Chapter VII - Post-Market Surveillance and Vigilance

Chapter VII of the Medical Device Regulation (EU) 2017/745 sets out the requirements for post-market surveillance and vigilance. It obliges manufacturers to establish systematic procedures for collecting and analysing data on device performance after it is placed on the market, and to report serious incidents and field safety corrective actions to the competent authorities. The chapter aims to ensure ongoing safety and effectiveness of medical devices throughout their lifecycle.