News
August 21, 2008
John Webster to Chair Session and Present on EU Regulatory Requirements for Medical Devices
August 21, 2008, North Attleboro, MA – The Active Implantable Medical Devices Directive (AIMD), Medical Devices Directive (MDD), In Vitro Diagnostic Devices Directive (IVDD) and the CE Mark http://www.mdci.com/services/regulatory/ce-compliance-ce-mark.php were developed to drive harmonization of regulatory requirements. But, has this really happened? The CE Mark is no longer the only regulatory hurdle required to market devices in Europe.
Mr. John Webster, Managing Director of MDCI Ltd. will chair and present, "National Regulatory Requirements for EU: Beyond the CE Mark", on September 15, at the 2008 RAPS Annual Conference & Exhibition in Boston, MA.
Along with co-presenters Roger L. Gray, Director Global Regulatory Affairs, Donawa Consulting Srl and Marc-Henri Winter, Executive Manager, G-MED North America, Inc., Mr. Webster will explore why these initiatives have not been effectively implemented. The panel will also examine the current regulatory requirements driven by individual countries, including registration and vigilance differences, and the ramifications of these requirements on the global marketplace for medical devices.
Visit www.raps.org for additional information.
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