Importance of Identification and Traceability

The ISO 13485 standard places great emphasis on identification and traceability throughout the product realization process so that “product safety” can be fully achieved. There are detailed requirements for identification, traceability and status identification throughout the standard whereas, the clauses 7.5.8 and 7.5.9 of ISO 13485:2016 include the key requirements. Implementation of these requirements according to the quality management system and product profile is the key to a successful ISO 13485 system. In addition to keep the product realization processes under control, the terms “Identification and Traceability” are of great importance in order to fully implement requirements such as recall, vigilance and advisory notice issue, which are contained within the standard and worldwide legal regulations. If these conditions are not fulfilled, it will not be possible to comply with the regulations in case of any feedback from the market or customer complaint. This can lead to the loss of the organizational reputation and/or regulatory sanctions.

In addition to medical devices intended for general use, ISO 13485: 2016 requires additional requirements for the identification and traceability of implantable and active implantable devices. Similarly, the new MDR, EU 2017/745 defines additional requirements for implantable devices such as an “implant card”. It is vital for the manufactures of such devices to fulfil these requirements completely in terms of product safety. It is also necessary to take into account the record keeping requirements of the new MDR (EU 2017/745) and IVDR (EU 2017/746) for CE marked medical devices.

The first question that comes to mind during implementation is to the depth of “Identification and Traceability” within the product realization processes. As long as there are no additional regulatory requirements, the best answer to this question would be “until product safety is under control”.

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