2024年3月15日 · A Clinical Evaluation Report (CER) is a comprehensive document that summarizes the results of the clinical evaluation process for a medical device. It provides a detailed analysis of the clinical data collected, along with an assessment of the device's safety, performance, and intended use.

2022年10月4日 · According to the Regulation (EU) 2017/745, Article 61 and ANNEX XIV, the evaluation of the clinical performance and safety as well as the clinical benefit must be based on clinical data and is required for all medical device classes.

2025年1月3日 · The output of the clinical evaluation is the Clinical Evaluation Report (CER). It documents 1) your clinical evaluation process and its conclusions, demonstrating the acceptability of the device’s benefit-risk profile and 2) the device’s continued safety and efficacy.

The end result of this process is the production of a clinical evaluation report (CER). According to these guidelines, you arrive at this CER by the following process: • Identifying the essential requirements (ERs) that require support from relevant clinical data. • Identifying available clinical data relevant to the device and its intended ...

2023年11月2日 · Writing a medical device clinical evaluation report (CER) is the culmination of a monumental effort to conduct literature searches, find/review literature, and/or conduct original clinical investigations.

2023年5月8日 · In this article we are going to explain the significance of Clinical Evaluation Reports for medical device market access in 2023 and give you expert tips to write and validate a report that ensures your products are compliant with regulations.

2021年8月19日 · A clinical evaluation report is a comprehensive analysis of pre-market and post-market clinical data relevant to a medical device. A detailed CER report must back any medical device approved for sale in Europe.

A Clinical Evaluation Report (CER) documents the conclusions of a clinical evaluation and the clinical evidence for a medical device. A CER may contain clinical data from: Clinical investigation of the device under evaluation.

2024年9月30日 · Learn the fundamentals of a Clinical Evaluation Report (CER), its evolution under EU MDR, and strategies for ensuring compliance with medical device regulations.

2021年5月23日 · A Clinical Evaluation Report (CER) is a detailed summary of the evaluation of information pertaining to clinical use of a medical device. All sources of clinical data are considered, as well as certain non-clinical testing data that may affect the …