PSUR

A systematic review of the literature, including both peer-reviewed and grey literature (e.g., conference abstracts), is recommended as part of a clinical evaluation report or CER and the post-market surveillance of medical devices.   The [...]

Every medical device on the European market must be continuously monitored to confirm its safety and efficiency for patients and users. The EU MDR (2017/745) requires clinical evaluation and post-market surveillance programs to ensure [...]