Webinar UDI requirements - Are you ready now?
24. Februar 2022 / 4:00 - 5:00 PM Central European Time
10:00 AM Eastern Time | 09:00 AM Central Time
Jeffrey Kniptash, Global Strategic Account Manager (FOBA Laser Marking + Engraving)
Christian Söhner, Global Vertical Manager Medical (FOBA Laser Marking + Engraving)
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. 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 and the bottle neck of notified bodies not being certified for the MDR, the official start date for the EU had been changed from 2020 to 2021. The deadline for class I products is now due on September 24th, 2022 complying to the FDA.
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