To confirm the safety and performance throughout the expected lifetime of your medical device or IVD, this includes:
Verify that the device continues to meet its intended purpose under normal conditions of use.
Detect previously unknown side-effects and monitor the acceptability of identified risks.
Generate data to support Post Market Surveillance (PMS) and Clinical Evaluation Report (CER).
Your Post Market Clinical Follow-up Plan should include both general and specific activities with a clear goal for these activities.
What data are you looking to generate? Are the methods appropriate? To answer these questions, you need to consider the varied options of PMCF activity.
General activities are information gathering in nature – often general subjective data, which by themselves do not provide robust scientific evidence. They should be used in conjunction with specific activities.
Systematic review of published clinical data and scientific literature
Review of customer complaints and adverse event reports
Analysis of post-market surveillance and vigilance reporting
Gathering feedback from healthcare professionals and patients
Analysis of sales data and market trends
Review of similar devices and their post-market performance
Specific methods are tailored to generate scientifically significant datasets with defined purpose, population, and outcomes. When well executed, these activities provide robust data on your product's safety and performance.
Gold standard with defined protocols, population, sample size, and follow-up
Product-specific or larger registries capturing long-term real-world data
Flexible, case-specific surveys capturing patient outcomes and clinical data
Gold Standard Approach
Advantages & Challenges
Advantages: Long-term data, real-world settings, large populations
Challenges: High operational costs, limited reach, patient engagement difficulties, data relevance considerations
Most Utilized Tool
A comprehensive PMCF Plan outlines your post-market surveillance strategy, defining objectives, methods, timelines, and responsibilities to ensure continuous monitoring of your medical device's safety and performance.
Define clear, measurable PMCF objectives aligned with regulatory requirements and business goals.
Specify the mechanisms for ongoing surveillance and data gathering.
Establish realistic timelines for PMCF activities and reporting milestones.
Clearly assign roles and allocate necessary resources for successful execution.
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The PMCF Report is a critical regulatory document that synthesizes post-market surveillance data, demonstrating ongoing safety and performance of your medical device. It must be comprehensive, transparent, and aligned with EU MDR requirements.
Overview of PMCF activities, key findings, and conclusions regarding device safety and performance.
Reference to the approved PMCF Plan and any deviations or amendments made during execution.
Detailed results from all PMCF activities, including demographics, endpoints, adverse events, and clinical outcomes.
Comprehensive evaluation of adverse events, trends, and comparison to pre-market data and literature.
Updates to risk analysis based on post-market data, including any new hazards or mitigation strategies.
Clear conclusions on device safety and performance, with recommendations for continued monitoring or corrective actions.
Notified Bodies play a critical role in the PMCF process, reviewing and approving PMCF Plans and Reports to ensure compliance with EU MDR requirements and scientific rigor.
Notified Bodies assess the PMCF Plan for scientific validity, regulatory alignment, and feasibility before approval.
Ongoing oversight of PMCF execution to ensure adherence to approved plans and regulatory requirements.
Detailed review of PMCF Reports for data quality, statistical validity, and regulatory compliance.
Appropriate study design, sample size justification, statistical methods, and data quality assurance.
Adherence to EU MDR, ISO 14155:2020, GCP, and other applicable regulatory standards.
Complete reporting of results, including adverse events, limitations, and potential biases.
PMCF data integration with device risk analysis and mitigation strategies.
Get answers to the most common questions about PMCF requirements, planning, and execution.
PMCF is required for all medical devices under EU MDR, except for certain low-risk Class I devices without measuring functions. The extent and complexity of PMCF depends on the device classification, intended use, and identified risks. Notified Bodies assess whether PMCF is necessary during the conformity assessment process.
PMCF is a planned, structured post-market surveillance activity designed to generate specific safety and performance data. Pharmacovigilance, by contrast, is the passive monitoring of adverse events reported spontaneously by healthcare professionals and patients. While both are important, PMCF provides more robust, scientifically rigorous data.
PMCF duration depends on the device lifecycle and regulatory requirements. For many devices, PMCF continues throughout the device's market life. The PMCF Plan should specify the duration, but it may be extended or modified based on emerging safety signals or regulatory feedback. Regular review with your Notified Body ensures alignment with evolving requirements.
Yes, retrospective data collection is possible, particularly through patient surveys or registry analysis. However, retrospective data has limitations, including potential recall bias and incomplete records. Prospective PMCF activities are generally preferred for generating high-quality safety and performance data. A combination of prospective and retrospective approaches is often most effective.
If PMCF identifies a safety concern, you must immediately notify your Notified Body and relevant regulatory authorities. Depending on the severity, you may need to implement corrective actions, update labeling, or conduct additional studies. Transparent communication and timely action are essential to maintain regulatory compliance and patient safety.
PMCF Report submission frequency depends on your PMCF Plan and regulatory requirements. Typically, interim reports are submitted annually or at predefined milestones, with a final report at the end of the planned PMCF period. Your Notified Body will specify the exact reporting schedule during the approval process.
Pre-market clinical trial data cannot directly fulfill PMCF requirements, as PMCF focuses on real-world post-market performance. However, clinical trial data can inform your PMCF Plan design and serve as a baseline for comparison. PMCF must generate independent post-market evidence to demonstrate ongoing safety and performance in actual clinical use.
A CRO can provide end-to-end PMCF support, including study design, regulatory coordination, site management, data collection, analysis, and report writing. CROs bring expertise in study methodology, regulatory compliance, and quality assurance. However, the device manufacturer remains ultimately responsible for PMCF compliance and data integrity.
