EU Medical Device Regulation
EU Medical Device Regulation
Version 1.0
Released on 01/07/2025
Master EU Medical Device Regulation (MDR) fundamentals: classification, conformity routes, GSPRs, economic actors and post-market duties. This is a concise, case-driven online course with certification.
- English
- Available on app
- + Certificate
Version 1.0
Released on 01/07/2025
EU Medical Device Regulation
Released on 01/07/2025
- intermediate
- + Certificate
- Available on app
- Online at your own pace
- Shareable certificate of completion
About the EU Medical Device Regulation
Gain a practical, end-to-end understanding of Regulation (EU) 2017/745 in this intermediate-level MDR course. Through concise lessons, case studies, videos and quizzes you’ll learn how the Regulation replaces the old Directives, how to navigate its chapters and annexes, classify devices with Annex VIII, choose the right conformity-assessment route, meet General Safety and Performance Requirements, and understand the legal duties of manufacturers, authorized representatives, importers, distributors and the PRRC. The course also explains Unique Device Identification, EUDAMED registration, clinical-evidence expectations, and the essentials of post-market surveillance, PSURs and serious-incident reporting. Complete the final assessment to earn a certificate and apply MDR principles confidently in product development, regulatory submissions and market oversight.
ISO 9001
Quality Management System
Certificate Registration No.: 12 100 60610 TMSPharmuni Certificate
Zamann Pharma Support GmbH
Personnel qualification in the field of pharmacy, medical technology and quality assurance.
Consulting service in the field of pharmacy, medical technology and quality assurance.
Your Learning Objectives
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).
Benefits of this Course
Get valuable resources, and ISO backed certification through our assessment of your knowledge and access global jobs only for Pharmuni alumni.
- Downloadable Resources
- Fast-Tracked Qualification
- Exclusive Assessment Quiz
- Skill Tree Levelup
- Customer Support
- Sharable & Downloadable Certification