I would like to point out that post market surveillance can also be conducted on clinical studies. The importance of Post Market Clinical Follow Up (PMCF) studies is to try to identify and investigate any enduring risks that are associated with medical devices on the market. This may be needed because of certain risk factors, procedures, population, safety, any significant changes to the device. Granted, due to established data in terms of safety that is conducted during clinical trails and the product already being brought to market, the PMCF is not always required. However, medical device manufacturers are still required to explain the justification as to why the PMCF is not conducted or performed.