eLabeling Medical Devices for the EU Market

is being presented by Salma Michor, CEO and Principal Consultant, with Michor Consulting EU and airs on Tuesday, January 10th, 2012. For more details, or to register please visit our site at www.fxconferences.com

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. Originally e-labeling focused on IVDs, since these are usually used by healthcare professionals in a clinical environment, however, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce amendments pivotal for e-labeling for other devices.

In order to set up an e-labeling system, companies must develop and implement internal controls and procedures that promote adherence to regulatory requirements including applicable statutes, laws, regulations and directives. e-labelling provides several advantages in managing regulatory compliance but also poses some challenges. 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 to gain competitive advantage.

eLabeling for Medical Devices in the EU

is being presented by Joachim Wilke, Director, Regulatory Affairs & Policy, Europe
, with Medtronic and airs on Wednesday, November 24th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Get the very latest on European device labeling, from one of the architects of the legislation!

This audio conference discusses the background and status of the upcoming legislation on elabeling for medical devices in the European Union. Based on the most recent available EU Commission draft, it covers the scope of medical devices being considered for elabeling, as well as general requirements and envisaged provisions for risk assessment, user information and Notified Body surveillance. Our speaker, who chairs Eucomed's Alternative Labeling Task Force, also reviews a number of topics still under discussion, and provides information about the political process and expected time scenario – as well as factors which could lead to potential delays. The presentation also raises some practical considerations on the implementation of elabeling for medical devices.

EU Medical Device eLabeling, Compliance & Software Requirements

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.

EU Medical Device eLabeling, Compliance & Software Requirements is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Wednesday, January 13, 2010. For more details or to register, please visit our site at www.fxconferences.com