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FDA and EU Medical Device Labeling Requirements Training

When it comes to medical devices, the term labeling encompasses much more than a label – it refers to a set of materials and information about your device. Major regulatory bodies enforce specific requirements to ensure that medical device labeling meets certain standards, and compliance with these requirements is a legal obligation for manufacturers as long as the device is on the market. This class covers the concepts that underpin medical device labeling (usability, risk, and misbranding) and the practicalities of implementing labeling processes. 

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Brief Overview of This Class on Medical Device Labeling Requirements

SkillsLab Class ?

Class Content

In-Depth

Class Duration

4 Half-Days

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person

Certification of Completion

Yes

Continuing Education Units (CEU)

1.6

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 2 consecutive days. 

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming Training Classes on FDA and EU Labeling Regulation

SkillsLab $2195

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

Here's What We Cover in This Medical Device and IVD Labeling Class

This course provides a foundation for medical device labeling in accordance with US FDA and EU requirements. Learn about mandatory label content and accompanying information, as well as best practices for symbols, translations, and Unique Device Identification (UDI).

Course Overview
SkillsLab Class

Introduction to Labeling

  • Labeling terminology, definitions, and components
  • Introduction to EU and FDA labeling regulations and standards
Exercise! What Is Labeling?
Exercise! What Are the Labeling Components?
Exercise! What Do the Regulations Cover?

Labeling Components: What to Include and How

  • General labeling requirements
  • Required elements for marking and labels
  • Required elements for packaging and IFUs
  • Symbols use and meaning
  • Language translations
  • Unique Device Identifier (UDI)
  • E-labeling
Exercise! What Is Missing From the Label?
Exercise! What Is Needed for the Packaging?
Exercise! What Is Missing From the IFU?
Exercise! UDI Placement
Exercise! Translate Label Text Into Symbols

Concepts to Consider

  • Risk
  • Usability
  • Misbranding and claims
Exercise! Evaluate an IFU
Workshop! Misbranding and Off-Label Promotion

Processes and Application

  • FDA submission, EU registration, and UDI database registrations
  • Labeling creation and responsibilities
  • Testing and validation
  • Assessments and updates
  • Best practices
Exercise! Does It Need a Number?
Exercise! Labeling Change Process
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

Seek and obtain labeling guidance from appropriate standards and regulations given the target market and device details

Define labeling terminology and components (marking, labels, packaging, instructions for use) and the required elements of each

Meet requirements and make best use of electronic documents, UDI, symbols, and translations in labeling

Describe the roles of usability, risk, and claims in labeling, and consider them in design and decision making

Implement successful, efficient labeling design and production processes

Who Should Attend

Who Should Attend

This course is intended for those who are involved in the creation, approval, and revision of labeling and promotional material for medical devices in the US and/or the EU.

  • Labeling Managers
  • RA/QA Personnel
  • Marketing Personnel
  • Production Managers
  • Internal Auditors 

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