Clinical Evaluation process is an important aspect of MDR 2017/745 as it ensures the device under evaluation’s safety and performance. As per MDR it is expected from the manufacturer to define and justify the sufficient level of clinical evidence necessary for the device under evaluation to show compliance for relevant General Safety and Performance Requirements. Clinical evidence can be gathered through different paths to support the clinical claims of the device when used as indicated. One of the paths that can be used is equivalent device data if the equivalence can be proven as per the requirements of MDR. Another important path is evidence gathered through clinical investigations which started to take greater role on the life cycle of the medical devices after the introduction of MDR.
If as per the Clinical Evaluation and the requirements of sufficient clinical evidence results with the need of clinical investigation, designing, planning and management should be realized in line with current ISO 14155 standard and the clinical investigation requirements of MDR Chapter 61 Articles 62-82. The most crucial part of clinical investigation is to properly prepare clinical investigation plan (CIP) which ensures correct clinical evidence collection as per the need of the device under evaluation as well as the acceptability of the data created. The design of the investigation should be determined and defined in CIP with prioritized strategy for the gaps encountered through the Clinical Evaluation Report.
Clinical Investigation Plan (CIP) is the document in which the objectives, rationale, the design parameters, the investigation methodology, monitoring, statistical consideration and organization of the clinical investigation are explained in detailed providing adequate justification based on scientific and ethical principles as per MDR 2017/745 and current ISO 14155.
The information that is necessary to include in CIP is clearly defined in the current ISO 14155 standard. One of the important parts of the CIP is the synopsis of the study. This part summarizes the investigation including most crucial information in terms of the design. Inclusion/exclusion criteria, study endpoints, number of the subject are the information that must be added to the synopsis. The information related to the sponsor of the investigation as well as the study team should be a part of the CIP. The investigational device and in case it is a comparative study the comparative device (or method) should be described. A clear benefit/ risk analysis should be performed within CIP not only for the investigational device(s) but also the investigation itself to make sure the risks for the subjects will not be greater than the benefits. Detailed procedures, follow up / visit schedule for the subjects, the endpoints to be collected and further design and methodology information should be part of the Methodology part of the CIP. The adverse event management, statistical plan summary, study monitoring details are other important parts. It should be noted that CIP is a document under the quality management hence all the actions related to traceability of the CIP should be taken. The document number and the revision number should be clearly added to the document.
It is very important to prepare the CIP thoroughly for the success of the clinical investigation as well as the reliability of the data collected.
