;   Medical Translation Insight: e-labeling medical devices in Europe - will it ever happen? - ForeignExchange Translations

e-labeling medical devices in Europe - will it ever happen?We have asked this before but it bears repeating: When will e-labeling become reality for devices?

And we are not the only ones asking.

Manufacturers of general medical devices have long cast envious glances at their colleagues in the IVD space. While there are challenges with providing labeling alternatives, the cost and time savings more than make up for these difficulties.

As far as general medical devices go, Medtronic has long been a proponent of e-labeling. A few years ago, the company was part of a European pilot. As reported in MDDI, the pilot found that a surprisingly large number of doctors are receptive to CD-ROM manuals. Of the 637 implanting physicians in 11 EU countries who participated in the survey, 35% said they preferred CD manuals for implants (namely, pacemakers and defibrillators) to paper manuals and 28% regarded them as equivalent and did not mind which was provided. Just 4% of doctors surveyed would not accept CDs and required paper manuals. There were no significant differences between countries.

One of the leading experts on European medical device labeling is Joachim Wilke, Medtronic's Director of Regulatory Affairs & Policy in Europe and the chair of Eucomed's Alternative Labeling Task Force. We are excited to have him hosting an audio conference on the status of the upcoming legislation on e-labeling 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 e-labeling, as well as general requirements and envisaged provisions for risk assessment, user information and Notified Body surveillance. The presentation will review topics still under discussion and provide information about the political process and expected time scenario – as well as factors which could lead to potential delays.

If your work involves European labeling, regulatory affairs, or risk management, you don't want to miss this presentation! To register, visit FXConferences.com.

ForeignExchange Translations provides specialized medical translations for medical device IFUs, operating manuals, and product labels.

1 Comment:

  1. Erik Vollebregt said...
    So far it is still under debate at the EU level and may be taken on board in the upcoming Recast of the medical devices directives. A court in the Netherlands very recently ruled that - essentially - e-labelling for AEDs is allowed in the Netherlands. See my blog at http://medicaldeviceslegal.wordpress.com/2010/11/11/reprocessing-of-single-use-medical-devices-in-the-eu/ for more information on this case. As far as I know this case will not be appealed by the parties but the authorities have informally raised suspicions about this, so perhaps I wouldn't start e-labelling for the Netherlands just yet.

    [Via LinkedIn]

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