SYS-019 is our post-market surveillance procedure that meets the requirements for ISO 13485, the EU MDR, and SOR 98/282.
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, including templates for the following:
- TMP-008 A D1 Post-Market Clinical Follow-Up (PMCF) Checklist
- TMP-031 A D2 Post-Market Surveillance / Risk Management Plan Template
- TMP-032 A D1 Post-Market Surveillance (PMS) Report Checklist
- TMP-033 A D1 Periodic Safety Update Report (PSUR) Checklist
- TMP-044 A D1 Post-Market Surveillance (PMS) Summary Report Template
- TMP-045 A D1 Issue-Related Analysis of Safety and Effectiveness Template
- LST-010 A D2 PMS Review Program Log
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 new regulations require creating and maintaining post-market surveillance summary reports for Class II, III, and IV devices licensed for distribution in Canada.
New 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 new regulations require an additional post-market surveillance section of your technical as defined in Annex III of the new MDR. The are also new requirements for the creation of a Periodic Safety Update Report (PSUR) for Class IIa, Class IIb, and Class III devices. It is also an expectation for companies to conduct post-market clinical follow-up studies for most devices.
We also updated our post-market surveillance (PMS) plan template (TMP-031). The new template is now 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:
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