If you were to make a device in the EU, it would be subject not to the regulatory documents required in the US but to those required in the EU. Every country has its regulating body that ensures the safety of its citizens. The EU is notably less strict than the US, and requires less thorough documentation, validation, and testing. If you wanted to sell the product in the US on US soil however, you would need to adhere to the regulating body of both the EU and US. To sell in the US you need FDA approval.