Medical Device Use & Intended Use

What is the “Intended Use” of a medical device? Intended use is a part of the Normal Use. The intended use includes some Use Errors and the correct use. No manufacturer is required to create a fool-proof product: it does not include Unreasonable or unforeseeable misuse. The correct use includes the generally accepted practice and operation according to the instructions for use. Examples of Unreasonable or unforeseeable misuse are : maintenance error by a service technician (after training), routine inspection error by a service technician (after training), continuously ignore warnings/advices, professional user who disconnect the power from some devices while the device is turned on