Comprehensive Clinical Evaluation under MDR

Clinical Evaluation Reports (CERs) are a requirement for manufacturers wanting to place their Medical Devices in the EU market as it demonstrates compliance with the European Medical Device Regulation (EU) 2017/745 (MDR), however preparing one requires more than simply following a template. A robust CER must demonstrate critical appraisal of clinical evidence, appropriate use of the scientific literature, sound clinical reasoning and compliance with current regulatory expectations and guidance.

This interactive and comprehensive course will teach the Clinical Evaluation process from planning through to completion, using guidelines (MEDDEV 2.7/1 rev4), guidance documents (e.g., MDCG 2020-13) and standards (ISO 18969) allowing participants to gain practical knowledge of how to prepare, review and maintain CERs that meet regulatory expectations, while avoiding common deficiencies identified by Notified Bodies.

The course combines regulatory theory with practical exercises, real-world examples, group discussions and instructor-led sessions to reinforce learning and enable participants to apply the concepts within their own organisation.