EU MDR: Best Practices for UDI Data & Product Labeling

Medical Device, Medical Device Safety and Regulation, Medical Device Manufacturing & Supply Chain,
  • Thursday, February 20, 2020

According to a recent survey*, most manufacturers realize the significant effort to transition from the EU Medical Device Directives to the Medical Device Regulation (EU MDR) and are continuing their EU MDR preparation activities.

They understand:

  1. The EU MDR “process” is not delayed
  2. EU MDR compliant products must meet new labeling requirements as of the Date of Application (DoA) and
  3. EU MDR documentation and device registration previously expected to be reported to EUDAMED must still be reported per corresponding Directive provisions in the two-year delay period

Accordingly, best practices are being followed for creating structured device registration and Unique Device Identification (UDI) data and for implementing EU MDR compliant product labels in order to comply with the EU MDR DoA requirements.

 In this free webinar, featured speakers from Reed Tech and PRISYM ID will discuss what device companies will need to do to be EU MDR compliant. The discussion will focus on device registration, UDI data management and product labeling. Other topics include EU MDR timing deadlines, best practices in creating and submitting product data and best practices in preparing and maintaining compliant labels not only for EU MDR, but for the upcoming regulations, too.

*Survey information

Speakers

http://Gary%20Saner,%20Reed%20Tech

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 the areas of 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.

Message Presenter
http://Richard%20Castle,%20PRISYM%20ID

Richard Castle, Global Account Manager Medical Device, PRISYM ID

Having spent most of his career working within the print sector and enterprise-level labeling software, Richard Castle is always keen to learn about the regulatory labeling changes the industry faces, like EU MDR, and to share his gained knowledge.

Richard is aware of the complex selection process for labeling solutions that customers experience, and he has a proven ability to align their requirements to solutions that are not only valid for today but aligned to any future impact of regulatory changes.

Message Presenter

Who Should Attend?

This webinar will be suitable for individuals with the following or related job titles: 

  • Unique Device Identification (UDI) 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 Personnel

What You Will Learn

Attendees will learn about: 

  • The known timing and requirements of EU MDR device registration and product labeling
  • Best practices in creating, managing and submitting EU device registration and UDI information
  • Best practices in implementing EU MDR compliant product labeling
  • The importance of controlling the data

Xtalks Partners

Reed Tech

Reed Tech is the provider of best-in-class data management, conversion, information, and analytics solutions to government agencies, patent-driven companies and law firms, and the life sciences industry. Our solutions offer the means for our customers to increase productivity, comply with regulations and make more informed decisions quickly. Our offerings enable the collection, transformation, submission and analysis of data. The corporate culture is driven by a commitment to excellence, innovation, and a strong dedication to customers, employees and communities. Reed Tech is a LexisNexis® company. For more information, please visit ReedTech.com.

Life Sciences Solutions Driven by Accuracy and Insight

Reed Tech offers product and service solutions to help Life Sciences professionals gain control over their own and their industry’s data. Our offerings smooth the collection, transformation, submission and analysis of regulatory data for manufacturers and distributors of medical device and drug products, and for those who support them in consulting and IT roles.

PRISYM ID

World Class Label Management Software

PRISYM ID designs and delivers label management software for organizations that need complete product auto-identification and lifecycle traceability. With the continual tightening of labeling regulations and audits, PRISYM ID empowers its clients to safeguard their reputation by ensuring compliance, removing risk and significantly reduce costs by eliminating recalls through labeling errors. PRISYM ID is the market leader in providing validatable world-class label lifecycle management, and is trusted for delivering personalized service excellence to clients.

Medical Device

We help our customers to achieve the most rigorous demands of labeling compliance: FDA 21 CFR Part 11, EU MDR, FDA UDI , FDA 21 CFR 820; to increase their operational efficiency through a single source of truth and to maintain their data integrity.

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