Post-Market Surveillance (PMS) is defined as a structured process for monitoring the safety and performance of a medical device following its release onto the market. PMS consists of two key components: Post-Market Clinical Follow-up (PMCF) and Vigilance.
Although they may look similar, they serve distinct purposes and have different methodologies under the EU Medical Device Regulation (MDR) framework. Here’s the breakdown of each:
1. Purpose
PMCF
The primary purpose of PMCF is to collect clinical data after a device is on the market to confirm its safety and performance in the real-world population as per its intended use. PMCF aims to provide ongoing clinical evidence of the device’s effectiveness and detect any emerging clinical risks.
It is part of the clinical evaluation process and is used to update the Clinical Evaluation Report (CER) to ensure that the benefit-risk profile of the device remains acceptable over the device lifetime.
Vigilance
Vigilance refers to the process of monitoring, detecting, and reporting adverse events or incidents involving a medical device after it has been placed on the market. The purpose of vigilance is to identify serious incidents or potentially harmful events that may occur with the device to implement corrective actions and minimise risks to patients and users.
2. Scope and Methods
PMCF
PMCF is a proactive process focused on collecting clinical data related to the performance and safety of the device. it often involves conducting clinical studies (ongoing trials or post-market clinical studies), gathering data from registries, reviewing clinical literature, or following up with healthcare providers to collect clinical insights and evaluate ongoing clinical performance and risks.
PMCF is specifically designed to provide evidence for ongoing clinical evaluation.
Vigilance
Vigilance is a reactive process with a broader scope. It is triggered by adverse events or reported incidents and encompasses all aspects of device safety. It includes identifying issues such as injuries, infections, device malfunctions, or failures that could pose safety risks.
3. Regulatory Reporting
PMCF
PMCF is a planned, systematic activity documented in a PMCF Plan, which outlines objectives, methodology, and timelines for clinical follow-up.
Results are reported through PMCF Reports and included in the Post-Market Surveillance Report (PMSR) or Periodic Safety Update Report (PSUR), which summarize the device’s safety and performance based on PMS activities.
Vigilance
Vigilance involves mandatory reporting of serious incidents and device failures to the relevant competent authorities in the EU. Manufacturers are required to report incidents through the European Medical Device Vigilance System (EUDAMED) or directly to the competent authorities.
Vigilance activities are often triggered by adverse event reports from users, healthcare professionals, or consumers, and the manufacturer must investigate and, if necessary, implement corrective or preventive actions (CAPA). The summary of the vigilance activities and CAPA will be included in Post-Market Surveillance Report (PMSR) or the PSUR, depending on the risk classification of the device.
2. Outcome and Actions
PMCF
The outcomes of PMCF help update the Clinical Evaluation Report and support the ongoing clinical benefit-risk analysis.
Also, if new clinical risks are identified, PMCF findings may lead to updates in labelling, device modifications, or additional clinical investigations.
Vigilance
The outcome of vigilance activities may include the recall of a device, the issuance of Field Safety Corrective Actions (FSCA), or warnings about the device’s safety issues. Vigilance findings are often linked to risk mitigation and corrective actions to ensure patient safety.
| Focus | Clinical data collection to evaluate safety and performance | Monitoring and reporting safety incidents and adverse events |
|---|---|---|
| Scope | Clinical performance and risks | Safety incidents (e.g., malfunction, adverse events) |
| Approach | Prospective (clinical studies, registries) | Reactive (triggered by reported incidents) |
| Methodology | Clinical follow-up, post-market studies | Adverse event reporting, trend analysis |
| Reporting | PMCF Report, PMSR/PSUR, Clinical Evaluation Report | Reporting to regulatory authorities, PMSR/PSUR, Clinical Evaluation Report |
| Outcome | Update Clinical Evaluation, support CER, identify emerging risks | Corrective actions, device recall, safety measures |
Key takeaways
PMCF is a proactive clinical follow-up activity that focuses on gathering clinical data to support ongoing evaluation of the device’s safety and performance.
Vigilance is a reactive safety monitoring system focused on identifying and reporting adverse events and device malfunctions to ensure the safety of patients using the device.
Both are essential components of the PMS system, but they address different aspects of post-market monitoring and serve different regulatory and safety objectives. Mantra Systems are well-equipped to advise on all aspects of MDR work, so get in touch now if you need help.
