Gestión de la calidad (QMS) 12 elementos
ISO 13485 / Unique Device Identification (UDI) Checklist
Esta lista de verificación está en inglés.
A checklist for assigning, applying, and maintaining Unique Device Identification (UDI) for medical devices, aligned with ISO 13485 identification and traceability clauses and FDA/EU UDI requirements.
ISO 13485:201621 CFR 830EU MDR 2017/745
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UDI Assignment
- Is a UDI assigned to each device and applicable packaging level using an accredited issuing agency? *
- Does the UDI include a device identifier (DI) and, where applicable, a production identifier (PI)? *
- Is a system in place to identify product status throughout realization? *
Marking & Label Application
- Is the UDI carrier presented in both human-readable and AIDC (e.g., barcode) formats on the label? *
- For reusable devices requiring reprocessing, is UDI applied as direct part marking? *
- Is UDI label placement and legibility verified as part of labeling control? *
Database Submission
- Are UDI data elements submitted to the applicable database (FDA GUDID and/or EUDAMED)? *
- Are submitted UDI records verified for accuracy and completeness? *
- Are UDI database records updated within the required timeframe when data elements change? *
Traceability & Change Control
- Does traceability enable linking the UDI-DI to production records and distribution (implantable/high-risk devices)? *
- Is a new device identifier (DI) issued when a change triggers a new UDI-DI per the applicable rules? *
- Are UDI records retained and updated when device attributes change? *
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