Intended Patient Population

Intended Patient Population is the patient’s group on which the medical device is applied. He will be benefited from the device. Sometimes he will be the intended user of the device, i.e he himself can apply the device. For the devices which doesn’t require a specific training to use. For example, A disposable mask.

Intended Users of the medical device is the person who is using the device. He may or may not be benefited from the product. For example, if an implant is applied on a patient by the Healthcare professional who is applying this device is the intended user of the device. The intended users may be a trained or the untrained user. Hence for complicated or more risk devices manufacturer may have the Instructions for use that can be used for the healthcare professional as separate.

What is the relevance of intended user and intended patient population in the CE marking? What is the target population and any difference or similarity to above mentioned group?