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Prior to regulatory approval in the European Union (EU) and other jurisdictions, manufacturers of certain medical devices must conduct a clinical investigation to thoroughly assess the safety and/or clinical performance of their products. Clinical investigations are designed to collect data and information not readily available in scientific literature or from prior pre-clinical testing that can be used as evidence to substantiate a manufacturer’s claims of the safety and/or performance of a given device. Data collected through a clinical investigation can be an essential element of the clinical evaluation report prepared in connection with an application for conformity assessment of the device.
The proper design of a clinical investigation plan is essential for medical device manufacturers, since poorly designed plans can result in data that fail to sufficiently support a manufacturer’s safety and/or performance claims. In some case, a clinical investigation plan fails to identify rules and procedures for the collection of data. In other instances, the sample size identified in the plan is not based on scientific and statistical principles but solely on a manufacturer’s experience. In other cases, the investigation plan fails to select a study protocol that minimises sample bias. These and other flaws in the design of a clinical investigation plan can impede the regulatory approval process and delay market access.
At a minimum, a clinical investigation must follow a proper risk management process to identify all possible risks associated with a medical device, and be appropriately designed to collect clinical data relevant to the safety and performance of the device. ISO 14155, Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice, provides detailed information regarding clinical investigation principles, the process of conducting a clinical investigation, and the information to be collected. A clinical investigation plan designed to comply with the requirements of this standard helps to ensure the collection of objective and credible scientific data, and supports the overall goal of protecting the safety and well-being of patients.
TÜV SÜD Product Service experts can conduct a voluntary pre-assessment of a medical device manufacturer’s clinical investigation plan in advance of execution. In addition, TÜV SÜD Product Service has a global staff of medical device specialists, with over 400 international experts located in major markets around the world. These specialists are supported by the in-house Clinical Centre of Excellence and the scientific advisory board that is under the standard TÜV SÜD confidentiality agreement. This board comprise well-recognised European scientists and physicians from the leading universities and healthcare centres.
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