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Overview: Medical devices sold into the European Union (EU) must comply with the applicable medical device directives, EU laws similar to FDA's regulations. Medical devices declared compliant must bear a CE mark in order to be admitted into the 29 member countries comprising the EU. The market population of these 29 countries is 450 million people, exceeding the 420 million people served by NAFTA (USA, Canada & Mexico), so many companies have an interest in penetrating this market. This presentation will provide an explanation in layman's terms of the various routes to CE marking of medical devices, with a focus on the Medical Device Directive, MDD 93/42/EEC. Areas Covered in the Session: New approach directives & background IVD, MDD & Active Implantable Directive Competent Authorities & Notified Bodies Medical Device Directive Device classification Routes to CE marking under various MDD annexes Technical files Essential requirements checklists ISO 13485:2003 Quality System Certification Who Will Benefit: Companies wishing to penetrate the EU market for medical devices or sharpen their skills will receive practical guidance on achieving the CE mark. Employees who will benefit include: Quality & Regulatory Professionals Manufacturing & Design Engineers Marketing Product Managers John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union's medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has been performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004 Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference. AMAZINES.COM
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Online Training, CE, FDA, EU-Medical Device, MDD 93/42/EEC, IVD, NAFTA,
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