Diagnostics: Is my solution a DM?
Please note that the results shown correspond to the answers you ticked. They provide an initial insight, but in no way replace the personalized, in-depth analysis that a legal or regulatory expert can provide.
Does your product have a medical purpose, i.e. therapeutic, diagnostic or disability compensation?
For the record:
This question is put to you to determine whether your product falls within the definition of a medical device (DM).
The field of medical devices is very broad: mobile application, cardiac implant or wheelchair, it's not the form that counts but the product's purpose of use.
To qualify as a DM or IVD DM (in vitro diagnostics), the software must meet the following cumulative criteria:
- be intended for use for medical purposes within the meaning of the DM or IVD DM definition. It must, for example, enable diagnosis, aid diagnosis, treatment or aid treatment
- give a specific result for the benefit of a single patient
- perform an action on incoming data, such as an analysis to provide new medical information. For example, a patient-specific physiological signal data analysis application with medical alert functions would qualify as a DM. This action must be different from storage, communication, or simple research such as a database or digital library integrating data for the exclusive purpose of archiving without exploiting them.
- Some examples of healthcare software and applications DM ou pas DM
Regulations:
Consultez le European regulation
Practical guide
You don't know how to answer, the keys to choosing
You don't know how to answer: the keys to choosing
Not everything we use in the medical context is a medical device. A large number of products are not intended to become DMs, but this does not call into question their quality or interest.
The elements to be taken into account to determine whether your product is a medical device:
- The nature of the product (modality of action);
- The purpose of use: that which is or will be described in the technical documentation and instructions for use or even the labeling;
- The manufacturer's claims: the way your product is presented in advertising or commercial presentations. If you claim a medical purpose, even if it's not in the instructions, your product must comply with DM regulations. Please 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 environment a DM?
Not necessarily, the place of use or the type of user do not enter into the qualification of a medical device.
For example, patient administrative management software used by healthcare professionals in hospitals is not a medical device because it has no diagnostic or therapeutic purpose.
A contrario, a mobile application used by a patient at home can be a DM.
.Does using health data make my product a DM?
No, the type of data used is not a relevant criterion for defining whether you're a DM.
You have to focus on the product's purpose of use and how it acts.
For example, patient administrative management software uses health data but it merely stores the data it therefore has no diagnostic or therapeutic purpose.
Do serious risks associated with a malfunction of my product make it a DM?
No, if administrative management software mixed patient data, the consequences could be dramatic for patients, nevertheless as this software has no medical purpose it does not qualify as a medical device.
The qualification of DM and the medical CE marking that follows correspond to a regulatory definition.
Many products in the healthcare field do not fall within this definition, this in no way detracts from the quality or interest of these products.
Examples
Software that analyzes a mammographic print to detect a tumor and indicate an area of interest to the practitioner is a DM because its purpose is to aid diagnosis for a specific patient by using an input data (the print) to create new medical information (the area suspected of being a tumor).
A contrario, software that transfers or stores a mammographic print in digital format is not a DM because its purpose is document management and archiving.
A connected bracelet that measures heart rate to adapt the intensity of sports training is not a DM because it has no diagnostic purpose.
A contrario, a connected bracelet that performs an electrocardiogram (ECG) to detect atrial fibrillation is a medical device because it has a diagnostic purpose.