I interpret as: the data you produced pre-market doesn't cover the full lifecycle of your device.
Example: you have an implant with a lifecycle lasting 20 years but your had only 2 years follow-up data when placing the device on the market, hence the need to complement your clinical data with studies recording a longer follow-up.
Example: you have an implant with a lifecycle lasting 20 years but your had only 2 years follow-up data when placing the device on the market, hence the need to complement your clinical data with studies recording a longer follow-up.
