Roadmap to CE marking

A roadmap for getting your product CE marked might look like this:
  1. Identify the applicable EU directive;
  2. Determine the classification of the medical device (Annex IX)
  3. Determine the route to CE marking;
  4. Implement the EU directive;
  5. Implement the quality system requirements;
  6. Report medical devices in class I to the Competent Authority;
  7. Obtain approval from a notified body for Class Is, Im, IIa, IIb or III;
  8. Place the CE logo on the products (Annex I, item 13);
  9. Sell the products;
  10. Actively collect experiences with the product  from the market and implement necessary improvements;