A ユニークなデバイス識別 system has been introduced under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), which become applicable from 26 May 2021 and 26 May 2022 respectively.
The UDI system enhances the identification of medical devices and makes it easier to trace them when necessary. It also increases the effectiveness of post-market safety-related activities for devices, improves incident reporting, enhances targeting of field safety corrective actions, reduces medical errors and helps the fight against counterfeit devices.
Igavia is providing support in implementing the obligations and requirements introduced by the new UDI system. You can access here.
The service provides support on UDI assignment, labelling and registration of devices. It also provides support on the use of the European Medical Devices Nomenclature (EMDN), which the European Commission has made available to manufacturers and other natural or legal persons required by the MDR and IVDR to use it.
And the FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.
With best regards,
Igavia Science Medical Devices Team