Gary Saner of Reed Tech and Mark Cusworth of PRISYM ID discuss the new EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), and the impact on labeling, including label formats, IFU information and symbols.
WATCH NOW FOR:
- Label requirements comparison EU MDR vs MDD and AIMDD
- Comparison of EU MDR & FDA UDI
- Information on the label – what has to be changed?
- Label – before and after EU MDR/IVDR
- ROI – Label Mass Change
- Barcode considerations
- Alignment of your label content with your EUDAMED data record submission
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