Whether your software is considered as a medical device under the EU MDR is a key thing to determine as the wrong decision can have serious legal and financial consequences for your company.
On one hand, according to the EU MDR, software in its own right, when intended to be used for one or more medical purposes, qualifies as a medical device. On the other hand, software for general purposes, even when used in a healthcare setting or for lifestyle and wellbeing purposes, is not considered as a medical device. Everything depends on its Intended Use.
However, very often, especially for new technologies, classifying software as a medical or non-medical device can cause confusion and may be tricky to figure out.
To understand the rules better, below you’ll find a comprehensive list of the criteria followed by a few real-life examples.
Guidelines to determine whether your software is a medical device or not
Software is a medical device if:
- is explicitly named as one in the EU MDR
- controls or influences a medical device
- serves the “post-processing” (e.g. for an ECG) or data preparation
- calculates output signals or output values
- serves the support of diagnostic or therapy
- serves the “objective” diagnosis or treatment
Software is not a medical device if:
- is used for administrative purposes (e.g. managing patient data)
- is used for training doctors (e.g. training software with medical knowledge)
- is used for general maintenance of medical devices or their components (however, sometimes can be treated as a medical device accessory)
- is used for development or production tools (however, such must be validated)
- represents a proprietary operating system
Let’s now take a look at how it looks like in practice.
Examples of qualifying software as a medical device
#1 Hospital Information Systems
Hospital information systems support the process of patient management: from patient admission, through scheduling appointments, to insurance and billing purposes.
According to the EU MDR, such Hospital Information Systems aren’t qualified as medical devices. However, they may be integrated with additional modules, which in turn can be classified as medical devices in their own right.
For example, a Roentgen device may automatically send a patient’s medical results to the Hospital Information System, where it’s available for the medical staff and the patient. In this case, the Roentgen module is classified as a medical device, while the Hospital Information System itself isn’t. That’s why it’s so important to be able to tell the difference between what is and what is not classified as a medical device according to the EU MDR rules. Especially so, that the risk or any kind of corner cases and integration failures, etc., always rests with a medical module.
#2 Decision Support Software
Decision Support Software usually combines general medical information databases and algorithms with patient-specific data. Such tools are intended to provide healthcare professionals and users with recommendations for diagnosis, prognosis, monitoring and treatment of individual patients, thus they are classified as medical devices.
An example of decision support software are radiotherapy treatment planning systems that are intended to calculate the dosage of ionising radiation to be applied to a specific patient. Since they control, monitor and directly influence the source of ionising radiation, with the new MDR regulation they are classified as medical devices.
A similar example are drug planning systems used in chemotherapy, which are intended to calculate the drug dosage to be administered to a specific patient. They are classified as medical devices too.
Another example of decision support software considered to be medical devices are Computer-aided Detection Systems that are intended to provide information, which may suggest or exclude medical conditions, for example by automatically analysing x-ray images or interpret ECGs.
#3 Electronic Patient Record System
Electronic patient record systems are intended to store, archive and transfer electronic patient records. For example, an electronic patient record that simply replaces a patient’s paper file does not meet the definition of a medical device. As long as these systems aren’t used for analysis or decision making based on the data stored, they are not qualified as medical devices.
However, modules such as an image viewer that can be used for diagnosis based on digital images used with an electronic patient record system might be qualified as a medical device.
#4 Telemedicine systems
A communication system, usually based on software for general purposes, that is intended for general purposes and can be used for transferring both medical and non-medical information does not fall under the definition of a medical device, as long as it’s not used for diagnosing.
However, other modules used with such a communication system might be qualified in their own right as medical devices. These are for example:
- Telemedicine systems – that are intended to allow monitoring and delivery of healthcare remotely.
- Telesurgery – that is intended to conduct a surgical procedure remotely. Virtual reality technology may be used to support a remote surgeon to control a surgical robot performing a surgical procedure.
#5 Web systems for data monitoring
A web system for the monitoring of clinical data typically interacts with a medical device (e.g. implanted devices or homecare devices) and uses a transmitter to send the information over the internet, a landline telephone or a mobile network.
The information is collected and stored on a web server usually run by an external party who is the general manufacturer of the system. Authorised health professionals and patients can get access to the information through the Internet connection.
However, for example, modules intended to monitor the performance of medical devices that are connected to such a web system are qualified as medical devices according to the MDR. Such modules can also monitor the clinical performance and failures that could affect the medical performance of the device. Such products include, for example, web systems for the monitoring of active implants or Intra Cardiac Defibrillators (ICDs).
Yet, modules intended to perform administrative monitoring of the non-medical performance of medical devices do not fall under the medical device definition according to the MDR. This also applies to software for monitoring medical devices for the purpose of maintenance and repair.
#6 Home care monitoring (wired or mobile)
Software intended for archiving patient’s medical results or for transferring results obtained from medical devices used in a home environment to the healthcare provider is not a medical device because the results are available, readable and understandable by the user without the intervention of the software.
Does your software qualify as a medical device?
To figure out the answer to this question you should first define the intended use of your product and check if it matches the definition of a medical device according to the MDR. As the next step, you should check Annex XVI of the EU MDR and see if your product matches any of the definitions included there.
If you’re not sure how to interpret the definitions in relation to your product, we can help you. Contact us using the contact form below and we’ll get back to you as soon as possible.