SaMD Classification (Software as a Medical Device)

Is my software a medical device?

What decides it is the software's intended purpose, not its technology. Software is a medical device when, on its own, it is intended for a medical purpose such as diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. The MDCG 2019-11 guidance sets out the qualification test.

• Likely a medical device: software that calculates a diagnosis, recommends treatment, interprets images or signals, or monitors a patient to inform clinical decisions.
• Usually not a medical device: software that only stores, archives, communicates or runs a simple search, or that handles general administration, with no medical purpose.
• Modular products: only the modules with a medical purpose are regulated, and they should be identifiable and separable from the non-medical ones.

For a step-by-step walkthrough of this decision, see our guide on how to know if your software is a medical device.

How is SaMD classified? Rule 11 in detail

Once software qualifies as a medical device, Rule 11 assigns its class based on the significance of the information it provides:

• Information used for diagnostic or therapeutic decisions is at least Class IIa. It is Class IIb if a wrong decision could cause serious deterioration of health or a surgical intervention, and Class III if it could cause death or irreversible deterioration of health.
• Information used to monitor physiological processes is Class IIa, rising to Class IIb for vital physiological parameters where a variation could put the patient in immediate danger.
• All other software is Class I.

Rule 11 sits inside the wider Annex VIII framework. See our MDR device classification guide for the full set of rules and risk classes, or compare the available MDR classification tools if you would rather have something work it out with you.

How are AI and machine-learning devices classified?

AI/ML software has no separate MDR class. It is classified through Rule 11 like any other medical device software, according to the clinical decision it informs. AI devices do carry extra expectations, covering training-data quality, clinical evaluation, transparency and post-market performance monitoring, and they increasingly interact with the EU AI Act, which layers its own requirements on high-risk AI systems.

Frequently asked questions

Is my software a medical device under the EU MDR?

Software is a medical device when it has a medical purpose of its own, such as diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. Software that only stores, archives, communicates or runs a simple search, with no medical purpose, is generally not a medical device. What matters is the intended purpose, not the technology (see the MDCG 2019-11 guidance).

How is Software as a Medical Device classified? (Rule 11)

Rule 11 of Annex VIII classifies medical device software. Software that informs diagnostic or therapeutic decisions is at least Class IIa. It is Class IIb if a wrong decision could cause serious deterioration or a surgical intervention, and Class III if it could cause death or irreversible deterioration. Software that monitors physiological processes is Class IIa, or IIb for vital parameters where a variation could cause immediate danger. All other software is Class I.

How are AI and machine-learning medical devices classified?

AI/ML software has no separate MDR class. It is classified through Rule 11 like any other medical device software, based on the clinical decision it informs. AI devices do carry extra expectations around data quality, clinical evaluation, transparency and post-market monitoring, and they increasingly interact with the EU AI Act.

Why did the MDR up-classify so much software?

Under the old MDD, most standalone software was Class I. Rule 11 in the MDR pushes the majority of decision-support and monitoring software to Class IIa or higher, which means Notified Body involvement, deeper technical documentation and stronger clinical evidence for products that used to self-declare.