Canada: Summary Reports and Issue Related Analysis

Good day everyone, here at MedTech Compliance Chronicles, we have been exploring how Canada regulates medical devices for quite some time. We have brought our devices to market and learned that regulatory obligations do not stop there. Post-market surveillance (PMS) is a paramount responsibility of any medical device manufacturer. After covering the more reactive side of PMS, incident reporting, in our previous post, we now turn to two additional tools that help Health Canada and manufacturers monitor device trends more proactively: summary reports and issue-related analyses.

These reports allow manufacturers to identify early signals of potential risk, summarize global experience with their devices, and provide Health Canada with focused evaluations when specific concerns arise. In the following sections, we will look at what each type of report entails, the regulatory expectations under the Canadian Medical Devices Regulations (CMDR), and how they fit into a well-structured quality management system.

Summary Reports

Summary Reports are a mandatory, proactive post-market surveillance tool required by Health Canada, specifically Sections 61.4 through 61.6 of the CMDR. These reports are a component of the total lifecycle approach to medical device regulation, ensuring that the safety and effectiveness profile established during the licensing process remains valid throughout the device's time on the Canadian market. They apply to all Class II, III, and IV licensed medical devices; Class I devices are exempt from this requirement. For the license holder, the core purpose of preparing this report is to conduct a concise critical analysis of all relevant post-market information collected during the reporting period, culminating in a determination of whether or not the known benefits and risks associated with the device have changed.

For Class II devices, summary reports must be completed every two years (biennially). For Class III and IV devices, reports must be prepared annually. License holders must produce these reports as long as the device is authorized for sale in Canada, regardless of actual sales volumes during the period. Each report must summarize all known information about the device’s performance, safety, and adverse events gathered from both Canadian and international sources during the reporting period. This includes the number and nature of complaints received, any incidents or near-incidents, device malfunctions, or observed changes in device performance. Manufacturers must also document any corrective or preventive actions implemented, updates to labeling or instructions for use, and relevant findings from trend analyses. Even if no new complaints or incidents have occurred, the manufacturer must still prepare the report and state that no new information has been identified.

The format of a summary report typically includes a cover page, summary of changes to the device or license, analysis of received information, and a conclusion on whether any new risks or benefits have been identified. If the conclusion drawn is that there is a change to the benefit-risk profile of the device, Health Canada must be notified of this conclusion and provided with a copy of the summary report within 72 hours. Otherwise, summary reports do not need to be submitted to Health Canada, but must be kept on file, along with all of the information and data used to generate them, for a period of seven years after their creation. Health Canada reserves the right to request summary reports or any of the information used in their preparation at any time.

Issue Related Analysis

An issue related analysis (IRA) for medical devices in Canada is a targeted, ad hoc report that medical device manufacturers and license holders must prepare upon request from Health Canada when there is reasonable concern that a device may not meet safety or effectiveness requirements (sections 10-20 of the CMDR). Unlike routine summary reports, IRA’s are not scheduled at regular intervals but are triggered by specific safety or performance issues identified post-market. Health Canada’s authority to require such analysis is established under sections 25 and 39 of the CMDR, and applies to all medical device classes, including Class I.

An IRA is generally more detailed than a summary report, but focused only on the specific issue stated in the request from Health Canada. It should include the manufacturer’s investigation plan, data sources reviewed, and a clear assessment of the issue’s root cause or contributing factors. The analysis must evaluate the potential risk to patients and users, describe any corrective or preventive actions implemented, and compare the frequency or severity of the problem across markets. Health Canada may also request that the manufacturer assess whether the issue affects other related models or product lines.

The content of an issue related analysis should include sections related to incidents and complaints related to the issue, exposure and / or sales data, malfunction trends / quality issues, impacted labeling, all supporting evidence and data and a conclusion.. After preparation, the completed analysis must be submitted directly to Health Canada within the timeline they stated in their request (Health Canada is generally quite strict about timelines for IRA’s) for the IRA and retained for a period of seven years. Health Canada reviews the analysis to determine whether the manufacturer’s conclusions and actions are adequate, or whether further regulatory steps, such as additional monitoring, recalls, or safety communications, are warranted.

Conclusion

The Canadian regulatory framework employs a comprehensive, lifecycle-based approach to medical device surveillance. Summary reports provide a structured, periodic evaluation of the ongoing safety and effectiveness of higher risk devices, enabling manufacturers to systematically assess new information and report significant changes to Health Canada. On the other hand, issue related analyses are targeted, ad hoc reports prepared in response to specific safety or performance concerns raised by the regulator, ensuring swift and detailed examination of emerging risks. Together, these requirements ensure that the benefit-risk profile of authorized devices is continually scrutinized against real-world data.