The International Medical Device Regulators Forum (IMDRF) has released guidelines on clinical evaluations, clinical investigations, and clinical evidence for medical devices. These documents replaced the previous documents that regulated the same areas as issued by the Global Harmonization Task Force on Medical Devices (GHTF).
Clinical Evidence Guidelines
The first document provides a general overview of the most important concepts including clinical evaluation, clinical investigation, clinical evidence and others associated with the process of confirming the compliance of a medical device with applicable requirements on safety, performance and effectiveness. According to the document, clinical evidence is the clinical data together with its evaluation that should be subject to review by regulating authorities or notified bodies during assessment procedures. This information is subject to change during the whole lifetime of a medical device, and should be amended with the new data obtained through use and post-marketing surveillance of medical devices.
The guidance describes the following steps:
- Need for clinical evidence,
- Generation of data through various approaches including clinical examinations,
- Accumulation and structuring of all present clinical data related to the particular issue,
- Clinical evaluation as the process of data analysis and evaluation,
- Finalizing the results of clinical evaluation in the form of an appropriate report that forms clinical evidence,
- Implementation of clinical evidence where applicable (e.g. in technical documentation provided with a medical device).
The document is intended to provide all parties involved with better understanding of all important concepts. The IMDRF notes that this could also result in improvement of the way the resources are used.
Clinical Evaluations Guidelines
According to the definition provided in the Guideline, clinical evaluation is a set of activities based on the utilization of scientific methods for the purpose of clinical data assessment and analysis that is necessary to ensure the safety, performance and actual effectiveness of the medical device. Clinical evaluations should be completed to ensure compliance with the safety requirements when the devices are being used in accordance with the instructions provided by the manufacturer and for the intended purpose. Clinical evaluation should take place at each step of development of a medical device, repeated periodically over the course of obtaining new information from patients and healthcare professionals using the medical devices. The information received as a result of these evaluations should be implemented into existing risk management processes.
Clinical evaluations are intended to confirm:
- Compliance with the Essential Principles of Safety and Performance of Medical Devices;
- Effectiveness of the medical device when used according to the information provided by the manufacturer through labelling and instructions for use;
- Minimization of all foreseeable risks associated with the use of the medical device for the intended purpose; and
- Any other claims made by the manufacturer of the medical device regarding its safety, performance and effectiveness.
The Essential Principles of Safety and Performance of Medical Devices (Essential Principles) constitute a set of principles medical device manufacturers must comply with when designing and manufacturing devices. The harmonized Essential Principles provided by the IMDRF in the form of the appropriate guidance are intended to be used by regulating authorities, notified bodies and any other parties involved for the purpose of the improvement of safety of medical devices.
The guidelines also describe the process of clinical evaluation that includes the following steps:
- Identify the applicable Essential Principles;
- Analyze all the data currently available, including the data on safety, clinical performance and effectiveness;
- Generate the remaining part of data necessary to cover the full scope of issues;
- Analyze all of the data in general.
A report formed as a result of clinical evaluation can be used for further operations with the medical device. For example, it could be submitted to the notified body to provide reliable information on the features of a medical device.
The guidance provides detailed information on general principles of clinical evaluations, identification of clinical data suitable for clinical evaluation, analysis of clinical data, and requirements applicable to clinical evaluation report.
Clinical Investigations Guidelines
The third document issued by the IMDRF describes all the aspects related to medical device clinical investigation. This is defined as systematic investigation in or on one or more human subjects concluded for the purpose of safety assessment. The third document also goes into detail on the spheres of analyzing the performance and effectiveness of a medical device. Clinical investigation should be undertaken in compliance with both scientific principles of data collection and also with ethical standards associated with the participation of human subjects. It is important to mention that In Vitro Diagnostic medical devices fall outside the scope of the guidance.
According to the document, clinical investigation should only take place in cases when there is no other way to obtain the data necessary to confirm compliance with safety, performance and effectiveness requirements from other sources. As usual, this approach is applicable for medical devices that are entirely new or for ones associated with high risk. The document provides special algorithms allowing to identify whether clinical investigations are necessary or not depending on the sufficiency of the clinical evidence present to confirm the compliance with applicable requirements.
In accordance with the main principles of clinical investigations they should:
- Comply with all applicable requirements;
- Be carried out in accordance with applicable risk management procedures to minimize risk;
- Comply with ethical principles;
- Be held on the basis of present results of clinical evaluation;
- Be appropriately planned, conducted, analyzed and reported.
It is also important to consider aspects like minimization of bias that could impact the accuracy and reliability of the results obtained, clarification of objectives of each study and more.
The document also states the requirements that apply to the design of clinical investigations, including multi-regional ones, and to the reporting on the results of clinical investigations and adverse events identified during the investigative process. According to the document, it is necessary to find a balance between the protection of human subjects and the protection of public health requiring clinical investigations to be held to identify possible issues related to use of new medical devices.
The information provided in guidelines issued by the IMDRF is important for medical device manufacturers since it allows a data collection process to be developed. This information also enables manufacturers to obtain the data necessary to confirm the compliance of a medical device with all applicable requirements in a proper way. The data used as a basis for clinical evidence should be collected in a way that reduces the possibility of incorrect results and mistakes to ensure the accuracy and reliability of clinical evidence. Using these guidelines medical device manufacturers will be able to carry on the clinical investigations in a way that minimizes risk for human subjects participating in such investigations.
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