The article provides an overview of the trend report template issued by the Swiss regulating authority.
Table of content
Swissmedic, the Swiss regulating authority in the sphere of healthcare products, has published a template to be used by medical device manufacturers when reporting trends they have identified with respect to the products they are responsible for.
The template covers the key points to be included in such a report to ensure it contains comprehensive information necessary to ensure continued safety and proper performance of medical devices.
The present document titled “Manufacturer’s Trend Report” or “TrendR” is intended to be used by the parties responsible for medical devices when reporting trends associated thereto.
Therefore, the primary objective of the template is to be used when reporting trends, potentially those observed when the devices are available for marketing and use.
The report constitutes an updated version of the one issued previously by Swissmedic and replaced by the current revision.
The association of this report with the “Medical Devices Vigilance System” further emphasizes its role in ensuring the safety, effectiveness, and quality of medical devices.
Instructions for Initial Application
Submitting an initial application requires precision and completeness. Every field in the template demands attention, suggesting the importance of each piece of information in constructing a comprehensive trend report.
However, it is also important to mention that some of the rules have exemptions to be taken into consideration when completing the report.
In this context, the “4.2 analysis update” stands out as a section that doesn’t require completion for initial applications.
The specificity of this instruction indicates the systematic nature of the reporting process, where certain data or analysis might only become relevant or available in subsequent stages or under specific circumstances.
It is also important to mention that the submission of a report using the present template is merely a submission of observed data and trends; it doesn’t inherently carry with it any conclusions. Three primary clarifications are emphasized:
- Content Completeness and Accuracy: The submission of the report itself doesn’t confirm the absolute completeness or accuracy of its content – it is merely an acknowledgment that, while every effort may have been made to ensure the data’s accuracy.
- Device Performance Implications: A critical point of understanding is that any mention of a medical device within this report doesn’t automatically label it as “failed” or “faulty”.
The report may contain observations, but it doesn’t pass judgment. It refrains from making conclusions based merely on initial observations or unverified data.
- Health Impacts: The report doesn’t assert that any medical device was the direct cause or contributor to an alleged health deterioration of any form.
In particular, the authority follows the principle stating that correlation doesn’t imply causation.
According to the template, the trend report should contain such details as:
- Information about the submitter (responsible party, including the medical device manufacturer and its authorized representative, where applicable);
- Information about the medical device in question, including the Unique Design Identification, categorization of the device, its description, and also the indication of the applicable risk-based classification together with the details on the markets where the device is available and on the accessories used;
- Information about the trend identified, including potential risks and hazards, as well as the details on the estimated number of devices placed on the market;
- Initial analysis conducted by the manufacturer (both preliminary comments and final investigation results).
The authority additionally emphasizes the importance of ensuring compliance with the required form of the report. In particular, it should be compiled and sent either as a Word document or a PDF file.
In summary, the present trend report template issued by Swissmedic outlines the key points to be covered by a trend report medical device manufacturers should submit with respect to the products they are responsible for.
The document describes the expected content of the report and highlights some of the key aspects to be taken into consideration when completing and submitting the respective report.
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