Clinical data is the information about the safety and performance from the use of a medical device on human beings. For the CE marking of the medical device, it is necessary to demonstrate the clinical safety and performance by the analysis of this clinical data. The clinical evaluation is the systematic process of planning, collecting the clinical data, appraising and analyzing the same.
The clinical data generated with the clinical evidence is acquired through two routes. One is through the clinical investigations performed on human beings with the respective medical device. The other is the literature route in which the literature with the clinical evidence of the studies conducted on human beings with the equivalent devices is acquired. In the second case, we need to demonstrate the equivalence with the comparable medical device with our respective medical device.
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Is it mandatory to perform the clinical evaluation for all medical devices for the CE marking? Is it possible to use both the clinical investigation and literature routes for the clinical evaluation of a medical device? How can we determine what are information on safety and performance as the clinical data?
Yes, The clinical evaluation is mandatory for initial CE marking for all medical devices and it must be updated thereafter. For CE marking it is important to demonstrate the clinical safety and the performance of the medical device by analysis of clinical data.
Yes, it is possible to use both the clinical investigation and literature routes for clinical evaluation of medical device. Clinical data may be collected through the clinical investigation. The second possibility may be the demonstration of safety and performance based on data already publicly available. This data published in scientific literature or data for relevant / comparable device through the literature route. In some cases, both routes might have to be followed to demonstrate clinical safety and performance of a medical device.
We can determine what are the information on safety and performance data by establishing the compliance with General Safety and Performance Requirements (GSPR) applicable for a particular device.
The clinical evaluation is mandatory for CE marking of all medical devices. It ensures the safety and performance of medical device to be introduced into the European market.
The main objective of clinical evaluation is demonstration of the safety and performance of a medical device when it is used as intended. This can be proved either by clinical investigation of the device or by demonstration of the safety and performance by using scientific literature of similar devices already available. If there are any gaps related to the safety and performance which cannot be demonstrated by one of the above routes, we can use a combination of both the above routes.
The general safety and performance requirements given in Annex I of MDR can be used to determine the clinical data related to the safety and performance of the device. According to it, the following requirements should be satisfied: general requirements ( whether the device is suitable for its intended purpose, risks posed by the device, undesirable side-effects), requirements regarding design and manufacture(physical, chemical , biological properties, sterility, incorporation of medicinal substance, construction, interaction with the environment, measuring function, whether it is active device, programmable and can be used by lay person ), requirements regarding the information supplied with the device(label and IFU).