Not every piece of software used in healthcare is a medical device. What decides it is the intended purpose the manufacturer gives it: in the labelling, the instructions for use, the promotional material and the claims on the website. Two products with almost the same code can land on opposite sides of the line because one promises to help diagnose a condition and the other promises to help you sleep.
Getting the answer early matters. If the software is a medical device, it needs a class, a conformity assessment route and technical documentation, and in most cases a notified body. Each of those shapes the budget and the launch date.
The guidance you will be measured against
The Medical Device Coordination Group’s MDCG 2019-11 is the reference text for qualifying and classifying software under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It was revised in June 2025 (rev.1). Notified bodies and competent authorities read your qualification rationale against it, so it is worth following its logic rather than building your own.
The test, in order
Is it software? For the guidance, software is a set of instructions that processes input data and creates output data. Almost everything passes this step.
Is it part of another device? Software that drives or influences the use of a hardware device, without a medical purpose of its own, goes through that device’s regulatory process. An accessory to a medical device is regulated in its own right. A product on MDR Annex XVI (products without an intended medical purpose) follows that route.
Does it do more than store, archive, communicate, search simply or compress without loss? Software that only moves or keeps data is not a medical device on that account. Email, messaging, back-up and plain record retrieval do not qualify. Once the software calculates, interprets, flags, prioritises or changes how data is shown for a medical purpose, it may qualify. A change in how data is displayed that is only cosmetic or for compatibility does not, by itself, make it a device.
Is the action for the benefit of an individual patient? Software that only aggregates population data, offers generic care pathways, gives access to literature, atlases or templates, or serves epidemiological studies and registers is not acting for an individual patient.
Does the intended purpose match the definition of a medical device? That is, diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, or the other purposes listed in MDR Article 2(1). Software for general purposes, even used in a hospital, and software for lifestyle and well-being purposes is not a medical device (MDR recital 19).
Medical device or IVD?
If the software gives information within the scope of the IVD definition, check where its data comes from. If the information is based only on data from in vitro diagnostic devices, it is IVD software under the IVDR. If it combines IVD data with data from other medical devices, weigh which sources drive the intended purpose: mostly IVD data points to the IVDR, mostly device data to the MDR.
Software that uses AI
The qualification test is the same whether or not the software uses machine learning. What changes is what follows. A device that is, or contains, an AI system and needs a notified body under the MDR or IVDR is treated as high-risk under Regulation (EU) 2024/1689 (the AI Act), which adds its own requirements. MDCG 2025-6 (June 2025), a set of questions and answers on how the two regimes fit together, is the place to start.
Also pending: the Commission’s December 2025 proposal to amend the MDR and IVDR (COM(2025) 1023) would revise several classification rules. It is a proposal, not law.
What it means for your product
Write the intended purpose before you write the code, and write it as narrowly as is true. Then test every claim on the website, in the app store listing and in sales material against it, because an authority will read those too. If the answer is “yes, it is a device”, the next question is the class, and for software that means Rule 11. If the answer is “no”, keep the reasoning on file: it is the first thing you will be asked for when someone disagrees.
We write qualification and classification reports for software, including software as a medical device: Qualification and classification.
Related briefing: How is software classified under the MDR? Rule 11 and MDCG 2019-11