In Depth: Europe medical device approval and compliance


Europe is the world's second-largest medical device market with 500 million people. It is made up of 28 member states (and growing) and has 20+ languages. Fortunately there is one approval process for medical devices. In this seven part slidecast we will demystify the process of bringing your device to market in the EU, breaking it down into understandable steps and explaining each one. Once you begin the series you may skip to the next section at any time using the Playlist in the player window. Information current as of October2014.

  1. Overview of the CE Marking framework [runtime = 4:40]
  2. Classifying your medical device [runtime = 3:36]
  3. QMS requirements [runtime = 2:19]
  4. Preparing a Technical File [runtime = 4:17]
  5. Key players in the CE Marking Process [runtime = 2:58]
  6. Final Steps [runtime = 3:10]