Clinical Evaluation Documentation
Benefits of appointing I3CGLOBAL
MDR Clinical Evaluation Documentation
Here is an overview of how Clinical Evaluation Documentation can be done in accordance with MDR:
- Define the Scope of the medical device: The clinical evaluation plan should clearly define the device’s scope, intended use, patient population, and clinical indications. It should outline the methodology, conclusion, and documentation of the evaluation process, as well as provide clinical data certifying device compliance with safety and performance requirements.
- Collect Clinical Data: Collect clinical data from pre-market investigations, clinical trials, scientific literature, post-market surveillance, and adverse event reports. Document each data set, covering the device’s entire life cycle, for a comprehensive evaluation report.
- Literature review: Perform a thorough review of the existing scientific literature to identify and analyze the relevant studies and reports. Consider clinical data related to similar devices or equivalent technologies. Describe the clinical background and identify the current knowledge or state of the art corresponding to the particular medical device. If equivalency is claimed, the validity of the criteria used for the demonstration of equivalence should be determined.
- Appraisal of pertinent data: The evaluators should evaluate each document individually in terms of its contribution to the assessment of the clinical performance and clinical safety of the device to ascertain the value of the data found in the literature search.
- Analysis of pertinent data: The analysis stage’s objective is to ascertain whether, when a medical device is used in accordance with its intended purpose, the appraised data sets available for the device collectively demonstrate compliance with each of the Essential Requirements pertaining to the clinical performance and clinical safety of the device.
- Risk-Benefit Analysis: Perform a risk assessment to identify potential hazards and risks associated with the device. Describe the measures taken to mitigate, control, or eliminate these risks. It also helps to identify the potential risk associated with the device as well as identify the benefits of using the device and make sure whether the benefits overweigh those risk.
- Clinical Evaluation Report (CER): A CER is an important technical document in the technical file which summarizes the clinical evaluation of a medical device. A clinical evaluation report should document the evaluation and its output, providing detailed search criteria, available data, assumptions, and conclusions. Create a Clinical Evaluation Report by compiling the clinical evaluation’s findings (CER). A Clinical Evaluation Report (CER) is a comprehensive, well-documented, and structured appraisal of clinical evidence to assess the safety and performance of a medical device. The CER should be kept up-to-date and reviewed at regular intervals.
- Consult with experts: To ensure the thoroughness and accuracy of the evaluation, seek input from qualified experts such as clinical specialist, statisticians, and regulatory affairs professionals. We must include the CV and declaration of interest of clinical evaluators along with the clinical evaluation report.
- Submit to Regulatory Authorities: In compliance with the guidelines and regulations of the appropriate regulatory body, prepare and submit the Clinical Evaluation Report. In order to approve or maintain the device’s market presence, the notified body will examine the report.
- Post-Market Surveillance: After the product is put on the market ,keep an ongoing eye on its functionality and safety. If the new information becomes available, update the clinical evaluation and note any adverse events or problems with the product.
- Periodic Safety Update Report: Provide regular updates, particularly for high-risk devices to regulatory bodies. Also ensure compliance with ongoing reporting requirements.
Clinical Evaluation Documentation procedures vary by regulatory framework, so manufacturers must follow EMA or FDA guidelines and stay updated with regulations to maintain compliance with European Medicines Agency (EMA) and US FDA. The demonstration of conformity with Essential Requirements, based on performance evaluation, bench testing, and pre-clinical evaluation, must be substantiated, and presented in a clinical evaluation report.