18-Hour Writing Clinical/Performance Evaluation Reports

18-Hour Writing Clinical/Performance Evaluation Reports is organized by Barnett International and will be held from Jan 14 - Apr 01, 2026.

Course Description:
Elevate your regulatory expertise and gain a competitive edge in the medical device industry with our comprehensive course on Clinical and Performance Evaluation Reports for markets outside the US. This course examines Clinical/Performance Evaluation Reports (CER/PER) requirements for EU MDR and IVDR (EU Reg 2017/745 and 746, respectively) and associated guidelines. The course curriculum also includes a peek at CER/ PER regulations outside the US. International and EU markets mandate the requirement to have a CER/PER for all medical device products. This program focuses on helping learners master effective evaluation and writing skills with techniques provided to ensure good CER/PER development and a clear understanding of potential reviewer comments with strategies to address Notified Body deficiencies if any have been noted in the past. This course will include interactive sessions, encourage participant experience sharing and will address specific CER/PER inquiries.

Learning Objectives:

• Analyze CER/PER development and evolution as the device matures
• Interpret EU MDR (EU Reg 2017/745 and 746) CER/PER requirements and associated guidelines
• Construct CER/PER development work plans
• Identify critical CER/PER elements for Notified Body evaluation
• Apply CEP/PEP template (provided) for plan completion
• Use CER/PER template (provided) for report completion
• Implement PMCFP/PMPFP template (provided) for plan completion
• Formulate responses to expert CER/PER reviewer critiques to learn more

Course Outline:

• Module 1: Introduction and CER/PER Requirements
• Module 2: Planning Clinical/Performance Evaluations
• Module 3: Identifying Clinical/Performance Data
• Module 4: Appraising Clinical/Performance Data
• Module 5: Analyzing Clinical/Performance Data
• Module 6: Establishing Clinical Benefit-Risk Ratios
• Module 7: Writing Clinical/Performance Evaluation Documents
• Module 8: Writing SSCPs/SSPs
• Module 9: Reviewing CE/PE Documents
• Module 10: Integrating CE/PE, PMS and RM Systems
• Module 11: Understanding CER/PER Regulations Outside of Europe
• Module 12: Forecasting CER/PER Future Directions