Systematic Literature Review for Medical Devices

Systematic Literature Review for Medical Devices; 1-day online training session; September 23, 2026.

About the training

Training Time: 1-day sessions: 9:00 am - 5:00 pm EST

All medical devices marketed in Europe and UK must have an up-to-date Clinical Evaluation Report (CER) as part of its Technical File. However, despite the CER being essential, there continues to be a 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 high quality, relevant, supporting clinical data, combined with the need to plan CERs and fully document the approach and processes around it.

A critical evaluation of the relevant scientific literature is one essential element of the CER. For many medical devices it is the main, or only, source of relevant clinical data. For many medical devices this will require at least two systematic reviews of literature in every CER. This course will cover why, when and how to undertake this systematic scientific process.

For program and more information, click here.