Health Canada has issued guidance on summary reports to implement a lifecycle approach to the regulation of medical devices in Canada.

Health Canada has issued a guidance on Summary reports and issue-related analyses for medical devices to help medical device manufacturers comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices Regulation. Two new requirements have been added to the regulation to help identify changes to what’s known about the benefit/risk ratio of medical devices on the market in Canada.

A summary report is a comprehensive assessment of new information on the benefits and risks of a licensed Class II, III or IV medical device. The guidance document clarifies Health Canada’s expectations on the preparation of summary reports.

A summary report is required for each medical device separately and is to be submitted by the license holder, usually the manufacturer. Health Canada may also ask manufacturers of a Class I, II, III or IV medical device to prepare and submit an issue-related analysis if deemed appropriate.

The time frame for the reporting requirements is:
Class I devices: No requirement for Summary reports
Class II devices: Every 2 years with information for previous 24 months,
Class III and IV devices: Yearly with the information for previous 12 months.

The reporting period is not tied to the anniversary date of a medical device license. License holders may choose the reporting period for the report if the report falls within the required reporting timeframe. This means that the above reporting requirement can be combined with the creation of the PSUR for EU.

Note that the retention time for summary reports including the underlying statistical data is at a minimum 7 years.

The additions to the regulation will come into force 23 Dec 2021 so it is important to have procedures in place even if the reporting is not due until 24 months. Auditors will ask about your preparedness for the new requirements.

Link to guidance: Guidance on summary reports and issue-related analyses for medical devices.

Hello,
this year’s Midsummer weekend, and the start for Sweden’s summer holiday season is just a few days away.

For many of us, both working and everyday life became completely different, starting from March 2020. QAdvis has since then conducted its operations almost entirely on a remote basis. Different solutions made it possible to follow through within our projects, courses and seminars and to continue to offer our services without interruption.

We don’t know what the new “normal” is going to look like. What we do know, however, is that we will continue to carry out our services, we are still offering open and client specific courses as well as free seminars.

If you have missed out on any of our free seminars, you also have the opportunity to see them afterwards here: Previous presentations …

Do you have questions or want to know more about us and our services, please contact us at info@qadvis.com, or follow us on LinkedIn and if you have questions or concerns regarding our course and seminars, you can always reach us at academy@qadvis.com.

My colleagues and I hope that you have a really nice summer, and as the community is slowly reopening we look forward to welcome you personally at our premises in Lund or Kista.

 

Kindly Regards
Hermine Redl, Office Manager at QAdvis