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.
This webinar will explore the many benefits, as well as the compliance and business requirements of 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:
What is eLabeling and why should I care?- Increasing drivers of change in IFUs
- Benefits of eLabeling
- Examples of eLabeling successes
- Worldwide overview of eLabeling acceptance
- Products eligible for eLabeling in Europe
- Countries and languages required in Europe
- EU requirements for eLabeling
- Risk assessment
- Insert
- IFU
- Package symbol
- Website
- Paper IFUs on demand
- EU Change Notification
- Business considerations
- Key business decisions
- Potential challenges and some solutions
- Where to start - legacy vs. new products
- Potential outsourcing decisions
Who Will Benefit:
- Regulatory managers
- Supply chain managers
- Operations managers
- Labeling managers
- Packaging managers
- Information technology managers
Course Provider
Daphne Walmer,
