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?
The person using the device is intended user of the medical device. The intended users may be trained or untrained; they provide information about the use direction of medical device from manufacturers. The patient category to which the medical device is administrated and benefited from the device is the intended patient population. Some devices are restricted to use only by healthcare professionals and sometimes the intended patient population is the intended user as well because for some devices doesn’t require training to apply, patients can use themselves. Through CE marking, responsibility and sufficient access to information, adequately delivered to the intended user, are important for protecting public health, encouraging patients and healthcare professionals and enabling them to take informed decisions, providing a reasonable foundation for making regulatory decisions and building trust in the regulatory system.
Target population comprises of both Intended patient population and intended User population, that is, the entire population to which the medical device is exposed. Example: For X-ray machine target population will be the healthcare professionals (Radiologist) and patients who are examined.
Identifying the intended users and intended patient population of the medical device is important for technical documentation of medical device and for CE marking. The intended user of the device can be any person who will be operating or handling the device. It can be a healthcare professional or a lay person or a patient himself depending on the instructions given by the manufacturer. The intended patient population are usually the patients with a medical condition to be diagnosed, monitored or treated (or) the persons who will be clinically benefited by using the product.
The performance evaluation of the device for CE marking depends on the response obtained from the intended users and patients. The clinical evaluation should also show the evidence that the device can be used on all target patient population (including disabled persons if applicable) and the device design is adequate for all intended users.
Both patients as well as users of the device are representative of the target population of the device who will be exposed to risk (if any) with the device usage.