IMDRF Offers Final Clinical Guidelines

The International Medical Device Regulators Forum (IMDRF) has released three final documents addressing clinical evaluation requirements for medical devices, including in vitro diagnostics and software as medical devices. These publications provide clarity on when clinical investigations are necessary and emphasize the importance of maintaining updated clinical evidence throughout a device’s lifecycle. These new documents replace earlier versions issued by the Global Harmonization Task Force (GHTF).

Clinical Evaluation

The Clinical Evaluation guidance is intended to help manufacturers plan, conduct, and document the clinical evaluation of a medical device as part of conformity assessment prior to market placement and throughout post‑market activities. It also aids regulators and other stakeholders in assessing the adequacy of the clinical evidence provided.

This document provides direction on:

• Fundamental principles of clinical evaluation 
• Methods for identifying relevant clinical data 
• Approaches for appraising and synthesizing clinical data 
• Proper documentation of the evaluation within a Clinical Evaluation Report (CER)

The guidance applies to medical devices other than in vitro diagnostic devices (IVDDs).

Clinical Investigations

The Clinical Investigation guidance outlines:

• Circumstances under which a clinical investigation is required to demonstrate conformity with the Essential Principles (as referenced in IMDRF/GRRP WG/N47 FINAL:2018) 
• General principles for conducting clinical investigations involving medical devices 

Given the broad diversity of medical devices and associated risk profiles, the document does not provide detailed device‑specific instructions. Although primarily developed to support marketing authorization submissions, some sections may also apply to post‑market studies conducted after commercial release. The guidance does not apply to IVDDs.

Clinical Evidence

The Clinical Evidence document aims to:

• Introduce key concepts related to clinical evaluation and evidence generation 
• Explain the relationship between clinical investigations, clinical data, clinical evaluation, and clinical evidence 
• Provide direction for regulators, conformity assessment bodies, manufacturers, and industry groups involved in creating, compiling, or assessing clinical evidence for device marketing 

The definitions and principles outlined apply broadly to the demonstration and maintenance of conformity with Essential Principles for medical devices. Additional specific guidance exists for in vitro diagnostic devices.

Together, these IMDRF documents promote a harmonized approach to clinical evaluation, evidence development, and investigation requirements for medical devices globally. Vices.