ISO 13485: 
Section 7.5.9 Traceability

Traceability is the capacity to identify and trace the history, distribution, location and application of products, parts and materials. ISO 13485 requires organizations to document procedures for traceability. These procedures will define the extent of traceability in agreement with applicable regulatory requirements and the records that need to be maintained.  

In addition to general traceability requirements, ISO 13485 has specific requirements for implantable medical devices. The records required for traceability for implants must include records of components, materials and conditions for the work environment that is used, if these have the potential to cause the medical device to not satisfy its specified safety and performance requirements.

In regards to suppliers and distributors, they must maintain records of the distribution of medical devices to allow traceability. These records must be available for inspection. In addition, records of the name and address of the shipping package consignee must be maintained.

Integration of traceability in risk management

If your risk analysis specifies that there are critical characteristics that must be identified, identification, traceability and management of status will allow you to control these characteristics. The level and extent of identification and traceability will be determined in accordance to the type and class of the medical device.


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