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Global traceability of medical devices has been a vision for decades and has taken 10 years of work by regulators, the medical device industry, the healthcare community, and other stakeholders to turn this vision into a rule. The vision started to become a reality, with the 24 September 2013 FDA (US Food and Drug Administration) final rule on the UDI system. The intention of Medical Device UDI requirements is to provide standard device identification and its associated information to support various public health initiatives, most notably to support post-market surveillance (PMS) activities. These include adverse event reporting, inclusion of information related to specific devices in device databases, disease-specific registries, and large population-based data sets, such as claims data. To permanently ensure the complete identification and traceability of instruments, the American and European UDI Directives require a direct marking of UDI code (Unique Device Identifier) on to the device itself and termed as “Direct part marking (DPM)”.
Reusable medical products that require multiple processing cycles – such as surgical instruments – must bear a direct mark. Directly applied UDI marks (Direct Part Marking) on the medical device should meet many criteria to ensure that the device integrity and its ability to achieve intended purpose are maintained even after Direct Part Marking. This White Paper will give insights about Unique Device Identification System and its components, Direct Part Marking, Methods of Marking, Technical considerations, Problems Encountered/Challenges, Quality assessment through verification, Symbol Grading of marking on Medical Device and more importantly the execution approach for Medical Device Direct Part Marking. Download whitepaper to continue reading.