Manufacturers need to meet the country-specific PMS requirements with for instance the PSUR in Europe per (EU) 2017/745 Article 86, the Summary Reports in Canada per Medical Devices Regulations Articles 61.4 to 61.6, Post-approval Reports in US per 21 CFR part 814.84, etc. As such, PMS activities need to be planned, implemented, documented in a report, submitted to the authorities when applicable. In addition, any findings need to be considered regarding device benefit / risk profile and necessary corrective or preventive actions.

Considering the European requirements specifically, the type of PMS documents to be issued, depend on the device classification. Whereas a PMS plan is always required, a PMS report is needed for class I, Is/m/r devices and a PSUR for class IIa, IIb and III devices. The documents have to be issued per a planning also defined based on the device classification: every year for class III and IIb devices, every two years for class IIa devices and at a justified frequency for class I devices. In addition, for class III and implantable devices, PSURs need to be submitted to the notified body via EUDAMED. 

Overall, the important PMS considerations to have in mind, are:

• • Grouping of devices and rationale
• • Justification of the overall data collection period and analysis/submission (as applicable) timelines
• • Planning of PMS activities (i.e., PMS plan, PMCF plan, PMCF Evaluation Report and PSUR/PMS report)
• • Strict respect of deadlines for collection period/submission of report(s) to authorities (when applicable)
• • Specific formatting of data (e.g., per a recommended template, based on IMDRF codes in EU)
• • Contiguity of reports between updates to avoid missing any data
• • Connection with other processes (e.g., CAPA, risk management, clinical evaluation)
• • End of the PMS activities considering the device lifetime
• • How merging the PMS requirements of countries to avoid the duplication of reports

In addition, manufacturers should not underestimate the importance of Post-Market Clinical Follow-up (PMCF) activities that are required for all classes of devices in Europe. PMCF activities are intended to update the clinical evaluation report but are also the proactive part of the PMS activities. To fulfill these two objectives, PMCF activities are composed of two elements:

• • The general methods and procedures are always required to collect, for instance, literature articles, vigilance and recalls on the subject, equivalent and similar devices as reported in the databases
• • The specific methods and procedures are only implemented to fulfill non-significant gaps in the clinical evaluation with the safety or performance of the device (e.g., use of equivalent device, gaps/bias with the clinical data available). Specific methods and procedures can be performed via evaluation of registers, PMCF investigation, patients survey, etc. and need to have the objective to collect clinical evidence to actively monitor the gaps discussed in the clinical evaluation report.

The PMCF activities are planned with the PMCF plan, documented with the PMCF evaluation report and should be independent to the PMS documents though the findings of PMCF activities should be discussed in the PSUR.

Importantly, PMS/PMCF documents are often defined in guidance documents. For instance, MDCG 2020-7, MDCG 2020-8 or MDCG 2022-21 in Europe, include templates to document the PMCF plan, PMCF evaluation report and PSUR. In Canada, the guidance document “Guidance on summary reports and issue-related analyses for medical devices” describes the format of the summary reports. It’s is crucial to understand the country-specific requirements and recommendations to meet the expectations of authorities.