Post Market Clinical Follow up (PMCF)

Stay compliant with EU regulations and ensure the ongoing safety and performance of your medical device with our Post-Market Clinical Follow-Up (PMCF) Template. This easy-to-use template is designed in accordance with EU MDR 2017/745, helping medical device manufacturers collect, analyze, and document post-market clinical data to demonstrate continued conformity with safety and performance requirements.

Key Features:

• EU MDR 2017/745 Compliant: Fully aligned with the requirements outlined in Annex XIV, Part B of the EU MDR, ensuring that your PMCF activities meet regulatory standards for ongoing clinical evaluation.
• Comprehensive PMCF Plan and Report Structure: Includes pre-structured sections to cover PMCF objectives, methods for data collection, clinical data analysis, and documentation of findings, all in line with EU MDR.
• Risk-Based Approach: Focuses on collecting and evaluating clinical data based on the device’s risk classification, intended use, and known or emerging risks, ensuring that the PMCF activities remain targeted and effective.
• Integration with Risk Management & PMS: The template includes sections to link PMCF results to your device’s overall Risk Management process (ISO 14971) and Post-Market Surveillance (PMS) plan, ensuring seamless integration across regulatory requirements.
• Suitable for All Device Classes: Whether your device is Class IIa, IIb, or III, this template is adaptable to all device classifications, active and non-active, Invasive and non-invasive, ensuring that your PMCF activities meet the specific risk and regulatory requirements.

Why Choose This Template?

• Regulatory Compliance Assurance: Designed to ensure your PMCF plan and report fully comply with Annex XIV, Part B of EU MDR 2017/745, helping you avoid delays and regulatory risks.
• Time-Saving & Efficient: Pre-structured sections guide you through the PMCF process, allowing for efficient collection and documentation of clinical data.
• Adaptable for Any Medical Device: Whether your device is a high-risk implantable or a low-risk Class I/IIa product, this template is flexible enough to address the unique clinical follow-up needs of any medical device.
• Audit-Ready Documentation: Prepare transparent and structured PMCF documentation that is ready for regulatory audits or notified body assessments.

What’s Included?

• Editable Template in Word format: Fully customizable to your specific device and PMCF activities, with clear instructions for completion.
• Pre-Structured Sections: Comprehensive sections covering all aspects of PMCF, including study objectives, methodology, clinical data collection, analysis, and conclusions.
• Guidance Notes: Step-by-step guidance on how to design, conduct, and document PMCF activities to meet EU MDR requirements with an example.
• Risk Management Integration: Includes a section to link PMCF data to ongoing risk management activities, ensuring a proactive approach to device safety.

Ensure Compliance with EU MDR 2017/745

This PMCF Report Template simplifies the process of documenting post-market clinical follow-up activities, ensuring that your medical device complies with the EU MDR 2017/745 and continues to perform safely and effectively in real-world use. With this template, you can ensure that your device’s clinical data is continuously monitored, analyzed, and documented for regulatory compliance.