The one big difference in classification I see between the FDA and the EMA is the class II classification. In the US, around 25 percent of the class II devices do not go through a clinical trial, whereas the other 75 percent do. This is due to the evaluation of the actual risk of the product and the intended use. The EMA uses a scale of Class IIa and Class IIb to differentiate the between the two type of class 2 devices. This I believe is a better way to provide a ranking. Another key difference was the use of the work efficacy in the literature. This is a very important part of any device and it’s interesting the see the difference in roles of the two governing bodies, even though both bodies are effective, the EMA seems to have more of a checklist sort of regulation. Which can be faster and cheaper to go through then the FDA. Which explains the inclination of companies to used the data from EMA trials to support FDA approval.