It is extremely important for you to know whether you need to perform bench, animal or human trials on your product. Should your product require human trials, it is extremely important for you to define the sample size of the trials. You need to obtain this information as early in the development as possible.
Not all products require human clinical trials to be approved. This requirement depends on the product classification. Class I products, both in Europe and the USA, do not require animal or human testing. These products need only to go through the formal procedure of medical device listing. Examples: gloves, syringes, bandages, etc. As for class II products (most medical devices belong to this class), the type of testing varies considerably, depending on the technological features of the device, and on its clinical claims. Some class II devices have to be bench-tested, namely, they have to go through laboratory-level testing, to assure safety and technological performance. Example: infusion pumps. Other products of the class II type have to be more rigorously tested. These are products whose safety and effectiveness need to be demonstrated on human subjects. Examples: pain relieving TENS devices, cardiac mapping catheters, etc. All class III products have to be tested on human patients. These products offer a novel technology, and/or new clinical claims. It is the developer’s onus to present clear and unequivocal clinical data on humans, demonstrating the safety and effectiveness of his device.


What type of testing does your product require?

The answer to this important question is part of the regulatory survey, provided by the Arazy Group. In this survey you will receive valuable information regarding not only the classification of your device, but also whether your product requires testing, and if so, what type of testing – bench or human.
Should your product be shown to require human clinical trials, the regulatory survey will also provide you with more specific information regarding the extent of those trials. It should be stressed that the term “human clinical trials” is rather flexible. Some medical products are potentially highly risky, and therefore require extensive trials on many patients. Others, on the other hand, need to be tested on a much more limited number of patients.