Traceability
Traceability refers to the ability to trace the history, application, or location of a medical device throughout the supply chain. Under the EU MDR, this is ensured through the UDI system, the EUDAMED database, and post-market surveillance requirements. In a broader sense, traceability also encompasses the complete documentation of all process steps within the quality management system, including the creation and maintenance of accompanying documents.
In the IFU translation process, traceability means that it must be possible at all times to determine which source text version underlies a language version and which changes were made in which revision.
Frequently Asked Questions
How is traceability ensured in the IFU translation process?+
Traceability in the translation process is ensured through versioned source documents, documented translation and review steps, change logs, and the mapping of each language version to the source document revision. An auditable record must show which version of the source text was translated, reviewed, and released by whom and when.