Module 16 2024

17/10/2024

Traceability

• What is driving the need for traceability?

• Consistent level of medical errors

• Increased recalls

• Counterfeit products – Brand Protection

• Increasing Supply Chain costs

The Organisation for Professionals in Regulatory Affairs

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Traceability

• The EU Medical Devices Regulation 2017/745 and In-Vitro Diagnostic Medical Devices Regulation 2017/746 is just one area where traceability regulations are emerging globally. • They contain a series of extremely important improvements to modernise the previous system. Including: • ‘Improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification’

The Organisation for Professionals in Regulatory Affairs

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