Life Sciences Blog

Webinar Recording: Update Your Medical Device UDI Data & Labels-This Year FDA Class I | Next Year EU MDR

by | Jun 18, 2020

3:55 Webinar Recording Excerpt

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? (Note: See the latest update on FDA compliance enforcement for Class I).

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?


See the full presentation here with a short registration. Thank you!

Questions? We are here to help. Visit our Knowledge Center or Contact Us. 

Reed Tech Life SciencesJoin us for our OTC drug product monograph webinar series!

Register here for the next webinar in an ongoing series of OTC-focused webinars featuring Reed Tech subject-matter experts and some of our industry friends and colleagues.

Get your limited time trial!

Sign up for a free limited trial of Navigator™ for Medical Devices