Practical Regulatory Affairs: EU Medical Device Regulations

About Practical Regulatory Affairs: EU Medical Device Regulations

The EU Medical Device Regulations (MDR 2017/745) represents the biggest change to medical device legislation in Europe for over 20 years. The MDR affects all medical device manufacturers (and others!) wanting to sell devices in the EU. This course focuses on the practical application of the MDR, using real-world examples and exercises to help you understand not only what the Regulations mean, but what we need to do to comply with them. First written in 2020, this course quickly became the best-selling regulatory affairs course on Udemy with over 1,700 students enrolled. Now updated in 2025 with all the latest information, templates and resources to help you navigate EU medical device regulations. This is the perfect entry point for anyone looking to understand how medical devices are regulated in the EU, with several opportunites available for guided learning and deep dives into more detailed topics of interest, specific to your device or needs. We also discuss how to leverage EU market approvals in other global markets of interest. Written and developed by a group of Regulatory Affairs professionals currently working in industry, this course focuses on the most common issues and questions we receive from medical device manufacturers looking to enter the market under MDR.