Post Market Surveillance and Post Market Clinical Follow Up Plan

In the medical device industry maintaining high standards of product safety, efficiency and compliance is not only a legal obligation but a commitment to patient safety and innovation.

European Union Medical Device Regulation (EU MDR 2017/745) and ISO13485 emphasizes the importance of post-market surveillance (PMS), Post-market clinical follow-up (PMCF) and corrective and preventive action (CAPA) in ensuring safety and effectiveness of the device once they are marketed.

CAPA is a cornerstone in achieving this goal by addressing identified issues and mitigating potential risks. When integrated into PMS and PMCF systems, CAPA becomes an important tool for continuous product improvement and compliance.

CAPA according to Article 2(67) of EU MDR are the key components to continuous improvement to correct and eliminate the causes of noncompliance and to prevent a potential noncompliance from occurring. They should be comprehensive, outlining the actions identified to address the root causes and should describe any related preventive actions.

CAPA can be related to:

• Devices already placed on the EU market.
• Issues that might have a direct impact on the product and that might impact product safety, performance or quality and,
• Any action related to a voluntary and non-temporary suspension of marketing of the device by the manufacturer which is not related to a commercial decision.
• Evaluation of benefits and risks identified through post-market activities as described in Annex III, point 1 (a) of MDR, i.e. in particular:
• Records referring to non-serious incidents and data on any undesirable side-effects.
• Relevant specialist or technical literature, databases and/or registers.
• Information, including feedback and complaints, provided by users, distributors and importers and,
• Publicly available information about similar medical devices.

Role of CAPA in PMS and PMCF

The CAPA findings are central to the development of the PMS and PMCF. When issues are identified post market, CAPA procedure helps identify necessary corrective actions, which may result in updating the PMS or PMCF process. Here is how the CAPA findings suggest updating these plans:

Identification of emerging risks

CAPA investigations often uncover the root causes of emerging risks that were not identified or anticipated at the time of the pre-market stage or during the original PMS or PMCF process.

If device malfunctions or adverse events occur CAPA can identify the root cause, which could be design flaws, material defects, or manufacturing defects. Once it is detected then the PMS plan needs to be updated to track the identified risks.

Similarly, if CAPA reveals new clinical data related to device performance, the PMCF plan may need to be revised to include additional follow up studies, additional patient groups, or extended data collection assess the impact of these emerging risks.

Changing data collection strategies

CAPA investigations may reveal differences in the data collected during the initial PMS and PMCF activities.

CAPAs findings may reveal that medical device-related adverse events were inadequately captured in existing surveillance systems, perhaps due to inaccurate reporting, lack of knowledge, insufficient clinical follow up.

To address this, the PMS plan can be updated to incorporate more robust data collection methods, including expanding the sample size, increasing the frequency of reporting, or using alternative data sources such as registries or patient surveys.

For PMCF, CAPA findings may indicate that additional data points need to be collected to assess the long-term safety of the product, especially if issues arise that were not fully understood at earlier stages. Updates to the PMCF plan may include new clinical studies, longer follow-up periods, or specific post-market trials to monitor patients for additional risks that were not previously considered.

Enhancing risk management

A key component of CAPA is the identification and mitigation of risks. If CAPA findings provide a deeper understanding of device risk, this insight should be reflected in the risk management process.

For example, if CAPA findings identify potential safety risks not originally considered in the risk assessment, the risk assessment in the PMS process should be updated to reflect this new information.

In addition, the PMCF plan should be updated to include measures to mitigate or manage any identified risks. This may involve adding new clinical trials, modifying standards of care, or developing strategies to support patients. The risk management process must be proactive and responsive to CAPA findings, ensuring that the operation of the tool remains safe and effective over time.

A review of post-market performance indicators

CAPA findings can indicate the post market performance indicators (PMIs) identified in the PMS or PMCF plan are insufficient or inaccurate. If a specific performance indicator fails to identify a recurring problem or trend demonstrated in a CAPA investigation, these indicators may need to be reviewed.

The PMS system may need a more specific or flexible assessment process and to capture subtle changes in the product security profile.

For PMCF, this may mean changing clinical endpoints, expanding the clinical trial, or encouraging frequent assessments of patients using the device. Recalibrating PMIs based on CAPA findings can ensure both PMS and PMCF planning goes provides meaningful and practical information.

Stimulating corrective and preventive measures

The CAPA process is a corrective approach, with identified issues leading to corrective and preventive actions. If such actions are initiated, they may change the design, manufacture, or labelling of the product, which then requires updates to the PMS and PMCF systems. If a corrective action involves changing the materials used in a device, the updated PMS plan may need to include additional monitoring to assess the impact of the new materials on safety and performance. If corrections to be made involve resource consumption in the case of replacement of a device further monitoring may be required to assess the impact.

Similarly, if preventive measures require labelling changes to make users more aware of certain hazards, the PMCF system may need to expand its scope to determine whether new labelling leads to changes in patient outcomes or clinical practice. Both plans need to be modified to ensure that corrections and preventive measures are properly tested in the aftermarket phase.

Conclusion

CAPA findings play an important role in guiding updates to PMS and PMCF plans. Through its ability to identify emerging risks, gaps in data collection, and risk management deficiencies CAPA findings inform necessary changes to ensure that medical devices remain safe and effective over their lifecycle. By optimizing PMS and PMCF systems in response to CAPA findings, manufacturers can proactively address issues, improve device performance, and safeguard patient health. Continuous learning and adaptation through CAPA-driven updates to post-market strategies ensure medical devices remain compliant with regulatory standards and meet the highest standards of quality and safety.

References

· Tashi T, Mbuya VB, Gangadharappa HV. Corrective action and preventive actions and its importance in quality management system: A review. International Journal of Pharmaceutical Quality Assurance. 2016;7(1):1–6.

· MDCG 2022- 2021: guidance on periodic safety update report (PSUR) according to regulation (EU MDR) 2017/745.

· MDCG 2024–12 Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams

Dr. Shrinidhi Ballal, MDS

Jr. Consultant at i3cglobal