Overview of the CE Mark Approval Process for Medical Devices

Shown below is an overview of the CE approval process for medical devices sold in Europe. This is a simplified version of the CE Mark certification process but it applies to most medical device and IVD companies. Watch our 11 minute presentation on the CE Marking process in Europe or download our PDF chart similar to the one shown below that shows the European regulatory process.

Emergo Group can assist you with all aspects of the CE approval process for medical devices. Please see our page on CE Mark certification consulting for more information.