MT4 Study Design Recommendations in ISO Standards for High-Risk Medical Devices: A Systematic Review of the HORIZON2020 Core-MD Project

Abstract

The role of harmonized European standards (HES) is key in the certification of medical devices (MD) in the European Union. When the product is designed and manufactured according to applicable HES, it can benefit from a presumption of conformity (MDCG 2021-5). HES are considered as reflecting the state-of-the-art in the corresponding medical field.