Navigate the classification and approval pathways associated with the medical device regulation.
Outline essential technical documentation and applicable standards to demonstrate compliance with the medical device regulation.

For

This course is designed for professionals who work with medical devices or in vitro diagnostics and need a clear, practical understanding of how EU regulations affect product development. It is especially useful for those who must interpret MDR and IVDR requirements, determine correct device classification, and ensure that documentation and evidence meet regulatory expectations.

This course is suitable for

regulatory affairs specialists
quality professionals
R&D engineers
software/SaMD developers
product and project managers
entrepreneurs preparing for EU market entry in medtech and healthtech companies.

Content and Schedule

The course provides a comprehensive introduction to the EU regulatory and reimbursement landscape for medical devices and health technologies. Key topics include:

MDR (EU 2017/745) and IVDR (EU 2017/746): device classification, approval pathways, and comparison to U.S. FDA regulations
Technical documentation and ISO standards (ISO 13485, ISO 14971, ISO 62304)
Clinical evaluation and post-market surveillance requirements
Health Technology Assessment (HTA), valuation, and reimbursement systems in the EU

The course takes approximately 27 hours to complete and is equivalent to 1 ECTS. It includes modular content with a mix of video lectures, readings, and practical assignments.

You can complete the course at your own pace, either by spreading the content over several weeks or by following a more focused schedule.

Learners have 3 months of access to the course materials, allowing flexibility to study at their own pace. To complete the course, participants must engage with all modules and pass the final assignment that evaluates their understanding of EU regulatory frameworks, technical documentation, and reimbursement strategies.

Instructors

Craig Carlson

Craig Carlson is a University Lecturer at Aalto University’s Department of Electrical Engineering and Automation, where he began his role in early 2024. His position is unique, combining academic expertise with a strong focus on lifewide learning development, supported by Aalto’s seed funding initiative to create innovative learning opportunities for professionals.

Originally from Johannesburg, South Africa, Carlson holds a Master’s and PhD in Electrical Engineering, complemented by industry experience prior to his doctoral studies. His research journey took an unconventional turn when he explored the intersection of ultrasound technology and tattoo inks, investigating how tattoos affect medical ultrasound imaging and vice versa. This reflects his broader interest in expanding the applications of ultrasound beyond traditional diagnostics.

Currently, Carlson's work centers on identifying and shaping learning content that bridges academic knowledge with industry needs, ensuring that upskilling opportunities are relevant for professionals outside traditional degree programs. He collaborates closely with faculty and industry partners to design courses that meet evolving workplace demands.

Carlson brings a practical, interdisciplinary perspective to teaching, blending technical expertise in medical technologies with a passion for lifelong learning and innovation.

Program Fee and Registration

The fee for the Navigating EU Medical Device Regulations online course is € 150 (+ VAT).

This program has adopted Aalto EE's new Customer ID, and it is delivered on Aalto Learning Experience Alex e-learning environment. Before ordering, please visit aaltoee.fi/customerid.