Diagnostics: Purpose of my service

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Does your product have a medical purpose, namely a therapeutic or diagnostic purpose or compensation for a handicap?

YES

NO

As a reminder:

This question is asked to determine whether your product falls within the definition of a medical device.

The field of medical devices is very vast: mobile applications, cardiac implants or wheelchairs, it is not the form that counts but the purpose of the product. The field of medical devices is very vast: mobile applications, cardiac implants or wheelchairs, it is not the form that counts but the purpose of the product.

To qualify as a medical device or IVD (in vitro diagnostic) device, the software must meet the following cumulative criteria:
- it must be intended for use for medical purposes within the meaning of the definition of a medical device or IVD medical device. For example, it must allow for a diagnosis, an aid to diagnosis, a treatment or an aid to treatment
- provide a specific result for the benefit of a single patient
- perform an action on the incoming data, such as an analysis to provide new medical information. For example, an application that analyses patient-specific physiological signal data and provides alerting functions for medical purposes would qualify as a medical device. This action must be different from storage, communication, or a simple search such as a database or digital library integrating data for the sole purpose of archiving without exploiting them.

Regulations:

Consult the European regulations

Practical guide

You don't know how to answer, the keys for choosing

You don't know how to answer, the keys for choosing

Not everything used in the medical context is a medical device. A large number of products are not intended to become medical devices, but this does not call into question their quality or their interest.

The elements to take into account to determine if your product is a medical device:

  • The nature of the product (mode of action);
  • The purpose of use: which is or will be described in the technical documentation and the instructions for use or even the labelling;
  • The manufacturer's claims: the way your product is presented in advertisements or commercial presentations. If you claim a medical purpose even if it is not in the package leaflet, your product must comply with the medical device regulations. Note that disclaimers stating "for information purposes only" or other statements such as "this product is not a medical device" have no legal value if medical claims are made.

Is a product used only by doctors in a medical setting a medical device?

Not necessarily, the place of use or the type of user do not enter into the qualification of a medical device.

For example, patient administration software used by health professionals in hospitals is not a medical device because it does not have a diagnostic or therapeutic purpose.

Conversely, a mobile application used by a patient at home can be a medical device.

Does the fact of using health data make my product a medical device?

No, the type of data used is not a relevant criterion to define whether you are a medical device.

The focus should be on the purpose of the product and the way it is used.

For example, patient administration software uses health data, but it merely stores the data and therefore has no diagnostic or therapeutic purpose.

Do serious risks associated with an error in the operation of my product make my product a medical device?

No, if administrative management software mixed patient data, the consequences could be dramatic for patients, however as this software has no medical purpose it does not qualify as a medical device.

The qualification as a medical device and the resulting medical CE marking correspond to a regulatory definition.

Many products in the health field do not fall within this definition, but this does not detract from the quality or interest of these products.

Examples

Software that analyses a mammographic image to detect a tumor and indicate an area of interest to the practitioner is a medical device because it is intended to help diagnose a specific patient by using entry data (the image) to create new medical information (the area suspected of being a tumor).

On the other hand, software that transfers or stores a mammogram in digital format is not a medical device because its purpose is document management and archiving.

A connected bracelet that measures heart rate to adapt the intensity of a sports training session is not a medical device because it does not have a diagnostic purpose.

Conversely, a connected bracelet that performs an electrocardiogram (ECG) to detect atrial fibrillation is a medical device because it has a diagnostic purpose.

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