Periodic Safety Update Report (PSUR)

Enhance your post-market surveillance strategy and ensure regulatory compliance with our Periodic Safety Update Report (PSUR) Template, designed in accordance with EU MDR 2017/745. This comprehensive and customizable template provides a structured approach to documenting safety and performance data for your medical device throughout its lifecycle, facilitating ongoing risk management and regulatory reporting.

Key Features:

• EU MDR 2017/745 Compliant: Fully aligned with the requirements set forth in Article 86 and Annex III of the EU MDR, ensuring your PSUR meets the necessary regulatory standards for ongoing safety assessments.
• Comprehensive Reporting Structure: The template includes pre-structured sections to address all required elements, including safety data, benefit-risk analysis, and updates on post-market surveillance activities.
• Data-Driven Analysis: Guidance on collecting and analyzing clinical and post-market safety data, enabling you to present a thorough overview of the device's performance and any identified risks.
• Integration with Risk Management: Includes sections to connect PSUR findings to your overall Risk Management process, ensuring continuous monitoring and mitigation of risks throughout the device's lifecycle.
• Adaptable for All Device Classes: Suitable for all classes of medical devices (Class I, IIa, IIb, and III), allowing you to tailor the template to your specific device and market requirements.

Why Choose This Template?

• Regulatory Compliance Assurance: Ensures your PSUR is compliant with EU MDR 2017/745, helping to prevent regulatory issues and enhance device safety.
• Time-Saving & Efficient: Pre-structured sections guide you through the PSUR preparation process, allowing for quick and efficient documentation of required safety data.
• Versatile for Any Medical Device: Whether your device is high-risk or low-risk, this template is flexible enough to address the specific safety reporting needs of all medical devices.
• Audit-Ready Documentation: Prepare clear, organized, and traceable PSUR documentation that is ready for audits or regulatory inspections.

What’s Included?

• Editable Template in Word format: A fully customizable document that can be tailored to your specific device and safety reporting activities.
• Pre-Structured Sections: Comprehensive sections covering all aspects of the PSUR, including safety data collection, benefit-risk analysis, and conclusions.
• Guidance Notes: Step-by-step instructions and examples for completing each section of the PSUR, ensuring clarity and compliance with regulatory expectations.
• Data Integration Tools: Tools for integrating clinical data, adverse event reports, and post-market surveillance findings into the PSUR.

Ensure Compliance with EU MDR 2017/745

Our PSUR Template simplifies the process of compiling and documenting essential safety information, ensuring your medical device complies with EU MDR 2017/745 and continues to be safe and effective in real-world use. By utilizing this template, you can ensure your PSUR is comprehensive, compliant, and effectively supports ongoing risk management.