MDCG 2022-2: Recommended Strategies for Data Retrieval and Literature Reviews
On January 27, 2022, MDCG 2022-2: “Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)” was published. This document provides information for manufacturers, regulators, investigators, sponsors, Notified Bodies and other industry stakeholders concerning the continuous process for IVD performance evaluation.