CE Marking & MDR Compliance Training – Learn EU Medical Device Regulations with Confidence
What is CE Mark / MDR Training?
CE Marking / MDR Training is a specialized training course that helps manufacturers, quality managers, and regulatory professionals understand how to comply with European Union (EU) regulations for medical devices. This training focuses on Medical Device Regulation (EU MDR 2017/745) and how to achieve CE certification to legally sell medical products in the European market.
It covers everything from product classification and technical documentation to conformity assessment, notified bodies, and post-market surveillance.
Why CE Marking & MDR Training is Important
🇪🇺 Mandatory for exporting medical devices to the European Union
📄 Understand complex EU MDR 2017/745 regulatory requirements
🏥 Ensure product safety, clinical evidence, and labeling compliance
🛡️ Reduce regulatory risks and avoid costly rejections
✅ Build internal capacity to handle technical files and audits
📈 Strengthen your brand’s credibility in global medical markets
What You Will Learn
Our CE Mark / MDR Training is designed to provide a full understanding of the certification process and the regulatory obligations under MDR:
| Module | Topics Covered |
|---|---|
| 1. Introduction to CE Marking | What is CE marking, who needs it, and how to get started |
| 2. Overview of MDR (EU 2017/745) | Key requirements and differences from MDD (old directive) |
| 3. Device Classification & Risk Levels | Class I, IIa, IIb, III devices explained |
| 4. Technical Documentation & Clinical Evaluation | Requirements for technical files, clinical data, and performance |
| 5. Role of Notified Bodies | Conformity assessment procedures and how to work with them |
| 6. Post-Market Surveillance & Vigilance | Ongoing responsibilities after CE certification |
| 7. Labeling, UDI & EUDAMED Compliance | MDR labeling, Unique Device Identifier (UDI), and database use |
Who Should Attend?
Medical Device Manufacturers
Quality Assurance (QA) Teams
Regulatory Affairs Professionals
Export & Compliance Officers
Product Development Teams
ISO 13485 Implementation Staff
Consultants & Certification Managers
Training Formats Offered
💻 Online (Live Zoom or Self-Paced eLearning)
🏢 On-Site Corporate Training Workshops
📍 Specialized Industry Sessions (SMEs, Startups, OEMs)
📜 Certificate of Completion Provided
Get CE Certified. Enter the EU Market with Confidence.
Our CE Marking and MDR Compliance Training gives you the knowledge and tools to successfully bring your medical devices to market in Europe. Whether you’re a manufacturer, OEM, or exporter, this training helps you navigate the complex EU regulatory landscape with clarity.
📞 Contact us today to enroll in CE Mark/MDR Training or request a tailored session for your business.