GMED North America’s Training Center

The Clinical Evaluation Report (CER) Requirements Under the EU MDR 2017/745

Manage the CER process for updated and compliant clinical data

Save on tickets with Early Bird Special, Client and Bundle Discounts**

2 half-days or 1 full day of training | Virtual Classroom | $1250 pp

April 1-2, 2025
September 24-25, 2025

About the training

All medical devices sold into Europe, new or existing, and irrespective of specification, must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File. However, despite the CER being a critical compliance element for medical device manufacturers doing business in the EU, there continues to be a significant lack of clarity regarding key requirements and best practices for creating these reports. Without a clear understanding of what is required, both manufacturers and Notified Bodies (NBs) struggle to apply a consistent approach to the CER process.

Now that the new Medical Device Regulation (EU) 2017/745 has come into force in the European Union, there is an even greater emphasis on providing supporting clinical data, combined with the need to suitably plan CERs and fully document the approach and processes around it.

To seamlessly manage the CER process so that clinical data is regularly updated without causing major bottlenecks, or stalling, in productivity, it is critical that medical device manufacturers establish now a clear strategy towards their Clinical Evaluation Reports (CERs).

REQUIRED LEVEL

Good knowledge and effective practice of the Directives 93/42/EEC or/and 90/385/EEC.

Christopher Brodrick Design Dossier Evaluator, GMED North America

Christopher Brodrick is a Design Dossier Evaluator at GMED NA specializing in Cardiovascular and Neurovascular devices. He has a Master’s Degree in Biomedical Engineering from the University of Virginia, as well as a Bachelor’s Degree in Materials Engineering from Virginia Tech. His past roles have included Clinical Affairs Manager at another notified body, Senior Consultant within a large CE Mark consulting company, and he has worked in the cardiovascular device industry as a R&D Engineer. He has broad expertise in the area of Clinical Evaluation for CE Marking and is a frequent speaker and trainer on this topic.

Who Should Attend

Medical Device Manufacturers
Internal and external Auditors
Regulatory Affairs Managers and Quality Managers
R&D specialists
Development, Manufacturing and Marketing Managers

Learning Objectives

Identify the key changes for Clinical data under the Regulation (EU) 2017/745 (MDR)
Determine what is considered “sufficient” clinical data for clinical evaluations
Understand the Clinical Investigation Requirements
Identify the Post-Market Surveillance Requirements (PMS), the Post-Market Clinical Follow-Up (PMCF), and the Periodic Safety Update Report (PSUR)