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