EU MDR: Best Practices for UDI Data & Product Labeling
According to a recent survey*, most manufacturers realize the significant effort to transition from the EU Medical Device Directives to the EU Medical Device Regulation (MDR) and are continuing their MDR preparation activities.
- the EU MDR “process” is not delayed
- EU MDR compliant products must meet new labeling requirements as of the Date of Application (DoA) and
- 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 medical 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.
Key Learning Objectives:
- 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
MEET OUR SPEAKERS
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 is always keen to learn about the regulatory labeling changes the industry faces, like EU MDR, and 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.
Gary Saner, Sr. Manager of Information Solutions, Reed Tech
Gary 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.