The new article describes in detail the approach to be applied when analyzing the data deriving from clinical investigations.
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 describes the regulatory requirements related to the processes and procedures to be undertaken to collect additional data which is necessary to assess the safety and performance of a medical device when used for its intended purpose. It is important to mention that provisions of the present guidance are non-binding, so the recommendations provided in the document could be subject to changes, should it be necessary to reflect the respective amendments to the underlying legislation.
Clinical Data Analysis: Key Points
According to the guidance, the goal of the analysis stage is to determine if the appraised data sets available for a medical device collectively demonstrate the clinical performance and safety of the medical device about its indications for use. As further explained by the HSA, clinical analysis includes the use of quantitative or qualitative methods. Due to the wide use of data deriving from literature review and historical data, the methods used are mostly qualitative. The authority also describes the concept of “pivotal” datasets that are used when assessing the safety and effectiveness of medical devices. These datasets are used to assess consistency concerning the risks associated with the use of the device, as well as the way it operates. Should the different results be obtained when assessing the datasets related to the same device, it is important to analyze such differences to identify the grounds behind them. The authority furthermore emphasizes the importance of the inclusion of any datasets into the scope of the assessment.
It is stated that in the course of clinical data analysis it should be confirmed that:
- The medical device performs as intended by the product owner;
- The medical device does not pose any undue safety concerns to either the recipient or end-user; and
- Any risks associated with the use of the medical device are acceptable when weighed against the benefits to the patient.
When assessing the aforementioned factors, it is also important to take into consideration additional aspects related to the patients involved, the way the monitoring has been performed, incidents and adverse events associated with the device in question, and the condition for treatment of which the device is intended. Apart from this, it is also important to consider alternative treatment options available.
The authority also mentions that the party responsible for a medical device should review the documentation accompanying the device, including the instructions for use, to ensure that all the important aspects are duly addressed therein.
Clinical Evaluation Report
Another important aspect addressed in the guidance is the approach to be applied to the clinical evaluation report – the one that should be prepared upon completion of the clinical evaluation process. The said report should cover the scope of the assessment, the initial data analyzed, the approaches and methods used, and also the conclusions made based on the analysis.
According to the guidance, the information provided in the clinical evaluation report should be comprehensive enough to make sure a third party could assess the document separately. In particular, the report should address such aspects as:
- The technology on which the medical device is based, the intended purpose of the medical device, and any claims made about the medical device’s clinical performance or safety;
- The nature and extent of the clinical data that has been evaluated; and
- How the referenced information (recognized standards and/or clinical data) demonstrates the clinical performance and safety of the medical device in question.
The authority also mentions that the said report should be duly signed by an authorized person responsible for the evaluation, while the appointment of such person should be duly justified.
To assist in complying with the applicable regulatory requirements for the clinical evaluation report, the authority also provides a suggested format to be followed. However, specific aspects should be considered on a case-by-case basis – for instance, the level of detail covered by the document should depend on the scope of the assessment. The authority describes the example of the situation when the party responsible for the device in question relies significantly on the clinical data related to the similar product – in such a case, it is allowed to make references to the respective evaluation related to the said device.
As further explained by the HSA, a clinical evaluation report should contain, inter alia, the following elements:
- General details (basic information about the device in question and also the parties responsible for it);
- Product description and details regarding the intended use including, inter alia, the details related to:
- Materials, including whether it incorporates a medicinal substance (already on the market or new), tissues, or blood products;
- The medical device components, including software and accessories;
- Mechanical characteristics; and
- Other, such as sterile vs. non-sterile, radioactivity, etc.
- Details about the indications for use and claims made by the manufacturer regarding the therapeutic effect caused by the product.
- Context of the evaluation and choice of clinical data types. In this section, the manufacturer shall address the aspects related to the technology the product is based on (whether it is novel or an already known one), so the scope of information the authority would expect the interested party to submit would depend on the technology and history of its use.
Apart from the matters described herein, the document also addresses certain specific aspects associated with clinical trials. In particular, it contains a flowchart that describes in detail the stages of a clinical evaluation. According to the guidance, it includes the following stages:
- Identifying clinical data deriving from literature search or clinical experience or investigation;
- Appraisal of individual data set (suitability and contribution of results to a demonstration of performance and safety);
- Analysis of relevant data (strength of overall evidence and conclusions about performance and safety).
The process described hereinabove should be repeated until it will be determined that the clinical evidence available is sufficient to demonstrate compliance with the respective Essential Principles of Safety and Performance of Medical Devices.
In summary, the present HSA guidance outlines the most important aspects associated with the clinical evaluation of medical devices. The document highlights the matters requiring the most attention to ensure compliance with the applicable regulatory requirements.
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