The International Medical Device Regulators Forum (IMDRF) has released three final guidelines relating to clinical evaluations, clinical investigations and clinical evidence for medical devices.
These documents supersede earlier versions produced by the Global Harmonisation Task Force (GHTF), and their primary purpose is to provide manufacturers with guidance on how to demonstrate compliance with the relevant principles for medical devices.
The document on clinical evaluations explains that they should take place throughout the lifecycle of a device and can be used to determine what data is required for marketing a device, and therefore, if a clinical investigation is needed. It also provides a summary of the principles of a clinical evaluation for medical devices, in-vitro diagnostics (IVDs) and software medical devices (SaMD).
The clinical investigations guidance outlines when a clinical investigation is needed, the general criteria for designing one and the ethical considerations for protecting human subjects involved. Clinical investigations should be considered when data cannot be obtained from scientific literature and non-clinical testing to demonstrate safety, performance and “benefit v risk” profile of a device. This document does not apply to IVDs.
Finally, the clinical evidence guidance discusses the relationship between the concepts of clinical investigations, data, evaluations and evidence. The document explains that clinical evidence should be reviewed and updated throughout the device lifecycle. The IMDRF also claims that converging criteria for clinical evidence for medical devices can lead to improved understanding of safety, performance and effectiveness for all stakeholders involved, through more efficient use of resources.
The three final guidelines can be accessed here.