CE Mark Required to Sell Medical Devices in The EU

Vidia Ramdeen

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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.

Course Objective

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.

Course Outline

  • 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

Target Audience

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

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Vidia Ramdeen,

Vidia Ramdeen MPA SSBB is a research consultant with experience across a broad array of industries including health care, medical, biomedical, and biotechnology. In addition, his research experience includes strategy, innovation, leadership, solutions-based, and management consulting. His knowledge of compliance issues is a function of consulting responsibilities that provide a fundamental base to analyze today’s complex compliance environment.

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