Intended use and Indications of use of Medical Device

Intended Use and Indications of Use of Medical Device

Intended use of a medical device defines the purpose for which the device is used. In the CE marking as well as in the FDA pre-market approval or notification, intended use is critical as it helps to decide the classification of a medical device or even for the qualification as a medical device. Intended Use is generally the what the manufacturer label claims for what the medical device is used for.

Indication of Use generally describes the reasons or the situations or the diseases for which the medical device is used to fulfill its intended use. It also gives the more detail on the part of the body where it is used which can also be part of the intended purpose. Hence indication of use also affects the classification of the medical device.

Sometimes the intended use and Indications of use of a medical device are same. Is it possible? How the intended use of the medical device can be decided that has both the medical device and medicinal effect so that it can regulated under the MDR or MDD?
What is the borderline classification guidelines that helps in the above?
What is its role in the CE marking Technical File and clinical evaluation?