This short course introduces the fundamental principles of medical device regulation in the European Union (EU), with a focus on OTC medical devices. It is ideal for individuals working in a regulatory or brand management role for OTC medical devices who are new to the EU industry or your organisation, or would like a refresher on the foundations of medical device regulation.

This course is divided into 7 modules:

• Module 1 – provides an overview of how medical devices are regulated in the EU.
• Module 2 – explores the definition of a medical device and how medical devices are classified in the EU.
• Module 3 – introduces the key stakeholders and economic operators in the supply chain of medical devices, including their responsibilities.
• Module 4 – provides an overview of the conformity assessment process and CE marking of devices.
• Module 5 – focuses on market surveillance and traceability of devices, and why this is so important.
• Module 6 – gives an overview of the labelling requirements for devices and the accompanying information for use.
• Module 7 – gives a brief overview of the advertising of medical devices and how it is regulated in the EU.

Some modules include a short quiz to check your understanding of the content covered. These are for your own learning and do not contribute to your final certification.

At the end of the course, there is a final test. Once completed successfully, you will receive a certificate of participation for your training records.

It should take approximately 2 hours to complete the course and final test.