ComplianceOnline

eLabeling for Medical Devices: Valuable but not easy

Instructor: Daphne Walmer
Product ID: 704912
  • Duration: 90 Min

recorded version

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This webinar will explore the benefits of internet-based manuals/IFUs (instructions for use), as well as the products that are eligible to replace paper manuals with internet-based manuals, along with the compliance and business requirements for implementing eLabeling.

Why Should You Attend:

Since 2002, the US law and FDA regulations have allowed medical device companies to distribute instructions for use (IFUs) for prescription medical devices via the internet rather than in paper. Clinicians, companies, and regulatory bodies have reaped considerable benefits as a result. Starting in 2013 European Commission Regulation 207/2012 allows manufacturers of certain types of medical devices to replace paper with internet as the primary means of delivery. Some companies are adding IFUs to the internet even when they cannot remove paper IFUs from packages. The many potential benefits of eIFUs include 24/7 access to the latest information, facilitation of worldwide growth, cost reduction, and faster compliance with new labeling requirements. However, the EU imposes significant compliance requirements for eIFUs.

This webinar will explore the many benefits, as well as the compliance and business requirements of implementing eLabeling.

Learning Objectives:

  • To understand the benefits of internet-based manuals/IFUs (instructions for use)
  • To know which products are eligible to replace paper manuals in packages with manuals on the internet
  • To understand what is required of manufacturers to comply with 207/2012
  • To be aware of the business requirements to implement internet-based manuals
  • To be aware of what to measure in order to estimate the cost to implement internet-based manuals
  • To be aware of some of the best practices for internet-based manuals

You will be able to answer the following questions without saying, “I don’t know.”

  • How might my company benefit from having our manuals/IFUs on the internet?
  • What does my company need to consider while looking at the decision to go to eIFUs?
  • What types of products are eligible for replacing paper manuals with internet-based manuals?
  • What is necessary to obtain approval in the European Union for replacing paper with eIFUs?

Areas Covered in the Webinar:

  1. What is eLabeling and why should I care?
  2. Increasing drivers of change in IFUs
  3. Benefits of eLabeling
  4. Examples of eLabeling successes
  5. Worldwide overview of eLabeling acceptance
  6. Products eligible for eLabeling in Europe
  7. Countries and languages required in Europe
  8. EU requirements for eLabeling
    1. Risk assessment
    2. Insert
    3. IFU
    4. Package symbol
    5. Website
    6. Paper IFUs on demand
    7. EU Change Notification
  9. Business considerations
  10. Key business decisions
  11. Potential challenges and some solutions
  12. Where to start – legacy vs. new products
  13. Potential outsourcing decisions

Who Will Benefit:

  • Regulatory managers
  • Supply chain managers
  • Operations managers
  • Labeling managers
  • Packaging managers
  • Information technology managers

Instructor Profile:

Daphne Walmer is a former Director of Technical Communications at Medtronic who pioneered the use of electronic manuals in the medical device industry. Her group obtained approval to test eIFUs in the European Union for 10 years before their approval in 2013. She helped review the EU regulation for the industry, and led the effort for Medtronic to comply with its requirements. She currently consults in the areas of management of user documentation, translation and localization, and component content management systems.

Topic Background:

Keeping manuals/IFUs current is a challenge for medical device companies, especially for the European Union. Periodic CE renewals often come with requirements to change labeling to comply with new or updated standards, medical procedures, addresses, and other changes. Requirements for new information based on RoHs (restriction of hazardous substances), WEEE, and other new warnings drive also updates to IFUs. Also, as manufacturers broaden their sales efforts into new countries, additional languages are required, and adding those new languages to existing packaging takes time. Pushing all the changed IFUs through medical device inventory throughout the supply chain can take 6-12 months.

Making manuals available on the internet can ease the implementation of some of these requirements, as well as providing 24/7 access to the newest information. Furthermore, customers are coming to expect to find information they need online, basing their expectations on instant availability of information for consumer products, as well as many other products.

This webinar will explore these and other benefits of internet-based manuals/IFUs, as well as the products that are eligible to replace paper manuals with internet-based manuals, along with the compliance and business requirements for implementing eLabeling.

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