IMDRF Offers Three Final Clinical Guidelines

Regulatory NewsRegulatory News | 11 November 2019 |  By 

The International Medical Device Regulators Forum (IMDRF) recently released three final documents on clinical evaluations, clinical investigations and clinical evidence for medical devices, replacing earlier versions of the documents developed by the Global Harmonization Task Force (GHTF).
Clinical Evaluations
In the 30-page document on clinical evaluations, IMDRF defines a 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.”
IMDRF explains that a clinical evaluation should take place throughout the lifecycle of a device and is used to determine what data will be necessary for marketing a device and whether clinical investigations are needed.
The guideline provides an overview of the general principles of clinical evaluation for medical devices, in vitro diagnostics (IVDs) and software as a medical device (SaMD) products. It discusses a range of issues including data sources and documentation, appraising and analyzing clinical data and compiling a clinical evaluation report.
Clinical Investigations
The 11-page document on clinical investigations explains that clinical investigations for medical devices are “any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety, clinical performance and/or effectiveness of a medical device.” IMDRF notes that the document does not apply to IVDs.
The document also provides insights on when a clinical investigation is needed, the general principles for designing a clinical investigation and ethical considerations for protecting human subjects involved in clinical investigations.
According to the document, clinical investigations should be considered when data is needed to demonstrate the safety, clinical performance or benefit/risk profile of a device that cannot be gathered from other sources, including scientific literature and nonclinical testing.
Clinical Evidence
In its 8-page document on the key concepts and definitions for clinical evidence, IMDRF provides definitions for clinical investigations, clinical data, clinical evaluation and clinical evidence and discusses the relationship between those concepts.
Clinical evidence itself is defined as “clinical data and its evaluation pertaining to a medical device” and is used to support the marketing of a device. The document also explains that clinical evidence should be reviewed and updated throughout the lifecycle of a device.
IMDRF also notes that converging requirements for clinical evidence for medical devices “will lead to better understanding of medical device safety, clinical performance and/or effectiveness by all stakeholders” and more efficient use of resources.


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