Major Changes to the Medical Devices Directive 93/42/EEC as Amended by 2007/47/EC (On-Demand Webinar)

Description

This one-hour on-demand webinar, recorded on December 3, 2009, is intended to provide an overview of the major changes to the Medical Devices Directive 93/42/EEC as amended by 2007/47/EC, which is mandatory March 21, 2010.

EU Directive 2007/47/EC is an amending directive and the changes documented within it are a significant update to the Medical Devices Directive 93/42/EEC and will impact all manufacturers that sell, or plan to sell, medical devices in Europe and potentially other countries of the world that currently recognize and accept CE marking as a means of market entry into their own territory. The changes become mandatory for manufacturers selling Medical Devices in the EU March 21, 2010.  This live webinar provides the opportunity to hear the Notified Body perspective on the major changes delivered from the UK by a senior Notified Body engineer at Underwriters Laboratories®.

Topics covered in this webinar include:

• Overview of the changes to the Medical Devices Directive
• Changes in Sampling requirements
• Drivers for change  
• Structure of the directive and how to identify changes
• What UL Notified Body Assessors may be looking for both now and after March 2010

Objectives

• Identify the major changes in the new Medical Devices Directive 93/42/EEC
• Understand what the auditors may be looking for
• Understand why your Notified Body may ask for additional documentation on existing certifications
• Review your own system for areas that may be affected
• Set an action plan for compliance by the Mandatory deadline

Target Audience

• Regulatory affairs professionals
• Managing directors
• Regulatory consultants

UL University's workshops are designed for and intended to serve individuals using and relying upon UL services. UL University reserves the right to limit workshop attendance strictly to the foregoing. In addition, UL University reserves the right to change, reschedule or cancel any workshop at any time. UL shall not be responsible for any consequential or other losses resulting from the cancellation or postponement of this workshop such as airline and other travel/personal expenses.

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