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;