The clinical evaluation report is a document that reports the clinical investigation conducted to prove safety and/or effectiveness of a medical device product.
It should be well written, clear, and easy to read. A good clinical evaluation report will provide enough details to guide consumers in making informed decisions about this product.
This blog is intended to give you tips on writing a very good clinical evaluation report for medical device products.
Purpose of Clinical Evaluation Report
The Clinical Evaluation Report is a summary of the clinical performance of a medical device. EU Authorized Representative It is intended for use by healthcare providers, regulatory authorities and other stakeholders in the decision-making process regarding the use of a device for clinical purposes.
The Clinical Evaluation Report covers the results of clinical evaluations performed under the responsibility of an independent third party (e.g., contract research organization), which may include:
- Pharmacokinetic studies (PK/PD)
- In vitro tests (e.g., cytotoxicity tests)
- In vivo animal studies
- Clinical trials, including phase I, II and III trials and post-marketing surveillance studies
Scope and Tasks of Clinical Evaluation Report
The scope of a clinical evaluation report for medical device products is to provide an overview of the evaluation process, including:
The clinical evaluation report provides a detailed description of the results of the clinical study. The following sections are included in this section:
In addition to the above-mentioned sections, the clinical evaluation report may also include other sections such as an objective summary diagram, study protocol and safety information.
Responsibilities for the Development of the Clinical Evaluation Report
The purpose of the Clinical Evaluation Report (CER) is to provide information on the performance of a medical device in clinical trials. This document is intended to be used by health care practitioners and others who are evaluating the safety and effectiveness of a medical device. Clinical Evaluation Report It is not intended as a substitute for any other information available about this device or other product candidates, nor does it represent an endorsement by FDA or any other agency.
Responsibilities for the Development of the Clinical Evaluation Report
The CER should be developed by a team that includes one or more clinical investigators, statisticians and/or regulatory affairs personnel who are familiar with the clinical trial design, data collection and analysis methods employed in the study(ies). The CER should include:
- A description of how the study(ies) were conducted including study population characteristics;
- An overview of methods used to analyze safety data (e.g., adverse events);
- A description of methods used to analyze efficacy data;
- Results from all types of analyses performed on safety data;
- Results from all types of analyses performed on efficacy data;
- Summary tables that compare primary efficacy variables against those observed in previous clinical trials for this product candidate.
Comments