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 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.
CE Marking
Instructor: John Chapman
Product ID: 500511

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.

Objectives of the Presentation:
  • 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
Who can Benefit:
  • Companies wishing to penetrate the EU market for medical devices or sharpen their skills will receive practical guidance on achieving the CE mark.
  • Quality & Regulatory Professionals
  • Manufacturing & Design Engineers
  • Marketing Product Managers
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
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Live Session - How it works
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  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
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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