UDI system and RFID technology

The Food and Drug Administration (FDA) and the European Commission (EC) have made the traceability of medical devices (MD) a strategic priority developing internationally harmonized legislation for the univocal identification of such equipment, named with the acronym UDI (Unique Device Identifier). The FDA issued the standard on 24 September 2013. The full application is set on 24 September 2021, for class I and unclassified medical devices (later you can find the classification of MD), while for devices that require a permanent marking the date will be on 24 September 2022. As regards the EU, two new regulations were issued in 2017: Regulation (EU) 2017/745 on medical devices; Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The full application of the two Community Regulations is set on 26 May 2021 for medical devices, while for medical-diagnostic devices in vitro will be on 26 May 2022. Classification of medical devices All … Continue reading UDI system and RFID technology