Module 16 2022

05/09/2022

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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• UDI is an enabler giving: • Supply Chain transparency • Traceability of Medical Devices within the Supply Chain • Increased security • Detection of counterfeits • Protection of brands • Automated order to cash processes • Mobile technology through apps • Empowering the consumer / patient • Authentication of products • Compliance Traceability

The Organisation for Professionals in Regulatory Affairs

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