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Sponsored Webcast: Update Your Medical Device UDI Data and Labels: This Year FDA Class I / Next Year EU MDR

1.0
RAC Credits
Wednesday, 17 June 2020 (10:00 AM) - Wednesday, 17 June 2020 (11:00 AM) Eastern Time (US & Canada)


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 an interactive webcast focused on two compliance areas they are monitoring closely. The webcast will review what you need to know and do right now to address the following:

US FDA September 24, 2020 -- 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?

The presenters will review and provide clarity on currently posted guidance and answer questions from attendees. The webcast will focus specifically on:

  • The US FDA label and data reporting requirements due 24 September 2020 for Class I devices
  • The EU MDR label and data reporting requirements due 26 May 2021
  • The differences and similarities of FDA and EU Unique Device Identification (UDI)
  • How the COVID-19 driven shift to remote, cloud-based labeling eases compliance
  • The advantages of a comprehensive, global strategy for UDI and labeling compliance


Learning Level(s)

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.


Learning Objectives

Upon conclusion of the program, you will be able to:

  • The US FDA label and data reporting requirements due Sep 24, 2020 for Class I devices
  • The EU MDR label and data reporting requirements due May 26, 2021
  • The differences and similarities of FDA and EU Unique Device Identification (UDI)
  • How the COVID-19 driven shift to remote, cloud-based labeling eases compliance
  • The advantages of a comprehensive, global strategy for UDI and labeling compliance


Who Should Attend

  • Unique Device Identification Team Members
  • Product Labeling Team Members
  • Global Strategy Business Managers
  • Regulatory Affairs/Operation Leaders
  • Product Managers and Business Analysts
  • Manufacturing, Operations, and Supply Chain Leaders
  • Quality Leaders
  • Medical Device IT Support


Speaker(s)


  • Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech

Gary Saner is a subject matter expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management and data administration with the last 15 years focused on the life sciences industry. With an understating of regulations, business requirements and systems, he has helped shape and implement solutions at Reed Tech for data management, validation and processing of drug labeling and medical device unique device identification content. He serves as Co-Chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.


  • Lee Patty, VP & GM, NiceLabel

Lee Patty is VP and General Manager at NiceLabel Americas where he oversees the company’s sales, project delivery and operations in the Americas. Over his 25-year career, Lee has worked with life sciences companies to improve their labeling process while meeting industry regulatory requirements. Prior to NiceLabel, he co-founded Niceware International, LLC, a NiceLabel distributor, where he was responsible for marketing, healthcare product development and professional services. NiceLabel acquired Niceware in 2013 and added Lee to the global executive team. Lee has 25 years of AIDC industry experience.

Register