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The International Medical Device Regulators Forum (IMDRF) released three final documents covering clinical evaluation of medical devices, in vitro diagnostics and software as medical device products; insights on when a clinical investigation is necessary; and the need for clinical evidence to be updated throughout the life cycle of a device. These are replacing earlier versions of the documents developed by the Global Harmonization Task Force (GHTF).

Clinical Evaluation:

The Clinical evidence document intends to provide the manufacturers on how to conduct and document the clinical evaluation of a medical device as part of the conformity assessment procedure prior to placing a medical device on the market as well as to support its ongoing marketing. It is also intended to provide guidance to regulators and other stakeholders when assessing clinical evidence provided by manufacturers.

This document provides the following guidance:

• General principles of clinical evaluation;
• How to identify relevant clinical data to be used in a clinical evaluation;
• How to appraise and integrate clinical data into a summary; and
• How to document a clinical evaluation in a clinical evaluation report.

The guidance contained within this document is intended to apply to medical devices other than IVDDs. 

Clinical Investigations:

The clinical investigation guidance is provided with the purpose of:

• When a clinical investigation should be undertaken for a medical device to demonstrate compliance with the relevant Essential Principles (see IMDRF/GRRP WG/N47 FINAL:2018 “Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices”); and
• The general principles of clinical investigation involving medical devices.

Given the wide diversity of medical devices and their associated risks, this document is not intended to provide comprehensive guidance for clinical investigations of specific medical devices.

The guidance contained within this document is intended to apply to medical devices other than IVDDs. Additionally, this document was drafted primarily to address the use of Clinical Investigations to support a marketing authorization application. Some aspects of this document may apply to studies conducted following commercial release of a medical device.

Clinical Evidence:

The Clinical evidence document intents to:

• Introduce the concepts of clinical evaluation and clinical evidence;
• Examine the relationship between clinical investigation, clinical data, clinical evaluation and clinical evidence; and
• Serve as guidance to all those involved in the generation, compilation and review of clinical evidence sufficient to support the marketing of medical devices (regulatory authorities, conformity assessment bodies, manufacturers of medical devices and their associated industry groups).

The definitions and concepts contained within this document are intended to apply to the establishment and maintenance of conformity with the relevant Essential Principles for medical devices generally. Specific guidance has been developed in other documents in relation to in vitro diagnostic devices.