You need to gather and monitor any information regarding the experience of the device. This include, for example:
- Feedback about patient clinical benefits
- Feedback about indications for use
- Knowledge of new performance trends
- Knowledge of long-term performance, reliability and chronic complications
- Knowledge of performance in different population of users
- Feedback about use with other devices, accessories and substances
- Confirmation (or not) of risk analysis
- Knowledge of ways in which the product is incorretly applied
- Information of incidents related to the products
- Identification of surveillance reports
- Feedback about instructions for Use
- Feedback about necessary training for users
These are all information that needs to be part of your post market surveillance system. This also has to be active (as the standard required the information to be gathered), instead of only reactive (as is the case of complaints).