Since 2015 and the change of the regulation regarding clinical investigation in Spain, Post-Market study should be notified to AEMPS according to RD 1090/2015, Third additional provision, point 3. “The start of clinical research with medical devices bearing CE marking and which are used for the same indications included in the conformity assessment procedure shall be notified to the Spanish Agency of Medicines and Medical Devices whenever any intervention modifying standard clinical practice is performed in these investigations.” (unofficial translation reviewed by AEMPS). This is a very simple notification that should be done once the EC approval is obtained. The notification consist of sending a letter to AEMPS and attached the EC approval.