New guidelines on clinical evidence, clinical investigation and clinical evaluation

The International Medical Device Regulators Forum (IMDRF)* published three new documents addressing clinical evaluation, clinical investigation and clinical evidence. Documents shall offer guidance to all those involved in the generation, compilation and review of clinical evidence sufficient to support the marketing of medical devices.

Safety, clinical performance and/or effectiveness information that is generated from the clinical use of a medical device are considered clinical data. They can usually be found in form of published literature, reports of clinical experience, post-market reports and adverse data event.

IMDRF defines clinical evaluation as a set of ongoing activities that use scientifically sound methods for the assessment and analysis of clinical data to verify the safety, clinical performance and/or effectiveness of the medical device when used as intended by the manufacturer.

What is the process of clinical evaluation as per the IMDRF?

“The manufacturer needs to:

  1. Identify the Essential Principles that require support from relevant clinical data;
  2. Identify available clinical data relevant to the medical device and its intended use;
  3. Evaluate (appraise and analyses) clinical data in terms of its suitability and contribution to demonstrating the safety, clinical performance and/or effectiveness of the medical device in relation to its intended use.
  4. Generate clinical data needed to address remaining questions of safety, clinical performance and/or effectiveness;
  5. Bring all the clinical data together to reach conclusions about the safety, clinical performance and/or effectiveness of the medical device” (1).

Result of a clinical evaluation should be compiled in a Clinical Evaluation Report. Lack of clinical evidence may require generating additional data to address the deficiency. In this respect, clinical evaluation is an iterative process.

A clinical investigation is the scientific process to generate clinical data from human subjects.

IMDRF proposes an evaluation based on 3 key considerations to clarify the need for a clinical investigation:

  1. Consider relevant clinical Essential Principles and intended use for that device (see IMDRF/GRRP WG/N47 FINAL:2018 Essential Principles of Safety and Performance of Medical Devices and IVD Medical Device);
  2. Performing risk management/risk analysis activities will help in identifying necessary data to address the residual risk associated (ISO 14971:2007);
  3. Conduct a clinical evaluation to demonstrate if there is sufficient available data; if not, generate more data.

Filippo Chierchini


Regulatory Department

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IMDRF was conceived in 2011 by voluntary medical device regulators from all around the world, as a forum to discuss future directions in MD regulatory harmonisation.

(1) Medical Device Clinical Evaluation Working Group (10/10/2019), “Clinical Evaluation Report”, in IMDRF – International Medical Devices Regulators Forum. Consulted on 03/01/2020 from

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