Post market clinical follow-up (PMCF) is a proactive, systematic process conducted by manufacturers to collect and evaluate clinical data on a device’s performance and safety after it has been placed on the market.
This is mandated under Part B Annex XIV of the EU MDR. This is intrinsically connected with the vigilance system as well as with the reporting of incidents and together creates a framework for monitoring device performance and promptly approaching each risk that arises.
By analysing the interconnection of all these elements, the manufacturers as well as notified bodies can ensure that ongoing compliance and safety for patients are maintained.
The Vigilance System
The vigilance system is a critical component of the Post market surveillance (PMS) framework under the EU MDR. It is designed to facilitate the reporting, evaluation, and management of incidents and safety-related issues involving medical devices. Manufacturers should report serious incidents and Field safety corrective actions (FSCAs) to the competent authorities according to Article 87 of the EU MDR.
In case of serious public health threat, the report shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat. If a person dies or has an unanticipated significant decline in their health, the report must be given as soon as the manufacturer has established or suspects a link between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware it.
Integration of PMCF with Vigilance and Incident Reporting
PMCF activities and the vigilance system are complementary mechanisms that ensure a continuous feedback loop for the safety and performance of medical devices.
- Data Collection and Trend Analysis
PMCF generates real-world evidence through methods such as observational studies, registries, surveys and feedback from healthcare professionals. These data sources provide insights into device performance under routine clinical practice. In combination with vigilance data like incident reports, near-misses or adverse events, manufacturers may use PMCF to identify patterns and trends that will alert them about potential safety problems. PMCF might show that a higher incidence of device malfunctions in a specific clinical setting, which can lead to further investigation through the vigilance system. Data collected during PMCF, feeds into the vigilance system’s trend analysis. Identifying an increase in adverse events through PMCF can prompt further investigation and, if necessary, corrective actions.
- Incident Identification and Root Cause Analysis
PMCF activities often serve as a mechanism for early detection of incidents. A registry study may identify unforeseen adverse events that were not evident in the pre-market clinical trials. These events are then reported through the vigilance system, and a root cause analysis is performed. MEDDEV 2.12/1 Rev. 8 provides guidance on how to classify and report incidents emphasizing that PMCF data should be used to update incident reporting criteria and improve the quality of root cause investigations.
- Risk Management and Preventive Actions
Both PMCF and vigilance contribute to the dynamic risk management process required under the EU MDR. PMCF data provides manufacturers with information to confirm, update, or validate previous risk analysis in that it helps to confirm identified risks, new ones, and assess the efficiency of implemented mitigation measures. During the reporting of incidents through vigilance, PMCF findings guide field safety corrective actions (FSCAs) or the Instructions for use (IFU) for a device. This allows manufacturers to identify and apply mitigations before a problem escalates to a reportable incident. This proactive approach complements the reactive nature of traditional vigilance systems.
- Reporting Obligations and Regulatory Compliance
Under EU MDR the manufacturers are obligated to report serious incidents to the competent authorities within specific timelines. If a serious risk is identified manufacturers must inform users and take necessary corrective actions. They may include recalls or safety alerts, which must also be reported to the relevant authorities. The EU MDR mandates that manufacturers integrate findings from PMCF and vigilance into their Periodic Safety Update Reports (PSUR) for Class IIa, IIb, and III devices. These reports must include a summary of PMCF finding, an analysis of incident trends, actions taken to address identified risks.
Conclusion
The integration of PMCF activities with the vigilance system and incident reporting is a crucial aspect for ensuring the safety and effectiveness of medical devices in the EU market. Manufacturers will be able to proactively detect and manage risks, improve patient safety, and maintain regulatory compliance by aligning their vigilance and PMCF processes. This proactive approach is critical, given that issues related to medical devices may not always be immediately apparent during pre-market evaluations. A key advantage of integrating PMCF and vigilance is that manufacturers can gather a comprehensive dataset that encompasses both clinical performance data and incident reports. This helps them identify emerging risks early, make data-driven decisions, and mitigate the chances of unsafe or ineffective devices reaching patients. As the regulatory framework continues to evolve, leveraging advanced technologies such as Artificial intelligence (AI) and Machine Learning (ML) and innovative approaches like patient centric reporting systems, risk-based monitoring etc are essential in addressing existing challenges and ensuring that patient safety remains at the forefront of medical device monitoring and regulation.
Dr Shrinidhi Ballal, MDS
Jr. Consultant at i3cglobal