Guidance on summary reports and issue-related analyses for medical devices: Issue-related analyses of safety and effectiveness

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Overview

This guidance document was prepared to help medical device manufacturers understand and comply with the Medical Devices Regulations. Two new requirements in the Regulations were added to ensure the continued monitoring of risks after a product is authorized for sale in Canada. The 2 requirements concern:

With respect to issue-related analyses, Health Canada may request an analysis from a manufacturer of a Class I medical device or a licence holder of a Class II to IV medical device on a safety or effectiveness issue. This is outlined in sections 25 and 39 of the Regulations. We may make the request at any time. Along with other available information, we will use these analyses when assessing the safety and effectiveness of a device authorized for sale in Canada.

Health Canada conducts a post-market benefit/risk assessment when there’s a reasonable belief that the benefits and/or risks of a medical device may have changed. We may identify a new or increased risk and/or a potential decrease in benefits concerning the use of a medical device by monitoring various sources of information, including:

For Class I devices, the manufacturer is responsible for completing the analysis and submitting it to Health Canada.

For Class II to IV devices, the medical device licence holder is responsible for completing the analysis and submitting it to Health Canada.

Types of information to include in an issue-related safety and effectiveness analysis

An analysis should be concise and fulfill the requirements set out in the request issued by Health Canada.

Information in an issue-related safety and effectiveness analysis should contain the following sections:

Device complaints and incident reports

The manufacturer of a Class I device or the medical device licence holder of a Class II to IV medical device should consider information that relates to the specified issue, including:

Information specific to Canada is recommended. Conditions of use in Canada may differ from other countries due to differences in authorized indications or practice patterns. Conversely, Canadian-specific information can sometimes be limited for some devices. As a result, information about the use of the device outside Canada should be used when available and relevant.

Depending on the nature of the issue and the information considered necessary to inform decision-making, the Minister may also specify:

Clinical data and other evidence

Include any clinical data and other evidence updates that relate to the specified issue, such as:

Exposure data or sales data

Data related to the exposure of the medical device should be included, when relevant and available. Depending on the type of device, “exposure” data may vary. For single-use devices, using the number of units sold would be valid. For devices that are used multiple times, such as infusion pumps or glucose monitors, it would be more appropriate to estimate the number of procedures/uses, health care facilities impacted or patient hours using the device, for example.

When possible, exposure data can help to put into context the number of incidents reported (for example, reporting rates). A rationale should be provided if it’s not possible to calculate reporting rates.

Device malfunction trends, quality issues and results from other analyses

Include any information relating to device malfunction and quality issues. Examples may include root cause analysis, failure modes and effects analysis, and fault tree analysis.

Labelling

As part of the analysis related to the specified issue, you should consider whether the current labelling includes the information needed to use the device safely and effectively. Information related to any potential risks should also be assessed.

Regulatory requirements related to labelling are set out in sections 21 to 23 of the Regulations, with additional information provided in our guidance documents on:

Briefly, depending on the product, labelling may include:

Conclusion

It’s important to present your conclusions about the identified issue. You may consider how the issue affects the overall safety and effectiveness of the device and whether mitigation strategies are needed to address any risk.

If you conclude that mitigation strategies are necessary, you should outline the strategies that you have taken or intend to take. You should also consider:

Timeframe for submitting an analysis

The request for analysis will specify the timeframe in which the analysis should be submitted to the Minister. The default timeframe for submitting an analysis is 30 calendar days from the date of the request. However, the Minister may ask for the report in less than 30 calendar days if the information is needed to determine if the medical device poses a serious and imminent risk to human health.

You should provide the analysis to Health Canada in electronic-only format, in either English or French. Please send your analysis by email to devicelicensing-homologationinstruments@hc-sc.gc.ca with a cover letter. In your letter, include the licence number and the reason for the submission (for example, response to sections 25 or 39).

Compliance and enforcement

If Health Canada identifies instances of non-compliance, we may then take compliance and enforcement measures following the risk-based approach outlined in the compliance and enforcement policy for health products (POL-0001). If non-compliance isn’t resolved, we may apply the provisions of the Food and Drugs Act and its associated regulations (outlined in the policy). 

Should a manufacturer of a Class II to IV device fail to comply with a request for analysis, the Minister may suspend the licence.

Should a manufacturer of a Class I device fail to comply with a request for analysis, the Minister may direct the manufacturer to stop the sale of the medical device.

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