Clinical Evaluation & Investigation of Medical Devices

Clinical Evaluation Report Writers Team

What is a Clinical Evaluation?

Clinical Evaluation is a continuous process of generating, collecting, analyzing, and evaluating clinical data regarding medical devices under assessment in order to demonstrate conformance with general safety and performance requirements as per the manufacturer’s intended use. Clinical evaluation is a continuous procedure that begins at the development stage and continues throughout the life cycle of medical devices.

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What is a Clinical Investigation?

Clinical Investigation is a systematic study performed in humans to access the safety and performance of medical devices based on the comprehensive analysis of available preclinical, Clinical (Safety), and post-market data relevant to the intended purpose of the device.

What are Clinical Trials?

Clinical trials are scientific investigations carried out to determine the performance, safety, and potential hazards of using a medical devices on humans. Clinical trials generate high-quality data that may be used to make healthcare decisions. Clinical trials are the last stage of the research and development process before it is tested on people.

Clinical Evaluation and Manufacturers Challenges

Here are a few challenges and that we have heard from the medical device manufacturers!

1. Through understanding of MDR and Guidance documents

MEDDEV 2.7.1 Rev.4 and 2017/745 article 61

2. Clinical Evaluator

Identify a Clinical Evaluator who must have training and experience in the device under evaluation.

3. Interpretation of Preclinical Data

The preclinical testing data  to determine the performance and safety based on the benchmark values

4. State of the Art

As per 2017/745, the clinical evaluation report must demonstrate the state-of-the-art thorough analysis of various parameters and technologies used for similar devices across the globe.

5. Equivalent Device

Devices with the same intended use, same technological characteristics, and biological aspects are considered as the equivalent device

6. Scientific Literature Search

Scientific literature is a permanent record of collective achievements based on the study, and it is the primary medium for communicating the findings of scientific research.

7. Sufficient Clinical Data Collection.

Sufficient clinical data are described as data relating to safety, performance, and side effects in medical equipment in the way they are intended to be used from human clinical studies for the topic, basic devices, or equivalent technology.

8. Technical Documentation

Technical documentation covers clinical evaluation reports in 2017/745 and has been connected through the conformity procedure.

9. Post Market Data

Post-market activities are essential for generating clinical data about the medical devices, which can help discover uncommon occurrences and accidents that were previously unknown.

Clinical Evaluation Process Under EU MDR!

Today we will share the clinical evaluation process under the European medical device regulation EU MDR. We will begin by outlining the regulatory background process and defining key terminologies.

The clinical evaluation process is an important part of conformity assessment for all medical devices, regardless of which risk classification they fall under. It is also closely linked to the risk management process and post-market surveillance activities. This page will clarify and emphasize these parallels throughout each step of the process.

Let’s begin by clarifying the regulatory background and key terminologies for medical device regulations, and other documents, all of which manufacturers must take into account throughout the clinical evaluation process. As per the medical device regulation, MDR clinical data refers to any data about the safety and performance of a medical devices and can be obtained from multiple sources.

The most powerful and determining sources of data are derived from well-designed clinical investigations of the device in question. However, before beginning to plan such an investigation, manufacturers must first identify any current existing data that may be relevant to determining the safety and performance of the device.

Scientific Literature Search & Risk Analysis

Clinical investigations reported in the scientific literature of a similar device. These similarities will be discussed in detail later on, published scientific literature from other clinical experiences or usages, indications of the device in question, or a relevant similar device.

Once a device is on market data from the post-market surveillance activities, particularly post-market, clinical follow-up efforts must also be included in the clinical evaluation report.

Before jumping into the first step of the clinical evaluation process, creating a plan, let’s review some important prerequisites. Before a clinical evaluation can begin, several essential prerequisites must be met.

The intended use must be clearly defined in terms of the target patient population, a thorough risk assessment must be conducted to define safety claims resulting from a full benefit-risk analysis of the medical device within the defined intended use.

EU 2017/745 CER Conclusion

A CER is the evaluated clinical data gathered either through your device’s clinical examination or from other research on equivalent devices considerably. Read more>>

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