Understanding Clinical Evaluation: Benefit-Risk Analysis and Clinical Evaluation Reporting

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The era of treating the Clinical Evaluation Report (CER) as an afterthought is over. Under the EU Medical Device Regulation (MDR), your CER is now the indispensable foundation and key gateway for your European CE Marking technical documentation, even for low-risk medical devices. This comprehensive training course provides an in-depth guide to assembling and maintaining a compliant CER. Upon completion, you will possess the complete expertise to establish a robust clinical evaluation process within your Quality Management System (QMS) that is specifically designed to withstand rigorous Notified Body scrutiny.

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This training takes place in one of two formats (your choice): 

• Three-day in-person training (8 hours/day) located at your site

• Five-day remote online training (4 hours/day)

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Clinical Evaluation for Medical Devices Course Objectives:

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After taking this course, you will be able to:

• Describe EU MDR requirements for CERs and post-market clinical follow-up (PMCF)

• Define clinical data, clinical evaluation, and clinical evidence and their interrelationship

• Internalize the five stages of clinical evaluation from the MEDDEV 2.7/1 Rev. 4 guidance

• Develop an MDR and MEDDEV-compliant Clinical Evaluation Plan (CEP)

• Describe data collection processes for multiple data types

• Understand the interrelationship between the five stages of clinical evaluation, State of the Art, and the benefit-risk analysis

• Discuss several ways to analyze data for safety and performance

• Describe how various data types act as inputs to the benefit-risk analysis

• Identify the CER components and talk about what content belongs in each

• Describe the basics of clinical investigations under the EU MDR

• Define the relationship between post-market surveillance (PMS) and PMCF

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Who should take this course?

• Regulatory professionals who need to understand clinical evaluation

• Team members that require proof of training in Clinical Evaluation (certificate awarded at end of course)

• Medical Writers (consultants and in-house) looking to break into CER writing

• Recommended for professionals in QA/RA, R&D, Marketing, and any role associated with the device development and maintenance function

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Course Overview

 

Introduction to Clinical Evaluation and the MDR

• Structure of EU regulations and government

• Drivers behind updating of MDD/AIMDD to MDR

• Impact of new clinical evaluation requirements

 

Clinical Data

• Device claims and support

• Types of clinical data 

• Using clinical data to support performance and safety

 

The Clinical Evaluation Process

• Relationship between Clinical Data / Clinical Evaluation / Clinical Evidence

• Clinical evaluation process inputs and outputs

• The five stages of clinical evaluation

• Relationship between clinical evaluation and PMCF

 

Clinical Evidence

• Structure of clinical evidence

• Clinical evidence requirements

• How much clinical evidence is sufficient?

 

Components of a CER

• MDR requirements for CERs

• CER table of contents

• Aligning CER with five stages of clinical evaluation

 

Clinical Evaluation Planning

• MDR requirements for the CEP

• CEP pitfalls

• CEP workshop

 

Data Collection

• Clinical data in MDD vs. MDR

• Clinical and non-clinical data types

• Using clinical and non-clinical data to support safety and performance

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Data Appraisal and State of The Art

• The data appraisal process

• The State of the Art literature search and requirements

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Data Analysis

• Data analysis methods

• The clinical literature search

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Post-market Surveillance

• The PMS process relationship to the QMS and the CER

• MDR requirements for PMS

 

Benefit-Risk Analysis

• Types of benefits

• Characterizing and supporting benefits

• Analyzing benefits against risks

• The benefit-risk determination

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