Introduction: Why UDI/Device Registration Is More Than Just Compliance
Under the EU MDR and IVDR, traceability isn’t optional-it’s foundational. EUDAMED’s Module 2 (UDI/Device Registration) plays a pivotal role by linking device identifiers with regulatory documentation, enabling full lifecycle visibility. This isn’t just about meeting requirements-it’s about building trust, ensuring patient safety, and unlocking operational clarity across the EU market.
Read more in our latest Point Of View EUDAMED UDI:Device Registration
