I do agree that the EU has an easier system to approve the medical devices than the FDA approval. Initially all the countries in Europe had their respective rules and they all had to give up their individual rights for approving medical devices to be able to join the EU. With this combination of rules, the various countries came to an agreement with all of the countries approval. However, the FDA was created based on products that were made with false labeling and ultimately harming people. And over time, regulation was put in place as more complex devices required to have additional efficacy testing to ensure the safety of the United States. And with that seeing that the FDA works to check for safety and efficacy while the EU identifies its devices based on the risk level.