Identification and traceability of medical devices: role and responsibilities of economic operators and application tools for the Regulation (EU) 2017/745

ABSTRACT

A poor management system for medical devices may pose a major threat to the health of patients or end users. A medical equipment must always be recognizable and traceable in the supply chain as well as on the market, for any purpose at all. When it comes to things that are fake or could be hazardous, this need is crucial. The European Regulatory Framework for Medical Devices has been modified by the new Regulation (EU) 2017/745 of the European Parliament and Council. The key novelty is the implementation of a UDI system for the devices' individual identification within the European Union. The Regulation highlights the significance of each economic operator's participation across the management and supply chain of medical devices. Manufacturers, authorized representatives, importers, and distributors must now take on particular tasks and assure compliance with the new rules. This technical report, which is primarily aimed at business professionals, analyses the new requirements for medical device traceability introduced by Regulation (EU) 2017/745, offers resources for proper medical device management, and considers how the ongoing COVID-19 emergency will affect the application of the new regulations.