Diagnostics: Purpose of my service
Please note that the results correspond to the answers you have ticked. They provide an insight but cannot replace the personalised and in-depth analysis that a legal or regulatory expert can provide.
Does your product have a medical purpose, namely a therapeutic or diagnostic purpose or compensation for a handicap?
As a reminder:
The purpose of this question is to determine whether your product falls within the definition of a medical device.
The definition of a medical device is very broad: mobile applications, heart implants or wheelchairs. It is not the form that matters, but the purpose of the product.
To qualify as a medical device or IVD (in vitro diagnostic), software must meet all of the following criteria :
- It must be intended to be used for medical purposes, as a medical device or IVD device. It must, for example,make or aid a diagnosis, treat or be an aid to treatment ;
- Provide a specific and personalized result for the benefit of a individual patient ;
- Process input data, such as an analysis to provide new medical information. For example, it may be an application that processes and analyses patient-specific physiological signal data and provides alerting functions for medical purposes. This action must be distinct from the storage of data without processing, communication or simple retrieval, such as a database or digital library that aggregates data for the sole purpose of archiving without data.
To better understand: some examples of digital services that are medical devices and some examples of health software and applications Medical Device or not.
Regulations:
Consult the European regulations
Practical guide
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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.