There are differences in regulatory approach between the EU and the U.S.. Therefore; there are differences in device classification and we can not assume that meeting the requirements for the U.S. market would satisfy the EU requirements. Another example of a medical device that is classified in US and EU differently is hospital beds. According to FDA guidance, hospital beds including accessories are either Class I or II depending on the type of bed. In the EU, hospital beds and accessories are classified as Class I devices, allowing self-certification. In addition, the beds and their accessories would have to be considered separately, each as medical devices in their own right, especially when such items are sold separately.