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Retrospective PMCF Study

A retrospective PMCF study involves collecting and analysing existing data previously gathered from the use of the medical device. This study leverages historical data from patient records, registries, and other sources.

Advantages and Disadvantages of Retrospective Study



  1. High-Quality Data: Researchers can design data collection protocols to ensure consistency and completeness.
  2. Time Efficiency: Retro PMCF studies can be conducted relatively quickly as the data already exists. The analysis phase can start immediately without waiting for new data collection.
  3. Cost-Effective: Since no new patient recruitment or additional clinical procedures are required, the study is less expensive. Existing infrastructure can be used to gather data, minimizing costs.
  4. Large Data Sets: Utilizing existing databases or registries can provide access to large and diverse patient populations, enhancing the statistical power and generalizability of the study results.
  5. Real-World Evidence: The data reflects the actual use of the device in everyday clinical practice, offering insights into its performance and safety outside the controlled conditions of a clinical trial.




  1. Data Quality and Completeness: Historical data may be incomplete, inconsistent, or of varying quality, which can affect the reliability and accuracy of the study findings.
  2. Lack of Control: Researchers have limited control over how the data was originally collected, potentially leading to biases and confounding variables that are difficult to account for.
  3. Retrospective Bias: The study design can introduce selection bias, as it only includes data from patients who were already treated with the device, potentially excluding relevant patient populations.
  4. Regulatory Acceptance: Some regulatory bodies may prefer prospective data, viewing retrospective studies as less robust due to potential biases and lack of control over data collection methods.

Our experts developed PMCF Plan templates, and SOP, in line with EN ISO 13485:2016, Section 8.2.1 and MEDDEV NB-MED/2.12/Rec.1 guideline. During the preparation of the MDR Technical Documentation File, the clinical evaluation report should be concluded with the help of appropriate PMS Procedure, relevant SOPs, templates and a report with its conclusion.

Conducting Retrospective PMCF Studies

  • Data Collection: Historical data is gathered from various sources such as medical records, EHRs, device registries, and insurance claims databases. This process involves identifying relevant data points, extracting them from existing records, and compiling them into a usable dataset.
  • Data Analysis: Statistical analysis is performed to evaluate the device’s performance, safety, and any adverse events. This analysis can include methods such as survival analysis, regression analysis, and comparative studies to derive meaningful insights from the collected data.

Retrospective PMCF Study Process

  • Study Design: Define the study protocol, including objectives, endpoints, and data collection methods. This involves developing a detailed plan that outlines the study’s aims, the criteria for patient selection, and the procedures for data collection and analysis.
  • Patient Recruitment: Enroll patients who meet the inclusion criteria. This step involves identifying and recruiting participants who fit the study’s predefined criteria, ensuring a representative sample for the study.
  • Data Collection: Collect data as patients use the device, following the study protocol. Data is gathered in real-time, capturing detailed information on the device’s performance and any adverse events.
  • Data Monitoring: Continuously monitor the data for quality and completeness. Regular monitoring ensures that data is being collected accurately and consistently, allowing for timely identification and resolution of any issues.
  • Data Analysis: Perform statistical analysis on the collected data. This step involves analyzing the data to assess the device’s performance, safety, and any observed trends or patterns.

As a leading global medical device regulatory services provider, the I3CGLOBAL team is always ready with the resources to support your organization in EU MDR regulations covering PMS, PMCF, and PSUR Reporting through Clinical Documentation.

Frequently Asked Questions

What the major data collection methods?

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