Guidance on summary reports and issue-related analyses for medical devices: Summary reports

On this page

• About summary reports
• Timelines for preparing summary reports
• How devices are grouped
• Acceptable format and information to include
• Notifying Health Canada of a change in benefits or risks
• Requests for summary reports or supporting information
• Retention time for keeping summary reports

About summary reports

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:

• the preparation, retention and submission of summary reports (sections 61.4 to 61.6)
• the completion of issue-related analyses of safety and effectiveness (sections 25(1) and 39)

For summary reports, medical device licence holders must conduct a concise, critical analysis periodically from information received about the use of their licensed device(s). This information comes from reports of:

• adverse effects
• problems reported to the manufacturer, importer or distributor of the device relating to performance characteristics or safety, including any consumer complaints
• incidents that have come to the attention of the manufacturer or the importer of the device (see section 59(1) of the Regulations)
• serious risks of injury to human health that were identified outside of Canada (see section 61.2(2) of the Regulations) 

Medical device licence holders must then prepare a report that summarizes the relevant information received during the reporting period.

When preparing the summary report, the licence holder must determine if there has been a change in what’s known about the benefits and/or risks associated with the device. If the licence holder determines that there has been a change, they must notify Health Canada in writing within 72 hours. Further details on how to notify Health Canada are included below.

All of the information in a summary report forms part of ongoing post-market monitoring by medical device licence holders of Class II, III and IV medical devices. The timing, frequency and type of scanning should depend on a number of factors, such as:

• the risk profile of the device, with details of the risks and benefits
• any known or specific issues that have arisen
• the scheduling of the summary report

Identified and potential safety issues, as well as knowledge gaps (for example, related to new patterns of use or long-term use), may require more active monitoring.

Health Canada may ask for a summary report and/or the information used to prepare the report if an examination of the benefits and/or risks of the device is determined to be necessary. We may request this at any time.

This information should increase knowledge about the benefits and risks associated with the use of a device in real-world situations.

Timelines for preparing summary reports 

Summary reports must be prepared as follows:

• for medical device licence holders of Class II devices: every 2 years with information gathered during the previous 24 months
• for medical device licence holders of Class III and IV devices: every year with information gathered during the previous 12 months

The reporting period isn’t tied to the anniversary date of a medical device licence. Licence holders may choose the reporting period for the report as long as the report falls within the required reporting timeframe. With this flexibility, licence holders are able to use the same timeline for both the Canadian summary report and similar reports created to meet the requirements of international jurisdictions.

Licence holders are required to prepare summary reports for as long as their device is licensed in Canada.

How devices are grouped

A summary report is required for each medical device licence.

It may be reasonable to combine certain devices when preparing a summary report, even if they’re not included in the same licence. Combining devices from different licences can help to identify changes to what’s known about the benefits or risks of those devices. For example, how devices are used may reveal risks that are harder to find when information relevant to only one licence is assessed in isolation.

Devices can be grouped into 1 of 4 types as defined in the Regulations:

1. medical device family
2. medical device group
3. medical device group family or
4. medical device system

Note: When grouping devices in accordance with a medical device system, it is not necessary that all of the components or parts be sold under a single name.

As licence holders are the most knowledgeable about their own devices, they’re in the best position to determine how to combine devices when preparing a summary report. Licence holders are responsible for grouping in a way that’s best for identifying changes to what’s known about the benefits or risks of their device(s). A decision to group devices or combine data should not prevent issues from being identified that would have been detected without the grouping.

If a licence holder decides to combine devices that are not included under a single licence, they should provide a rationale to support their decision. Grouping devices just because they’re manufactured in the same manufacturing facility and have the same users, cautions or intended use may not be an acceptable rationale. The rationale should explain how the grouping does not prevent the ability of the licensee to analyze data or detect changes to what’s known about the benefits or risks of each device. 

Devices can also be grouped in a manner that has been specified in jurisdictions outside Canada to meet similar periodic reporting requirements. It’s possible to use the same grouping combination to meet Canada’s regulatory requirements, however, this must meet Health Canada’s summary reporting requirements.

Acceptable format and information to include

The summary report should add to the cumulative knowledge about the safety and effectiveness of a device from real-world use. The depth of analysis required for the report depends on the nature and amount of information collected. More information and greater analysis may be required for higher-risk devices.

The report should summarize and integrate new cumulative safety and effectiveness knowledge gained from experience during the reporting period. While it may be prepared as a cumulative summary from the date of first licensing or sale in Canada, conclusions should be specific to the reporting period.

Information specific to the Canadian context is an important part of the summary report. Canadian adverse effects, problems and incidents must be included in the analysis, if applicable. Including information about the use of the device outside Canada is also recommended. Such information gives a more fulsome view of the device’s risks and benefits.

Different formats are acceptable for a summary report, including those from other jurisdictions, as long as the report includes the required information outlined in sections 61.4(1) to 61.4(5) of the Regulations.

For example, the Periodic Safety Update Report format as required in the European Union may be an acceptable approach to fulfilling the summary report requirement in Canada.

Information in a summary report may vary from report to report. However, a report should contain the following sections:

• introduction or cover page
• summary of changes to the device or licence
• analysis
• conclusion

Be sure to provide an explanation if a particular section is not completed (for example, no new information).

Introduction or cover page

Identify the licence (or licences) and device (or devices) covered under the summary report and include:

• date of the report
• time period for which the report is being completed
• device licence number and details on the medical device, medical device group, medical device family and/or medical device group family
• identifier(s), if applicable
• name and address of the licence holder
• list of countries where the device(s) was/were distributed, sold or available during the reporting period

Summary of changes to the device or licence

In this section of the report, you should provide a summary of changes to the device or the authorization in Canada since the last summary report, including:

• changes made to the device or its labelling that relate to benefits or risks of the device (for example, design, intended use, contraindications)
• applications made to Health Canada for a licence amendment under section 34 of the Regulations concerning benefits or risks of the device
• recalls issued in and outside of Canada if they pertain to a serious risk of injury to human health
• changes to the information and documents supplied by the manufacturer with respect to the device, as required by section 43(1)(b) of the Regulations

You may reference information already documented in your quality management system records. However, this information should be easily retrievable in case Health Canada has further questions.

Analysis

As identified in section 61.4(3) of the Regulations, you must consider the following elements when preparing the critical analysis:  

• possible adverse effects associated with using the medical device
• problems related to performance or safety, including any complaints received by the manufacturer, importer or distributor after the device was first sold in Canada (see section 57(1)(a))
• incidents concerning a device’s failure, deterioration in effectiveness, inadequate labelling or directions for use that have led to a person’s death or serious deterioration in health, or could do so if the incident occurred again (see section 59(1))
• serious risks of injury to health that are relevant to the safety of the device (see subsection 61.2(2))
• misuse or off-label use of the medical device resulting in changes to what is known about benefits or risks associated with the device

As a licence holder, you should consider the above information in light of the number of devices sold or of estimated patient exposure to help assess the risk. For example, include Canadian sales rates if they’re available. You could also use sales rates in other countries where the device is marketed to help with your analysis. 

You should also consider whether the number of units sold reflects exposure most accurately. For example, using units sold would only be valid for single-use devices. For other devices, it may be better to consider the number of procedures performed or patient hours using the device. For example, for devices that are used multiple times, such as infusion pumps or glucose monitors, it may be more appropriate to estimate the number of uses overall or patient hours using the device. You should also consider breaking out data based on indicated use or patient population.

Data gathered for analysis should also include data collected outside of Canada if there is limited Canadian data.

If available, include the following types of evidence in the analysis:

• clinical evidence updates (any new relevant clinical data from published sources, device-related investigations or ongoing clinical studies)
• information on safety or effectiveness (including published reports)
• product- or issue-specific information
• information on similar devices, including those using similar materials and/or technology

You may include other information that would be helpful to understand the risks and benefits of a device.

Conclusion

The conclusion should provide:

• an overall assessment of the benefits and risks of your device, including a determination of whether a change to the benefits or risks has occurred during the reporting period
• any changes to the benefits or risks that were identified
• any preventive or corrective actions that have been considered or implemented or that are planned as a result of the identified change

As specified in section 61.4(4), the medical device licence holder shall determine whether there has been a change to what’s known about the benefits and risks associated with the medical device. This change could include any of the following:

• the potential benefits for patients through the use of the medical device may be less
• in respect of each of the risks:
  • the harm associated with the risk is more likely to occur or
  • if the harm associated with the risk occurs, the consequences for the health or safety of patients, users or other persons could be more serious
• a new risk has been identified

For the purposes of this guidance document, a “change” has occurred when it’s believed the device may no longer meet the applicable requirements (sections 10 to 20 of the Regulations). This belief should be based on the critical analysis that was completed as part of the summary report (section 61.4(3) of the Regulations).

Here are 3 examples of a change.

1. The regulatory requirements related to safety and effectiveness were met at the time of authorization for a Class III device that is meant to remain in the body throughout its projected useful life of 10 years. While completing a summary report, it was found that a previously recognized adverse effect related to the device is occurring more often than expected after 5 years. The device’s benefits haven’t changed. Based on this new information, there is reason to believe that section 10 of the Regulations may no longer be met. This shows that the harm associated with this risk is more likely to occur.
2. The regulatory requirements related to safety and effectiveness were met at the time of authorization for a reusable, Class II home-use device. The device is being used according to the instructions and within its projected useful life. While completing a summary report, it was found that the device’s performance is deteriorating sooner than anticipated. As a result, the safety of patients is negatively affected. Based on this new information, there is a reason to believe that section 13 of the Regulations may no longer be met. This presents a new potential risk.
3. The regulatory requirements related to safety and effectiveness were met at the time of authorization for a Class IV implant. The device is known to have many potential risks, including death, but the benefits outweighed the risks. While completing a summary report, it was found that the benefits of the device are less than expected with use in a real-world situation. Based on this new information, there is a reason to believe that section 11 of the Regulations may no longer be met. This presents a decrease in the benefits that may be obtained by patients.

Potential corrective actions concerning the identified change to benefits or risks could be considered as having been met by:

• implementing a recall
• applying for a medical device licence amendment as a result of a change described in section 34 of the Regulations

In the conclusion, you should clearly state if, while completing the summary report, you determined that there was no change to the benefits and/or risks of the device.

Notifying Health Canada of a change in benefits or risks

If you determined that there was no change to the benefits and risks of your medical device since the previous reporting period, you do not need to submit the summary report to Health Canada.

As specified in section 61.4(6) of the Regulations, the medical device licence holder must notify Health Canada in writing within 72 hours after concluding that there has been a change to what’s known about the device’s benefits and risks. 

Methods to notify Health Canada include:

• submission of an application for a medical device licence amendment under section 34 of the Regulations, such that the amendment addresses the identified change
  • for Class III to IV devices, for example, see the guidance for the interpretation of a significant change of a medical device
• notification of a recall of the impacted device(s) as outlined in sections 63 to 65 of the Regulations, such that the recall addresses the identified change
  • see the guide to recalling medical devices
• submission of the summary report

If your submission of the summary report is your way of notifying Health Canada about the identified change to the benefits and/or risks of a device, you must include in the notification:

• a cover letter indicating that the information is being sent to fulfill the summary report requirements and clearly identifying the significant change, as outlined in section 61.4(6) of the Regulations
• the most recently completed summary report

In many cases, the medical device licence holder will have identified a change to the benefits and/or risks of a device through the course of ongoing monitoring activities. As a result, the licence holder may have implemented preventive or corrective actions and notified Health Canada during the reporting period (before completing the summary report). If this is the case, the licence holder must document in the summary report that:

• any necessary preventive or corrective actions were already taken in relation to the identified change to the benefits and/or risks of the device
• Health Canada has already been notified (through a recall notification or submission of a licence amendment application, for example)

Note: Unless requested, do not submit the summary report if you have already notified Health Canada about a change you identified while completing the report. As specified above, this prior notification may have occurred through compliance with other regulatory requirements.

The notice and related documents must be submitted in either English or French.

To submit a summary report to us:

devicelicensing-homologationinstruments@hc-sc.gc.ca

For questions about which changes in risks and benefits require notification, contact the Medical Devices Directorate at:

devicelicensing-homologationinstruments@hc-sc.gc.ca

Requests for summary reports or supporting information

To determine whether a medical device still meets safety and effectiveness requirements after approval, the Minister may request one or more of the summary reports from the licence holder. The Minister may also ask for the information used to create them. The request may be made at any time. The Minister may set a date when the summary reports must be submitted to Health Canada.

Retention time for keeping summary reports

As a licence holder, you must keep for 7 years:

• copies of your summary reports and
• the information used to prepare the reports

The reports and supporting information must be maintained onsite or be easily accessible.

You should also keep data used to generate the reports for 7 years in case the statistical analyses need to be validated.

During inspections, Health Canada’s inspectors may ask to see your summary reports.