What Is A Clinical Evaluation Report (CER)?
By Jennifer Daudelin, Director, MedTech Regulatory / Quality

The Clinical Evaluation Report (CER) is a pivotal document in achieving and maintaining CE Marking under the European Union’s Medical Device Regulation (EU MDR). Evolving from its earlier framework under the Medical Device Directive (MDD), the CER now requires a more rigorous and comprehensive evaluation of clinical data, emphasizing safety and performance benchmarks. Key changes include stringent requirements for equivalence claims, necessitating robust comparisons and legal rights to use clinical data from similar devices.
Under EU MDR, the CER integrates data from clinical studies, literature reviews, risk management, and post-market surveillance. Developing a CER involves establishing clinically meaningful benchmarks based on State of the Art (SOTA) and addressing any data gaps. Tailored strategies, aligned with the device's unique characteristics, ensure compliance and robust evidence generation. By focusing on thorough planning and precise execution, manufacturers can navigate EU MDR requirements effectively, ensuring device safety, performance, and regulatory success.
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