💡CLINICAL EVALUATION REPORT
In the realm of medical devices, a well-structured Clinical Evaluation Report (CER) is an indispensable document that scrutinizes pre-market and post-market clinical data. It assesses both clinical performance and safety, offering a comprehensive evaluation of relevant clinical data to ensure the device’s adherence to regulatory requisites. In this post we will give you some aspects to consider and practical tips for writing a compliant clinical evaluation report. Interested? Keep on reading.
Stage 0: SCOPE AND PLAN
Understanding the anticipations of a Notified Body for medical devices is paramount. A solid starting point is employing the Clinical Evaluation Report template (MDCG 2020-13) developed by the MDCG Group, which outlines the essential sections and details necessary for a Notified Body submission. Additionally, leverage available guidance, including typical specifications, MDR harmonized standards, international standards, and MDCG guidance documents. Remember, quantifying your benefit-risk ratio substantiates your performance claims effectively.
Stage 1: IDENTIFICATION OF THE DATA
Discerning between pre-market and post-market clinical data is crucial. Classifying these data sets, including clinical data from investigations and other sources, ensures a well-structured CER. For data that doesn’t fit these categories, a rationale should be provided for its inclusion.
Stage 2: APPRAISAL OF CLINICAL DATA
Thoroughly assess each identified data set for scientific validity and relevance to the clinical evaluation. To ensure a comprehensive assessment, use at least two literature and adverse event databases. This approach offers a holistic understanding of the device’s safety and performance within the market landscape.
Stage 3: ANALYSIS OF CLINICAL DATA
The analysis phase encompasses key elements such as the benefit-risk profile, residual risks, and uncertainties or unanswered questions. A comprehensive exploration of these aspects contributes to a robust evaluation.
Stage 4: FINALIZING THE CER
Concluding the data analysis phase, the CER should succinctly summarize the findings. This summary plays a pivotal role in presenting compelling clinical evidence to facilitate the device’s approval for European market distribution. This final stage encompasses a range of data sets, including:
- Technical documentation
- Post-Market Surveillance (PMS) reports
- Post-Market Clinical Follow-up (PMCF) data
- Risk management files
- Clinical data
- Clinical literature
Be OBJECTIVE. Every assertion made within a clinical evaluation report should be firmly grounded in scientific evidence. Objectivity is paramount; therefore, ensure that each claim is substantiated by accurate references.
Drafting a compliant Clinical Evaluation Report demands meticulous planning, a keen understanding of regulatory expectations, and a judicious assessment of clinical data. Following these practical tips can significantly enhance the quality of your CER, ultimately leading to successful approval for European market distribution.
A post by:
Carmen Martin (Senior Principal)
Maria Palacios (Medical devices Manager)
📌For more information about our comprehensive clinical evaluation process services, please contact us at [email protected]. Our team of experts is dedicated to ensuring your medical device regulatory compliance journey is seamless and successful.
