Master UDI-DI: The New Layer Many MedTech Companies Don’t Understand

Medical Device made Easy Podcast · Apr 30, 2026

The implementation of Unique Device Identification (UDI) has already transformed regulatory compliance in the medical device industry.

Now, Europe is introducing an additional layer: Master UDI-DI — adding both structure and complexity to the system.

Understanding the UDI Structure

To fully understand Master UDI-DI, it’s important to distinguish between the different levels:

• UDI-DI → Identifies a specific device

• Basic UDI-DI → Groups devices with the same intended purpose and characteristics

• Master UDI-DI → Applies to highly individualized devices with specific design parameters

This…