EU MDR Archives

European Database on Medical Devices (EUDAMED): Objectives

by Sudhriti M | Nov 7, 2025 | Medical Device

European database on medical devices (EUDAMED) is the European Commission’s centralized IT system for medical device and IVD regulation. It has been designed to enhance transparency, traceability, and coordination across EU Member States. EUDAMED serves as the digital...

Introduction to EU Medical Device Regulation (MDR): Key Terms

by Sudhriti M | Nov 5, 2025 | Medical Device

European Union Medical Device Regulation (EU MDR) 2017/745 is a framework governing safety and performance of medical devices in EU. It came into full effect on May 26, 2021, replacing the previous Medical Device Directive (MDD). It aims to address gaps in oversight...

A Guide to CE Mark For Medical Devices: What, How, & Why

by Sudhriti M | Sep 15, 2025 | Medical Device

To secure CE mark, the manufacturer is expected to ensure all EU-wide requirements for the medical device have been complied. If the device complies with strict safety, health, and environmental protection benchmarks, it may be granted the CE mark certification....

European Database on Medical Devices (EUDAMED): Objectives

Introduction to EU Medical Device Regulation (MDR): Key Terms

A Guide to CE Mark For Medical Devices: What, How, & Why

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