The new article addresses the aspects related to the sources of data used in the context of clinical evaluation of medical devices.
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The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has published a draft guidance document dedicated to clinical evaluation of medical devices.
Once finalised, the guidance will provide an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance thereto.
At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations.
The authority also reserves the right to make changes to the guidance and recommendations provided therein, should such changes be necessary to reflect corresponding amendments to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to the sources of data to be used in the context of clinical evaluation of medical devices.
Data Sources: Key Points
Clinical evaluations of medical devices are dependent on a variety of data sources. These sources can either be owned directly by the product developer or by third parties, or they might be accessible through scientific literature.
By the applicable regulatory requirements, the responsibility of identifying the necessary data and determining the required types and amounts for a thorough clinical evaluation lies with the product owner.
Literature Searching as a Data Source
As explained by the HSA, literature searches play a pivotal role in identifying published clinical data that is beyond the product owner’s immediate possession.
This data is critical in establishing the safety and performance of the medical device.
It encompasses a range of information including reports from clinical investigations, adverse event reports, and data on comparable medical devices.
In many cases, literature-derived data constitutes a major portion of the clinical evidence, thereby making extensive and rigorous literature reviews vitally important.
The value of published data in determining the device’s performance and safety is carefully considered, especially in light of the study’s design and analytical quality.
Methodology for Literature Searching
The methodology employed for literature searching is based on well-formulated review questions and a detailed protocol.
This protocol aims to identify, select, and compile relevant publications. Such a task requires sufficient expertise in information retrieval and alignment with the overall scope of the clinical evaluation.
The protocol must specify the data sources, the extent of database searches, criteria for literature selection, and methods to manage data duplication.
A comprehensive report is then compiled after the search, incorporating the original protocol and highlighting any deviations from it.
Clinical Experience Data
Clinical experience data includes information gathered from the actual use of the medical device in real-world settings outside formal clinical investigations.
This data category encompasses sources like post-market surveillance reports, registries, adverse event databases, and various forms of real-world data such as medical records and feedback from wearable technologies.
Such data is vitally important in understanding the device’s performance in diverse, real-world environments.
It is particularly crucial for identifying rare but serious adverse events and for providing long-term safety and performance data.
This type of data is especially significant for devices that are low-risk and based on well-established technologies.
Use of Clinical Experience Data
The authority additionally emphasizes that in using clinical experience data, it is vitally important to ensure that reports and data compilations offer enough detail for an objective assessment of the device’s performance and safety.
Inadequate sources of information, such as unsupported opinions, are deemed unsuitable. Post-market surveillance reports are a vital component, as they include details such as the device’s regulatory status, actions undertaken during the reporting period, and a detailed record of adverse events.
These reports offer substantial insights into the clinical safety and performance of the medical device.
Data from Clinical Investigations
Data from clinical investigations, which are carried out for conformity assessment by applicable regulations, are an essential component of clinical evaluations.
These investigations are expected to be in line with such applicable standards as ISO 14155 or equivalent, ensuring compliance with the relevant local regulations.
The documentation from these investigations is extensive, including the clinical investigation plan, any amendments to it, relevant ethics committee documentation, case report forms, regulatory approvals, conflict of interest disclosures, and the final report of the investigation.
The clinical investigation plan is important, as it contains comprehensive information about the study design, such as participant selection and treatment methods, which are key factors in evaluating the significance of the results.
Ethical Considerations and Role of Registries
The evaluation process also necessitates an assessment of the ethical compliance of the investigation, ensuring alignment with standards including the Declaration of Helsinki and local regulations.
Non-compliant investigations are typically rejected. Furthermore, registries are recognized as a useful tool in supporting regulatory decision-making, though their data quality and robustness require careful evaluation.
Guidelines for using data from registries for regulatory purposes are outlined in IMDRF’s technical documents.
Conclusion
In summary, the guidance describes in detail the approach to be followed when gathering and analyzing data for the clinical evaluation of medical devices, highlighting the significance of each type of data source in ensuring the device’s safety and efficacy.
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