Webinar Regulatory Update on UDI: What you need to know about UDI marking of medical devices, instruments and implants
December 6, 2022 / 15-16 (CET) / 8-9 AM (CST)
Christian Söhner (FOBA) and
Rian Froemming (FOBA)
What you can expect:
With the UDI system (Unique Device Identification) manufacturers are obliged to identify and register medical devices. In the EU, the UDI is regulated within the framework of the MDR (Medical Device Regulation). In the USA, the FDA is authoritative. Seamless product tracking, less product piracy and highest patient safety are the goals. The challenges for manufacturers and marketers are no less demanding.
We bring you up to date on the current status of UDI direct marking of medical devices and give an overview of the UDI system according to MDR and FDA.
- why the UDI code is much more than a label and should not be underestimated
- what has to be considered for the technical implementation
- things to know about readability and code size
- how to achieve process reliability during direct marking
Following the discussion, the speakers will provide practical answers to the participants' questions.