Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. Currently, most Instructions for Use are provided in paper format, which can be very lengthy. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. This is especially the case with IVDs, since these are usually used by healthcare professionals in a clinical environment, with relatively common access to computers and Internet facilities.

However, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.

This audio conference covers:

• The complexity and importance of regulatory compliance
• Advantages of using e-labeling
• Challenges of using e-labeling
• e-Labeling of IVDs
• e-Labeling of other medical devices

About the speaker:

Salma Michor, PhD, acts as an independent expert for the European Commission, evaluating industrial and other research projects. She teaches Regulatory Affairs and Clinical Strategies at two MBA courses offered by the University of Krems in Austria. Before starting her own consulting business, Michor Consulting EU, Salma worked in regulatory with Chiesi-Torrex and Wyeth Whitehall Export. In her last role as Director of Supporting Operations at Croma Pharma GmbH, she supervised diverse departments, including regulatory affairs and compliance, change control, pharmaceutical editing and pharmacovigilance, vigilance and medical writing.

Salma received her PhD in Thermal Process Engineering and her MSc in Food & Biotechnology from the University of Applied Life Sciences in Vienna, Austria, as well as an MSc from King’s College London in Food Technology. Salma holds the EU RAC and is completing her MBA with Open University in the UK. She is also a member of the RAPS Board of Editors for Regulatory Focus magazine and serves on the RAPS European Committee.

Who should attend?

• Regulatory Affairs
• Quality Assurance
• Project Coordinators
• Packaging Technologists
• Artwork and Labeling
• Safety Officers and Managers

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.