Basic BUDI-DI

Assisting manufacterers in understanding the Basic UDI-DI (BUDI-DI) assignment, its regulatory context, and key implementation challenges.

Addressing Basic UDI-DI assignment under the MDR and IVDR

This paper is focused on the Basic UDI-DI, its regulatory requirements, and key considerations for implementation.

This document covers the legislative aspects associated with clinical evaluation under MDR from a Notified Body perspective.

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The European Database on Medical Devices (EUDAMED) is the IT system developed by the European Commission as part of MDR and IVDR implementation.

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Clinical evaluation is an ongoing process that starts during device development and continues throughout its lifecycle.

It ensures your device’s safety and performance are supported by sufficient clinical evidence for certification and beyond.