CE Mark - Required to Sell in the European Market

Duration: 60 Minutes
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 27 member countries comprising the EU. The market population of these 27 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.
CE Marking of Medical Devices
Instructor: John Chapman
Product ID: 501636
Objectives of the Presentation
  • Current requirements of MDD 93/42/EEC for CE Marking
  • Brief summary of MDD changes expected in 2016
  • New focus on the role of Notified Bodies & why
  • Brief discussion of ISO 13485:2006 (mandatory in 2009)
  • A better understanding of the requirements
Why Should you Attend
Companies wishing to penetrate the EU market for medical devices or sharpen their skills will receive practical guidance on achieving the CE mark.

Areas Covered
  • 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
  • ISO 13485:2003 Quality System Certification
  • Changes coming summary
Who will Benefit
  • Quality & Regulatory Professionals
  • Manufacturing & Design Engineers
  • Marketing Product Managers
  • Program Managers
Topic Background
CE marking of all medical devices is required before shipment into most of the European countries. Technical documentation requirement for obtaining the CE mark is similar for shipment into Canada and is rapidly expanding to other countries.
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Instructor Profile:
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 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 2004Fundamentals 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.

John has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, Auditing, Root Cause Analysis, Design Control, Bloodborne Pathogens, Hazardous Waste Handling, and FDA regulations. He has also presented live on-line seminars on various regulatory subjects.
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