It is easier to get devices approved in the EU because it requires less data and evidence compared to FDA. For example, FDA would require an actual study based on a big sample where in EU, you may be able to get it approved on pilot data. Other factors include that FDA is a directly under the government and in EU a private company is chosen and they independently do their own vetting on the devices. As well as their device classification, timelines, process, cost, and results differ greatly. EU results gives market access vs FDA gives exempt, clearance, or limited clearance even if the device is approved. So If I were to bring a device on the market, I would first launch the device in EU for better business and later in the FDA because of the strict rules and regulations and getting a partial result even after following the rules and regulations.