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
FAQs
How do I enroll in the EU Medical Device Regulation online course?
Create a free Pharmuni account from our registration page, open this course page and click “Start Learning” button on top of the page. You can start learning instantly from any device.
How do I complete the quiz and download my certificate?
Work through all lessons, then pass the short quiz with ≥ 80 %. When you pass, the Receive Certificate button appears on top of this page—click it to download your PDF certificate, and you’ll also find it later under My Certificates in your dashboard.
Is the EU Medical Device Regulation certificate recognized, and how long is it valid?
Pharmuni certificates are backed by ISO 9001 of our mother company, Zamann Pharma Support, and are accepted by employers worldwide. Each certificate stays valid for two years from its issue date. You can learn more about our certificates here.
What career benefits will I gain from EU Medical Device Regulation?
To create this course, we constantly monitor the job market. The course teaches job-ready skills, boosting your credibility for pharmaceutical roles, especially in Quality Management. Add the credential to LinkedIn or your CV to stand out in recruiter searches.
How long does EU Medical Device Regulation take, and can I learn at my own pace?
All Pharmuni content is fully self-paced—study whenever it suits you. Most learners finish a module within one week, but there is no deadline as long as your subscription is active.
What if I don’t pass the quiz the first time?
No worries—you can retake the quiz (and the course) as many times as you need until you achieve the passing score and download your certificate.
How do I upgrade to Pharmuni Premium, and what extra perks do I get?
Log in, visit the Plans page and choose a Monthly or Annual plan in your local currency. Premium unlocks 45+ courses, ISO-9001 backed certificates, unlimited Skill-Tree access, a pharma CV & cover-letter builder, and a free 30-minute VIP career-coaching session every month.