What Is a Clinical Investigation?
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If you’re a part of the medical device industry, you must be familiar with the terms “clinical investigation,” and “clinical evaluation.” There is a possibility of confusion between the two, as they both seem to have similar meanings; however, they are entirely different, and it’s important to understand the difference between them.
In this article, we’ll discuss what a clinical investigation is, how it’s different from a clinical evaluation, and when it is needed.
What Does a Clinical Evaluation Entail?
A clinical evaluation is an assessment of a medical device’s safety and performance. It’s conducted by reviewing the data from different sources, such as scientific literature, similar devices already on the market, clinical studies, and user feedback. The purpose of a clinical evaluation is to determine whether a device is safe and effective for its intended use. Once the clinical evaluation is complete, the findings are used to make changes to the device or its labeling, if necessary.
A clinical evaluation is required for all new medical devices before they can be marketed in Europe. For those in the US and wondering if the FDA requires a clinical evaluation report, check out our recent article.
The European Union Medical Device Regulation (MDR) defines a clinical evaluation as “a systematic and planned process to continuously generate, collect, analyze, and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.”
The findings of a clinical evaluation are submitted as a clinical evaluation report (CER), which is a document that contains all the data and information collected during the evaluation process. Medical device companies must comply with MDR regulations and can do so by adhering to the best practices laid out in MEDDEV 2.7.1, the latest guidance document on the topic, when creating CERs and writing literature reviews for clinical research.
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What Is a Clinical Investigation?
A clinical investigation is a study that is conducted to generate and collect clinical data about the safety, efficacy and performance of a medical device. This data is then used to support the clinical evaluation of the device.
Clinical investigations are typically conducted on new medical devices which aren’t similar to the devices already on the market; they are also conducted on modifications to existing devices, or when there’s a lack of data from other sources that can be used for the clinical evaluation.
Clinical investigations are regulated by the European Union Clinical Trials Directive, which defines them as “any study in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational medicinal product(s), and/or to identify any adverse reactions to an investigational medicinal product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational medicinal product(s) with the object of ascertaining its safety and/or efficacy.”
The directive also outlines the requirements for conducting clinical investigations, such as obtaining ethical approval and informed consent from study participants. Clinical investigations are conducted according to a study protocol, which is a document that outlines the objectives, methods, and procedures of the investigation. The findings are submitted as a clinical investigation report (CIR), which is similar to a CER.
The main difference between a clinical investigation and clinical evaluation is that unlike a clinical evaluation, a clinical investigation is not always required to market a device.
When Is a Clinical Investigation Needed?
A clinical investigation is only needed when there’s a lack of data from other sources that can be used for the clinical evaluation. This includes cases where:
- There are no similar devices already on the market
- The manufacturer is making a new claim about the device
- There have been modifications made to the device
- The device is being marketed to a new sect of users
- There is a novel intended purpose of the device
- The device is being marketed for an increased duration of use
- There are medicinal substances incorporated into the device
A clinical evaluation is required for all new medical devices before they can be marketed in Europe, creating a systematic and planned process of collating available clinical data to verify the safety and performance of the device when used as intended.
A clinical investigation, on the other hand, is a study conducted to generate and collect data about the safety and performance of a medical device when there is a lack of data from other sources. It’s not always needed and is not a mandatory part of the regulatory process.