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Clinical Evaluation Documentation

Clinical Evaluation Documentation according to the Medical Device Regulation (MDR) in the European Union is a detailed and rigorous process that involves gathering, evaluating, and analysing clinical data related to a medical device to guarantee its performance and safety throughout its lifecycle.

Clinical evaluation documentation is a crucial process for medical devices to assess safety, performance, regulatory compliance, CE marking, and product development. The Medical Device Regulation (MDR) in the European Union which came into full effect in May 2021 introduces more stringent requirements for clinical evaluation, ensuring the safety and performance of medical devices throughout their lifecycle.

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Benefits of appointing I3CGLOBAL

The following are the major advantages of appointing consultants and clinical writers for Clinical evaluation documentation as per current MDR

Active Post-Market Oversight: Active post-market oversight is crucial to ensure the safety and efficacy of medical devices. This involves continuous monitoring of devices after they have been approved and are in use. Manufacturers should actively collect data on device performance and report any adverse events. Regulatory authorities can use this data to identify potential safety issues, make necessary changes to device labeling, and, in some cases, recall devices if they pose a significant risk to patients. Active post-market surveillance can enhance consumer trust by demonstrating a commitment to safety and responsiveness.

High-Quality Clinical Evaluation Reports (CERs): Clinical Evaluation Reports are essential for demonstrating the safety and performance of medical devices. High-quality CERs are important to avoid regulatory rejections and to ensure that devices remain on the market. They should provide a comprehensive and transparent overview of the available clinical evidence and how it supports the device’s safety and efficacy. Meeting the required standards and guidelines for CERs is crucial to gain notified body approvals and maintain a strong regulatory standing.

Thorough Literature Search Strategy: A thorough, objective, and reproducible literature search strategy is vital for gathering the necessary data and evidence to support a medical device’s safety and efficacy. This strategy should be well-documented and should consider various reputable sources, including peer-reviewed journals, clinical trials, and relevant databases. It should also employ systematic review methodologies to ensure the quality and reliability of the gathered data. A well-executed search strategy is crucial in the scoping stage of CER development.

Faster Turnaround Time for CER Updates: Speed in updating CERs is essential, especially when new data or safety concerns arise. Rapid updates ensure that the clinical evidence for a medical device remains up-to-date and accurately reflects its performance. Delays in updating CERs could lead to regulatory issues or a loss of consumer trust. To expedite CER updates, it’s important to have efficient processes in place, maintain clear documentation, and stay informed about the latest clinical findings and regulatory requirements.

We have an in-house department which takes up Post market Clinical Follow up, Retrospective Study, and Clinical Investigation.

In summary, a combination of active post-market oversight, high-quality CERs, a well-planned literature search strategy, and efficient CER update processes can help ensure the safety and efficacy of medical devices and also to maintain Notified Body CE Certificate validity. It’s important for manufacturers to stay vigilant, responsive, and proactive in managing their devices throughout their lifecycle.

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.