From my experience, the company that i work for proceeded with releasing their medical device which is a vision testing device for diagnosis and early detection of retinal pathologies. The device was first submitted to obtain a CE Mark and released after following the checklist associated to the MDD (Medical Device Directive). This device is considered a Class IIa since it is a device that measures electrical impulses produced by the visual cortex and retinal cells. The EU procedure in getting a medical device approved is much easier and as a buisness standpoint, far better considering it opens the market to sell the device in the rest of Europe. Comparing this to the FDA’s standards and requirements, the process would be much longer and cumbersome since this same device would be considered a Class II and require a 510K since it is working from a predicate existing technology and device in the market. Following the 510K requires an extensive procedure to follow, this is because the FDA heavily focuses on the safety and efficacy of the device and the patient’s well being.