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PMCF plan requirements per MDR 2017/745

1. Introduction and Objectives

Define the purpose of the PMCF plan.

Specify the objectives of the PMCF activities.

Identify the intended users and patient populations.

2. PMCF Study Design

Determine the type of PMCF study (e.g., clinical study, registry).

Outline the study design methodology (e.g., observational, interventional).

Specify the study duration and follow-up periods.

3. Target Population and Sample Size

Define the target population for the PMCF study.

Determine the sample size based on statistical considerations.

Describe inclusion and exclusion criteria.

4. Data Collection Methods

Specify the methods for data collection (e.g., questionnaires, interviews).

Outline the data management procedures.

Ensure compliance with data protection regulations.

5. Risk Management Considerations

Identify potential risks associated with the device.

Outline how risks will be monitored and mitigated during PMCF.

Include a plan for reporting adverse events.

6. Data Analysis and Interpretation

Define the statistical methods to be used for data analysis.

Specify how data will be interpreted in relation to device safety and performance.

Plan for interim analyses if applicable.

7. Reporting and Documentation

Outline the reporting format and frequency.

Specify the stakeholders involved in the reporting process.

Ensure documentation meets regulatory requirements.

8. Updates and Revisions

Define the process for updating the PMCF plan based on findings.

Outline criteria for revising the PMCF activities.

Plan for continuous improvement of the PMCF process.

9. Budget and Resources

Estimate the budget for PMCF activities.

Identify personnel and resources required for implementation.

Allocate responsibilities among team members.

10. Compliance with Regulatory Requirements

Ensure alignment with MDR requirements for PMCF.

Review any applicable national regulations and guidelines.

Confirm the PMCF plan is approved by relevant authorities.

This checklist serves as a comprehensive guide for engineering organizations to develop a PMCF plan in compliance with MDR 2017/745.

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