I work for a cardiovascular company that deals with an FDA classified class II medical device that is sold internationally, specifically Europe. A cardiovascular medical device that I love learning about it the pacemaker. A pacemaker is considered in the EU as an Active Implant Medical Device. It is composed of an electrical circuit which stays within the body after surgery. Both the EU and FDA classify a pacemaker as a class III device. The EU justifies this classification based on the essential requirements checklist and risk evaluation. The FDA determines the classification based on safety, efficacy and risk. Both the EU and FDA require clinical trials for supporting data in approving the active implant device. The FDA requires a PMA to be completed for the approval of a pacemaker. EU asks for a tech Dossier File for class III devices.
References:
http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=NKE