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The European Union Medical Device Regulation (EU MDR) represents a significant overhaul of the regulatory framework for medical devices. At Artixio, we recognize the importance of equipping industry stakeholders with the knowledge and tools necessary to thrive in this evolving regulatory landscape. As a trusted partner in regulatory compliance solutions, we are proud to present this comprehensive eBook on the Regulation of Medical Devices under EU MDR in the European Union. This eBook provides a detailed exploration of the EU MDR, its implications, and practical guidance for manufacturers, notified bodies, and other stakeholders. 1. Introduction 2. Medical Device Classification under EU MDR 3. Economic Operators under EU MDR 4. Person Responsible for Regulatory Compliance (PRRC) 5. European Authorized Representative (EAR) 6. Conformity Assessment of Medical Devices under EU MDR 7. Understanding the CE Marking Process for Medical Devices under EU MDR 8. Class I Medical Devices and CE Marking 9. Role of Notified Bodies in CE Certification of Medical Device 10. Essential Considerations for Reprocessing Single-Use Devices in Accordance with EU MDR 11. Regulation of Reusable Medical Devices under EU MDR 12. Understanding System and Procedure Packs in Accordance with EU MDR 13. Combination Products under EU MDR: Understanding Article 117 14. Navigating Regulatory Gray Areas: Borderline Devices in the EU MDR and IVDR Era 15. Medical Devices Labeling Requirements under EU MDR 16. Navigating the UDI System under EU MDR and EU IVDR 17. EUDAMED Modules 18. Post-CE Compliance under EU MDR (Amazon)