2. - Another type of adverse events, in particular regarding defects of medical devices that could have led to a serious adverse event and new data on any adverse event is recorded and notified National Authorities, INFARMED (National Authority of Medicines and Health Products, IP) and CEIC (National Ethics Committee for Clinical Research), within a period of seven days, starting from the moment they become aware of them. All supervening information considered relevant by the competent authorities will be notified within eight days from the closing date provided for in the preceding paragraph.