The new article describes in detail the general principles to be followed concerning the clinical evaluation of medical devices.
The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the clinical evaluation of medical devices. The document is intended to provide additional clarifications regarding the existing regulatory framework, as well as recommendations to be considered to ensure compliance thereto. At the same time, the document does not introduce new rules or requirements itself, as is non-binding in its legal nature. The authority also reserves the right to make changes to the document from time to time, should it be reasonably necessary to reflect the respective changes to the underlying legislation. The scope of the guidance covers, inter alia, the general principles to be considered by a party responsible for clinical evaluation when planning and conducting a study. These principles are intended to ensure the accuracy and reliability of the results, as well as the safety of study participants.
Scope of Clinical Evaluation
First of all, the guidance addresses the matters related to the scope of a clinical evaluation. According to the document, when planning a study, a party responsible for it should conduct a rigorous analysis of all the data available about the medical device subject to review, including both pre-and post-market clinical data related to the safety and effectiveness of the product. The authority also mentions that the scope of such an analysis should cover not only the data related to the device itself but also the relevant data related to medical devices that are considered comparable. It is also stated that the scope of evaluation should cover all the claims made by the medical device manufacturer regarding the products and their features, including the ones indicated in the labeling and documentation accompanying the device (e.g., the Instructions for Use).
According to the guidance, before a clinical evaluation is undertaken the product owner should define its scope, based on the Essential Principles that need to be addressed from a clinical perspective. The matters to be considered by a party responsible for a medical device should include, inter alia, the following ones:
- Whether there are any design features of the medical device or target treatment populations that require specific attention. The authority further clarifies that the matters to be addressed during evaluation should include all the aspects giving rise to special concerns related to the safety and/or effectiveness of the device in question, as well as the ones related to the intended use of the product in question and the claims made by the medical device manufacturer. It is also important to mention that risk management documents of the medical device manufacturer should be also considered when deciding on the scope of a study since they contain information about the specific risks associated with the use of the product in question, and also the steps are already taken to address them. According to the guidance, the scope of a clinical evaluation should address all substantial risks associated with the device subject to review.
- Weather data from comparable medical devices can be used to support the safety and/or performance of the medical device in question. To be deemed comparable, medical devices should have the same intended purposes, while the scope of comparison should address the same aspects and characteristics. The authority additionally emphasizes that these characteristics should be similar to such an extent that there would be no clinically significant difference in the performance and safety of the medical device. When deciding on the comparability of the medical devices, a responsible party should make its decision based on the indications for use, such as disease or conditions, the intended use environment, patient population, or the technical and biological characteristics. The authority expects a responsible party to submit all the substantial information already available regarding the device.
- The data source(s) and type(s) of data to be used in the clinical evaluation. According to the guidance, the aspects to be considered when deciding on the type of data related to the clinical evaluation should include the ones related to the design, the intended purpose of the device, as well as the risks associated thereto. Apart from this, the aspects related to the technologies used should be considered as well. For instance, if the device in question employs widely used and well-known technologies, the justification would be based mostly on the applicable standards and the data collected about similar (comparable) medical devices. At the same time, for high-risk products or the ones based on the new technologies, clinical investigation data would be required. The authority states that the party responsible for the device should evaluate rigorously all the advantages and limitations associated with the specific types of data.
Performing a Clinical Evaluation
The authority further describes the particular way clinical evaluation should be performed. According to the guidance, it should include three main steps, namely:
- Identification of pertinent standards and clinical data;
- Appraisal of each data set, in terms of its relevance, applicability, quality, and clinical significance; and
- Analysis of the individual data sets, whereby conclusions are reached about the performance, safety, and presentational aspects (labeling, patient information, and Instructions for Use) of the medical device.
Once the clinical evaluation is completed, a responsible party should prepare the appropriate report based on the clinical data collected in the course of a study. Should it be identified that the data collected is insufficient to demonstrate compliance with the applicable Essential Principles, additional data should be collected to cover the gaps.
The document also outlines the scope of persons to be allowed to conduct a clinical evaluation. As explained by the HSA, they should have the experience and qualifications necessary to assess the product in question. According to the guidance, the persons conducting the study should have deep knowledge of:
- The medical device technology and its application;
- Research methodology (clinical investigation design and biostatistics); and
- Diagnosis and management of the conditions intended to be treated or diagnosed by the medical device.
Aspects Related to IVD Products
The guidance also describes the approach to be applied to in vitro diagnostic medical devices. According to the document, these products are covered by the scope of the Essential Principles in the same way as any other medical device. At the same time, certain aspects related to the IVD products are addressed separately in the device-specific guidance documents.
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