Svetlana A completed this course and earned a Pharmuni certificate.
EU Medical Device Regulation
ISO 9001
Quality Management System
Certificate Registration No.: 12 100 60610 TMS
About the EU Medical Device Regulation
EU Medical Device Regulation introduces the essential structure, requirements, and practical implications of Regulation (EU) 2017/745 for professionals working with medical devices in Europe. This course explains how the MDR shapes classification, conformity assessment, economic actor responsibilities, clinical and technical evidence, and post-market obligations required for placing and maintaining medical devices on the EU market.
You will gain a practical understanding of how the MDR differs from the former Directives and how it affects market access, technical documentation, device classification, conformity routes, and lifecycle compliance. The course explores the structure of the regulation, Annex VIII risk classification, the main conformity assessment pathways, General Safety and Performance Requirements, the roles of economic actors and the PRRC, and core post-market surveillance and vigilance duties.
The course focuses on key aspects of the MDR in practice, including:
• The purpose, structure, and impact of Regulation (EU) 2017/745
• Device classification and conformity assessment routes under the MDR
• Economic actors, PRRC responsibilities, and technical compliance expectations
• Post-market surveillance, vigilance, and ongoing lifecycle obligations
Through structured explanations and practical examples, this course helps learners understand how MDR requirements influence product development, market access, and post-market control in the EU. It is best suited to professionals working in regulatory affairs, quality assurance, product development, clinical evaluation, or market access in the medical device sector.
This course is ideal for professionals working in regulatory affairs, quality assurance, product development, clinical evaluation, or marketing within the medical device sector. No matter your background, you’ll gain practical insights and tools to help navigate the MDR with confidence. By the end of this course you will be able to:
Learning Objective 1
Explain how the EU Medical Device Regulation (MDR) affects the marketing and market access of medical devices in the EU.
Learning Objective 2
Describe the main requirements and scope of the MDR, including the available conformity assessment routes.
Learning Objective 3
Explain how medical devices are classified by risk according to the rules in Annex VIII of the MDR.
Learning Objective 4
Identify the roles and responsibilities of economic actors under the MDR.
Learning Objective 5
Explain the General Safety and Performance Requirements (GSPRs) and their role in the conformity assessment process.
Learning Objective 6
Describe the role of the Person Responsible for Regulatory Compliance (PRRC) within different types of economic actors.
Learning Objective 7
Outline the vigilance and post-market surveillance (PMS) procedures under the MDR, including serious incident reporting and field safety corrective actions (FSCAs).