The new article highlights the aspects related to the general principles of clinical evaluation.
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The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to clinical evaluation of medical devices.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration in order to ensure compliance thereto.
The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The document describes, inter alia, the general principles of clinical evaluation, including the scope of the evaluation, and the way it should be performed, and also addresses specific aspects related to the evaluation of in vitro diagnostic medical devices (IVDs) and software.
General Principles of Clinical Evaluation: Overview
The clinical evaluation of a medical device is a critical and methodical process intended to ensure the safety and efficacy of a medical device throughout its entire lifecycle.
This involves a detailed analysis of pre-market and post-market clinical data related to the intended use of the device.
This data covers not only the specific clinical performance and safety information of the medical device but also considers any data from other devices that the manufacturer claims to be comparable.
The general goal is to establish a robust evidence base that supports the clinical claims made by the manufacturer with respect to the device, its safety, and effectiveness, ensuring that all labelling and informational materials provided with the device, including contraindications, precautions, and warnings, are accurate and sufficient. The Instructions for Use must also be appropriate and user-friendly.
Clinical Evaluation Scope
According to the guidance, the scope of the clinical evaluation is vitally important and must be clearly defined from the very beginning.
It should be aligned with the Essential Principles that are applicable from a clinical standpoint. This includes a careful examination of whether the device has any design features or is intended for target populations that necessitate specific attention.
For example, the clinical evaluation should scrutinize any special performance or safety concerns presented by design features, such as the inclusion of medicinal, human, or animal components.
The evaluation should also consider the intended purpose and application of the device, encompassing the target treatment group, disease conditions, proposed contraindications, and the method of application.
Moreover, the specific claims about the device’s performance and safety made by the manufacturer must be critically assessed.
The evaluation scope should be described in the manufacturer’s risk management documentation, which should outline the identified risks associated with the device and the strategies implemented to mitigate them.
The clinical evaluation addresses the significance of any residual risks post-mitigation.
Comparable Devices and Clinical Evaluation
As further explained by the HSA, in evaluating a medical device, it is permissible to use data from comparable devices to support claims of safety and performance.
However, this is conditional on the comparable devices having similar intended purposes, technical characteristics, and biological properties.
These similarities must be carefully weighed against any differences that could potentially affect the safety and performance of the device under evaluation.
Sometimes, the devices may be so similar that there is no clinically meaningful difference in safety and performance outcomes.
Despite this, relying solely on data from comparable devices might not suffice for compliance with the Essential Principles, and additional clinical evidence might be necessary to fill any gaps.
Data Sources and Data Types for Clinical Evaluation
The selection of data sources and types for clinical evaluation is a complex process that must take into account the device’s design, its intended purpose, and the associated risks.
The nature of the technology upon which the device is based – whether it is a new or established technology – also plays a significant role.
For devices that leverage established technologies intended for a known clinical application, the clinical evaluation may primarily rely on recognised standards, literature reviews, and clinical experience with comparable devices.
In contrast, high-risk devices, those based on new or less familiar technologies, or those that extend an existing technology’s intended purpose, will likely necessitate data from clinical investigations.
Product owners must carefully weigh the benefits and limitations of each type of data in the context of their specific device.
Clinical Evaluation: Process
Performing a clinical evaluation is a structured process that includes three discrete stages, namely:
- The identification of relevant standards and clinical data sets that are related to the evaluation.
- The appraisal of each data set, considering its relevance, applicability, quality, and clinical importance.
- The analysis of these data sets, resulting in conclusions about the device’s clinical performance, safety, and adequacy of its presentation, including labeling and patient information.
A comprehensive clinical evaluation report should be compiled at the end of this process, forming a part of the clinical evidence for the device. Should the evidence be found lacking, the manufacturer is obliged to collect additional data to remedy the deficiencies, highlighting the iterative nature of clinical evaluations.
Qualifications of Clinical Evaluators
The document also covers the aspects related to the qualification of persons conducting a clinical evaluation.
According to the guidance, the clinical evaluation should be performed by individuals with appropriate qualifications and experience.
Manufacturers should justify their choice of evaluators by referencing their educational background and documented experience in related fields.
Evaluators should have expertise in the technology of the device, its clinical application, research methodology, and the conditions the device aims to treat or diagnose.
Special Considerations for In Vitro Diagnostic Medical Devices
In accordance with the applicable regulatory requirements, IVD medical devices are subject to the same stringent clinical evaluation process to demonstrate their compliance with the Essential Principles.
This includes conducting clinical performance studies that abide by high-quality study practices. The evaluation must consider the standards of the laboratories where these studies are conducted and the suitability of the study design, particularly in relation to the IVD’s risk level.
Clinical Evaluation of Standalone Software (SaMD)
Standalone Software as a Medical Device (SaMD) refers to software systems that process data for medical purposes.
Clinical evaluation of SaMDs must follow the guidelines outlined for other medical devices, with an additional focus on establishing a valid clinical association between the software’s outputs and the intended clinical condition.
This evaluation is continuous, adapting to new data and experiences as the software is used in real-world clinical environments.
Regular monitoring post-market ensures that any emerging risks are identified and managed effectively.
Regulatory guidelines for SaMD emphasize a lifecycle approach to clinical evaluation, ensuring that safety and performance are maintained throughout the software’s operational life.
These guidelines are vitally important for product owners to comply with, ensuring the SaMDs meet the necessary regulatory standards for clinical use.
Conclusion
In summary, the present HSA guidance provides a detailed overview of the general principles to be followed when initiating and conducting a clinical investigation.
The document highlights the key points to be taken into consideration by medical device manufacturers with respect to the specific aspects of the evaluation process.
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