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Clinical Evaluation Report

Scientific Communications

Clinical Evaluation ReportA 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 benefit-risk analysis for the device. All of the information taken together provides a thorough understanding of the safety and effectiveness of your device for its intended use.

We create clinical evaluation reports, in partnership with the manufacturer, to provide a complete picture of clinical use of your device. To ensure the clinical evaluation report is comprehensive, we compile and synthesize information from wide-ranging sources, including:

  • Description of device and its use, along with regulatory history and device classification
  • Summary of clinical background for your device and its intended use(s)
  • Systematic, documented searches of available literature and medical reports to create a thorough review and evaluation of the relevant state of the art
  • Demonstration of equivalence to other device(s), based on technical, biological, and clinical characteristics, if applicable
  • Summary of nonclinical testing data
  • Systematic, documented searches of post-market surveillance data, clinical study reports, and other clinical data to create a comprehensive review of clinical experience of your device (or equivalent)
  • Medical review of the clinical evidence
  • Summary of device usability data
  • Appraisal of the relevance, applicability, quality, and significance of the available data
  • Explanation of the methods and parameters used to assess clinical benefits, safety, and the benefit-risk ratio
  • Summary of benefit-risk determination

Based on the evidence gathered, we can identify potential gaps where notified bodies may want to see additional information. We have experience in developing evidence that can fill those gaps in your clinical evaluation report. This involves creation (in collaboration with the client) or update of a post-market clinical follow-up (PMCF) plan, which may include:

  • Development of clinical studies to gather additional clinical evidence
  • Identification of potential sources of real world data (e.g., registries and electronic health data from health care providers) that can generate real world evidence (RWE) as a relatively cost effective alternative to clinical studies (an especially promising option for legacy devices)
  • Design of post-market surveillance activities or registries

MED Institute can also assist with the transition from European Union (EU) Medical Devices Directive, MEDDEV 2.7/1, to Regulation (EU) 2017/745 (known as EU-MDR). We assess the following to ensure the new requirements are met:

  • Classification of current device(s) and whether it has changed
  • Establishment and/or development of a clinical evaluation plan
  • Demonstration of conformity to the relevant MDR General Safety and Performance Requirements

Ultimately, we can help you develop clinical evaluation plans and reports to maintain compliance with the latest European regulatory requirements.

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