This ready-to-use verification form provides medical device manufacturers with a structured, documented checklist to confirm that UDI labels and UDI carriers meet all requirements of EU MDR (2017/745) and IVDR (2017/746) before a device is placed on the market.
The UDI carrier is the medium on which the UDI is applied or stored in both machine-readable form (AIDC — Automatic Identification and Data Capture) and human-readable form (HRI — Human Readable Interpretation), and must be placed on the label or the device itself, as well as on all higher levels of device packaging.
This form helps your team systematically verify that every label and carrier is complete, correct, and compliant.
This ready-to-use verification form provides medical device manufacturers with a structured, documented checklist to confirm that UDI labels and UDI carriers meet all requirements of EU MDR (2017/745) and IVDR (2017/746) before a device is placed on the market.
The UDI carrier is the medium on which the UDI is applied or stored in both machine-readable form (AIDC — Automatic Identification and Data Capture) and human-readable form (HRI — Human Readable Interpretation), and must be placed on the label or the device itself, as well as on all higher levels of device packaging.
This form helps your team systematically verify that every label and carrier is complete, correct, and compliant.
