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

The Clinical Evaluation Report (CER) Requirements Under the EU MDR 2017/745; 1-Day Session; April 1, 2026; Online Training

Schedule (all times EST): 9:00am - 5:00pm

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).

For program and more information, click here.