EROMED is a 2 day workshop exclusively dedicated to the NEW European regulation imposed by the 2007/47/EC. The Workshop is organized by Obelis s.a European Authorized Representative Center & GiDoS sprl in association with MDC Medical Device Certification GmbH a German Notified Body, the Israeli Chamber of Commerce and the Israeli Export Institute. You will be taught by experts in their fields about the latest developments in the European Regulatory framework concerning Medical Devices in reference to the upcoming implementation deadline of March 21st 2010 by the 2007/47/EC.

“Spring 2010 Deadline : 2007/47/EC provisions and implementations on Medical Devices”

Workshop Dates:

– Tuesday 20th October 2009 8:30am to 6:00pm
– Wednesday 21st October 2009 8:30am to 6:00pm

The Aim of the Seminar

To present the European Regulation on Medical Devices in accordance with the MDD 93/42/EEC and its amendment the 2007/47/EC with an emphasis on the implications and implementations of the new revisions to be in full force as of 21 March 2010.

Target Audience:

– Local Importers who wish to export to Europe
– Local Manufacturers who wish to meet European standards and eventually Export to Europe

– Chief Executive Officers
– Quality Assurance/Regulatory Affairs Managers
– Export Managers
– Certification Managers

Training will consist of, among other things, the following topics:

• Essential changes in the Medical Device Directive 93/42/EEC by the 2007/47/EC
• Notified Body approach to the revised Medical Device Directive 2007/47/EC
• Authorized Representative definition, role & duties: comparative analysis
• Technical documentation
• EU Member State National Requirements for Medical Devices
• Impact of the Machinery Directive on Medical Devices
• RoHS 2002/95/EC Recast – implications on Medical Devices

Opening remarks of the workshop will be made by Dr. Nadav Shefer of the Israeli Ministry of Health – Medical Device Department Director

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