CER Critical Concepts

Clinical Evaluation Report Critical Concepts: Effectively Telling the Story of the CER – Focus on S&P Objectives, Acceptance Criteria, Clinical Benefits and Risk-Benefit Analysis

Safety and performance objectives…..clinical outcomes…..clinical benefits…..acceptance criteria…..risk-benefit ratio. These terms represent key concepts of the Clinical Evaluation Report (CER), yet confusion still exists on how to effectively identify, present and analyze these parameters within the context of an MDR-compliant CER. How do they tie together? How do they help you “tell the story” of the CER?

Click here to watch the recording of this session.

Presented from the point of view of seasoned MDR-compliant CER medical writers, this session will take a practical approach to:

• Define each of these concepts and their relationship to each other
• Develop MDR-aligned safety and performance objectives
• How clinical outcomes are leveraged in the CER and how they are different from S&P objectives
• Tying it all together in the Risk-Benefit section of the CER (hint: this section is where it all comes together)

There will be time at the end of this session to ask questions. Please submit your questions ahead of time while registering for this session so we have ample time to answer them thoughtfully. You may choose to send in your questions during the presentation as well.

Who is this forum for?

Those Regulatory, Quality and Clinical leaders and teams who develop, write, review, or approve clinical evaluation reports for MDR submissions. Anyone interested in learning more about MDR requirements for CERs is also welcome to attend. Also, we encourage professionals from the IVD industry to attend as well, as the content is also relevant to IVDR requirements, which align closely with MDR.

Critical Concepts: Measurable Objectives and Acceptance Criteria

This white paper is a companion piece to our popular webinar where we cover strategies to verify device safety and performance in the clinical evaluation of medical and in vitro diagnostic (IVDs) devices. This white paper should help you with identifying meaningful safety and performance measures for clinical or performance evaluation and with defining acceptance criteria parameters to determine the acceptability of benefit-risk as mandated by Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Regulation (IVDR) 2017/746.

Establishing your device’s safety and performance is a critical component of the clinical evaluation process. However, how to use the state of the art section within the Clinical Evaluation Report (CER) and Performance Evaluation Report (PER) to establish the device’s safety and performance objectives and acceptance criteria can seem ambiguous.

Download the full white paper here.