Publication of the “Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)”

Posted on 02.02.2022

On 27 January 2022, the European Commission’s Directorate-General for Health and Food Safety published the Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs). The document is intended for IVD manufacturers, investigators, study sponsors, regulators, notified bodies and other stakeholders.

The document provides insights on the general aspects of clinical evidence, including considerations on scientific validity, analytical and clinical performance, state of the art. It highlights that performance evaluation is a continuous process within the life cycle of an IVD, and risk management is part of that process.

The MDCG Guidance and MedTech Europe’s ebook constitute a comprehensive information package for the IVD industry to rely on for the clinical evidence requirements under IVDR.