Webinar Regulatory Update on UDI: What you need to know about UDI marking of medical devices, instruments and implants
April 22nd, 2020 / 5:00 - 6:00 PM Central European Time
10:00 AM (CDT)
Christian Söhner, Global Vertical Manager Medical (FOBA Laser Marking + Engraving)
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. Although already in place for the US, the implementation of the MDR for the European market is often still unclear. Due to the Corona pandemic, the official start date for the EU has now been changed from 26 May 2020 to 2021.
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