The answer that I am about to state is based on the links Dr. Simon posted on this week’s lecture and my understanding of the documents. The Guideline Documents are not mandatory, but they certainly provide a way to follow a directive. I would consider the NB-MED Guidance Documents to be the most useful for getting a device through the regulation process in the EU. In the EU, the Notified Bodies are capable of evaluating devices and the overall process of marketing the device. Additionally, the evaluation by a Notified Body of the products needs to include an opinion of a competent authority and they accept the Bodies’ judgment on the device. The documents state what the Notified Body will be looking for when evaluating a device, and thus, they are essential to the regulation structure because they decide whether the device passes or fails after evaluating the data gathered from the clinical studies that are conducted by the medical device manufacturers.