SYS-019 is our post-market surveillance procedure, meeting the requirements of ISO 13485, the EU MDR, and SOR 98/282.
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Each month Alysha picks a new procedure or webinar that will be eligible for the “Alysha” 50% discount. Just type Alysha in the discount code box. September’s discounted procedures is SYS-019 Post-Market Surveillance
Contents Sold with the Post-Market Surveillance Procedure
We have updated our Post-Market Surveillance Procedure (SYS-019) to include new Canadian and EU requirements as of September 5, 2026. The procedure also includes the following templates:
New Canadian Post-Market Surveillance Requirements
Post-Market Surveillance is the process in ISO 13485:2016 quality systems receiving the most amount of focus by MDSAP auditors due to updates in the Canadian Medical Devices Regulations (SOR/2020-262) and related guidance documents:
- Canadian Medical Devices Regulation SOR/2020-262
- Incident Reporting for Medical Devices (June 23, 2021)
- Foreign Risk Notification for Medical Devices (January 2021)
- Summary Reports and Issue-Related Analyses of Safety and Effectiveness for Medical Devices (January 2021)
- Guide to New Authorities on the Amendments to Include Power to Require Assessments and Power to Require Tests and Studies (June 23, 2021)
The Canadian regulations require creating and maintaining post-market surveillance summary reports for Class II, III, and IV devices licensed for distribution in Canada.
EU Post-Market Surveillance Requirements
Post-Market Surveillance is the process in ISO 13485:2016 quality systems receiving the most amount of focus by Notified Body auditors due to updates in the European Medical Device Regulations:
The EU regulations require an additional post-market surveillance section of your technical as defined in Annex III of the new MDR. The new MDR also requires a Periodic Safety Update Report (PSUR) for Class IIa, Class IIb, and Class III devices. Companies are also expected to conduct post-market clinical follow-up studies for most devices.
The post-market surveillance (PMS) plan template (TMP-031) is integrated with risk management requirements to include the risk management requirements in ISO 14971:2019, Clause 10, for collecting production and post-production information.
Additional Resources
If you are looking for additional guidance on post-market surveillance for medical devices, there is a new guidance available for post-market surveillance: ISO/TR 20416:2020 – Medical Devices – Post-Market Surveillance for Manufacturers. Medical Device Academy also created two webinars that you might be interested in for training purposes:
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510k submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Instagram.