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