Post-Market Surveillance International: USA and Canada

Post-Market Surveillance (PMS) has become more or less routine for manufacturers of medical devices placed on the EU market since May 2021. The requirements for the PMS system under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) have increased compared to the Medical Devices Directive 93/42/EWG (MDD) and the In Vitro Diagnostic Medical Devices Directive 98/79/EG (IVDD) and there is more intense scrutiny by Notified Bodies on how information is collected from the market, analyzed, and evaluated.

While many manufacturers have been focusing on the European PMS requirements lately, it is necessary to stay informed about global PMS requirements. In this article, we want to sharpen our focus on international requirements, specifically the situation of PMS in Canada and the United States, to show how they differ from those of the MDR and IVDR.

A look across the pond

Continuous reporting requirements: Canada versus the EU

Both Canada and the EU have recently increased their Post-Market Surveillance (PMS) requirements and now mandate periodic reports summarizing PMS data, analyses, and conclusions. However, while the EU stipulates a Periodic Safety Update Report (PSUR) or PMS report (depending on the risk class) for all medical devices covered under the MDR or IVDR and for all "legacy devices", Canada only requires a "summary report" for medical devices that require a Canadian medical device licence, i.e. for Class II, II, and IV devices.

Both the European Union and Canada mandate the preparation of comprehensive reports evaluating the impact of new information on the benefits and risks of medical devices and in vitro diagnostics (IVDs). Such information may include a change in the risk profile, for instance, arising from new or emerging risks, or a stated benefit that has not been achieved. Both the EU and Canada provide useful guidance to assist in the preparation of these reports, namely the MDCG 2022-21 and the "Guidance on summary reports and issue-related analyses for medical devices", respectively.

It is important to note that Canada has not tied the reporting period to the anniversary of the medical device licence. Consequently, it is possible to align the Canadian "summary report" with the preparation of the PSUR, for example. This alignment reduces the amount of work needed to produce the reports since there is a natural overlap in the PMS datasets examined for each report.

Of course, this alignment may be difficult if the reporting periods for the risk classes are different between the EU and Canada. The maximum duration of the reporting period in Canada is two years for Class II medical devices and one year for Class III and IV medical devices. In the EU, the PSUR should be updated every two years (or as required) for Class IIa devices and at least annually for Class IIb and III medical devices and IVDs in risk classes C and D.

The "522 order" as the key to reporting obligations in the USA

For the US market, the counterpart to the post-market surveillance requirements of the MDR can be found in "21 CFR 822", which implements Section 522 of the "Federal Food, Drug, and Cosmetic Act" (FD&C Act). This guidance (Postmarket Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act) assists medical device manufacturers who are subject to the Section 522 Post-Market Surveillance Order "522 orders" by providing an:

• overview of Section 522 of the FD&C Act,
• information on how to fulfill the requirements,
• recommendations for the format and content of the PMS plan and report, and
• updated categories of the monitoring status.

The biggest difference to the European requirements for the PMS system is that the preparation of PMS reports or PSUR does not have to be carried out continuously for all medical devices in the United States. Only Class II and III devices are subject to these requirements, and only when the manufacturer receives a 522 order from the Food and Drug Administration (FDA). The reasons for a 522 order are as follows:

• Failure of the product would be reasonably likely to have serious adverse health consequences.
• It is expected to have significant use in pediatric populations.
• It is intended to be implanted in the body for more than one year.
• It is intended to be a life-sustaining or life-supporting device used outside a device user facility.

The 522 order provides the reason for Post-Market Surveillance and offers general or specific guidance to aid the manufacturer in developing an appropriate PMS plan. Moreover, the 522 order may include a timeline for achieving milestones and submitting reports. It should be noted that the PMS plan must be submitted to the FDA within 30 calendar days of receiving the 522 order.

The requirements of the FDA also differ from those of the MDR and IVDR regarding the preparation of reports. According to the MDR and IVDR, typically one report is required per plan and the plan is updated once per cycle. However, you can also write one PMS plan that is valid for multiple cycles until an update is required. Conversely, the FDA mandates interim reports along with a final report. The interim reports are categorized as either "Postmarket Surveillance Status Reports" or "Enrollment Reports". The former must be submitted twice a year during the first two years and yearly thereafter while the submission of enrollment reports is based on the milestones outlined in the PMS plan.

Conclusion

Global PMS is a topic that is likely to grow in global importance.

There is a growing trend towards country-specific regulations that must each be carefully implemented. However, despite the different requirements, all regulations share a common goal: ensuring the safety and performance of medical devices and in vitro diagnostics (IVDs) in the field throughout their product lifecycle. A strategic, coordinated approach to fulfilling international PMS requirements is the right way to maximize benefits, add value, and reduce complexity.

We hope that this summary will assist you on your international journey, particularly as the first reports are already required both in Canada and the EU! We would be happy to support you in all areas of Post-Market Surveillance (PMS), according to your specific needs and requirements.

Best Regards
Björn-Carsten Schüre and Dr. Jennifer Dean

Björn-Carsten Schüre	Dr. Jennifer Dean
IVD and PMS Expert Regulatory Affairs & Technical Documentation	Medical Device Expert Regulatory Affairs & Technical Documentation
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