Introduction to CE Marking

Get all the information you need to start your CE Marking journey.

We answer your questions on our Introduction to CE Marking course, helping you to make informed decisions about your medical devices.

Find out what action is needed to remove uncertainty from the EU regulatory process – we explain the CE Marking process and routes to compliance with the EU Medical Devices Directive, outlining the role of clinical data in identifying and managing risk.

And you will discover how all of this can open up new business opportunities in the EU market.


Who should attend?

  • Senior management
  • Regulatory, quality, design, development, manufacturing and marketing managers and teams
  • Organizations preparing own branding or private labelling for devices

What will I learn?

  • Understand the European Medical Devices Directive and CE Marking
  • The role of EU risk classification and quality assurance in achieving compliance
  • Essential requirements of CE Marking and how to achieve them
  • The role of clinical data and risk management in medical devices reporting

Prerequisites

We recommend you have basic knowledge of the medical devices industry, but there are no formal prerequisites for this course

How will I benefit?

  • An understanding of CE Marking across your organization
  • Know how to design safe and quality products for the EU market
  • Customer and industry confidence as you introduce CE Marking
  • Ability to access EU market and new business opportunities