Hamburg, 16th December 2020, Dr. Peter Wirthschaft

The WHO Division of Access to Medicines and Health Products has published a guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics that takes recent regulatory developments such as the IVDR, MDR or ISO/TR 20416:2020 into account to formulate a framework for conducting post-market surveillance. The guidance covers the objectives and processes of post-market surveillance activities by manufacturers and regulators with emphasis on measures to ensure medical devices meet the requirements for safety, quality, and performance after they have been placed on the market.