Update your medical device UDI data and labels: This year FDA Class I / Next year EU MDR
When you’re involved with the regulatory requirements in the medical device industry, deadlines are usually on the horizon. Join speakers from Reed Tech Life Sciences and NiceLabel® for a review of what you need to know and take action on to address the following:
US FDA September 24, 2022 — Class I devices and unclassified devices are required to be labeled with UDI and have UDI data reported to GUDID. Have you verified all products in your portfolio are currently compliant? Can you claim any of the Class I UDI exceptions?
EU MDR May 26, 2021 — Due to impacts of the COVID-19 pandemic, the Date of Application (DoA) for the EU Medical Device Regulation (MDR) has been postponed for one year until May 2021. This MDR postponement along with the delay of the EUDAMED launch until May 2022 have triggered many industry questions regarding the implementation timing of MDR requirements and the interim use of legacy Medical Device Directive procedures. Do you have uncertainty on EU medical device registration and labeling requirements or timing?