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Key Differences in US and EU SaMD Regulations

Getting your software as a medical device approved in global markets requires a firm understanding of how these products are regulated in the US and European Union. In this article, we look at the key differences between medical SaMD regulations in the US and EU to help you get to market sooner.

Software and AI are quickly becoming more important in medical technology. To keep up with this trend, regulatory bodies have had to create special regulations to classify and approve new standalone software meant to treat, cure, diagnose, or monitor a medical condition. Between the US and EU, SaMD regulations have some key differences.

In this article, we’ll look at what these differences are and how your company can most effectively meet both agencies’ criteria without wasting time or resources.

What is SaMD?

Most global regulating bodies, including the FDA, define software as a medical device (SaMD) using the definition put forth by the International Medical Device Regulators Forum (IMDRF):

Software as a medical device is any software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.

To be considered SaMD, the software must be used for “medical purposes.” The FDA defines this element as any type of medical technology used to “diagnose, treat, cure, mitigate, or prevent a disease or medical condition.” Software that is meant to support those with medical conditions but doesn’t actively do any of the above is not considered SaMD. This distinction is often easy to see in software meant to work with medical devices but much harder to discern in software meant to work through a smartphone application (also known as a mobile medical device).

Software that is embedded within a medical device is not considered SaMD. In this case, the software is subject to the same regulatory guidelines as the device itself. True SaMD works separately from medical devices, though it often connects to one or more pieces of medical hardware. Most often, SaMD runs on non-medical computing platforms, such as smartphones, tablets, and computers.


While the FDA refers to stand-alone medical software as SaMD, the EU uses the verbiage medical device software (MDSW). This term comes with its own definition:

Software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR).

In general, though, SaMD and MDSW are interchangeable. Most software considered SaMD by the FDA would be considered MDSW by EU regulating bodies.

Differences in US and EU Regulation

Every region has a different governing body that regulates medical software. But the EU and the US are considered the leading regulatory authorities. As such, most countries structure their guidelines based on the rules set by these organizations.

But between these two governing bodies, there are a few key differences that companies should be aware of during the software development process. Understanding the different structures and requirements of these two regions will help you achieve approval in each more quickly.

Who Regulates SaMD

In the USA, the Food and Drug Administration (FDA) is responsible for regulating medical devices, including stand-alone medical software. This organization uses guidelines based on many international standards, including ISO 13485, ISO 14971, and IEC 62304.

SaMD approval in the EU formerly went through the medical device directive (MDD) and active implantable medical device directive (AIMDD) for approval. In 2021 these directives were replaced with medical device regulation (MDR). Medical devices and software used in vitro were formerly regulated by the in vitro diagnostic medical device directive (IVDD). Now it is in vitro diagnostic regulation (IVDR) that plays that role.

Like the FDA, these EU regulatory bodies use many of the same international standards to guide their approval process. Following these ISOs is the simplest way to prepare for submission to both parties. Even still, you’ll find a few key differences in how each classifies SaMD and what the expected time for approval is.

Classification Process

The FDA uses four classes for risk categorization for SaMD: class I, class II, class III, and class IV. Class I represents the lowest risk, while class IV is the highest.

EU risk class categorization is slightly different. They use class I, class IIa, class IIb, and class III. In this categorization, class I is the lowest risk category and class III is the highest with the middle two being medium and medium-high risk, respectively.

The process of determining which class your medical device software will fall into is also different between these two organizations. 

For the FDA, classifications are made by comparing your product to products already in the database. The class of your SaMD is determined by the classification of the most similar applicable product in the database. This makes classifying and gaining approval for new devices fairly straightforward. Where things get complicated is when you cannot find a similar device in the database. Approval for novel SaMD is an extensive process.

For the EU, you must go through a framework of rules to determine the classification of your device. The type of software you are submitting determines the complexity of this process. In vitro SaMD only requires 7 steps. These waterfalling yes or no questions are easy to go through and lead quickly to your classification answer. For other types of software, you must work through the 22 rules needed for standard MDSW classification.

Approval Time

Approval times for SaMD in both the US and EU can vary dramatically based on the device or software submitted. While the self-prescribed classification system the FDA uses often leads to faster approval, this is not always the case. Novel SaMD can take an excruciatingly long time to receive approval. Often, lower classed software gets held up as the agency determines whether or not to enact enforcement discretion. Those that fall into the former category will not need approval to go to market, but it can take time to find out if this is the case.

In the EU, riskier software is often up-classed into a higher category than what was determined by the regulatory rules. When this happens, a Notified Body gets involved. When this happens, approval outcomes often take up to 6 months to complete.

Using Experience to Navigate Regulating Agencies

Designing SaMD in line with international standards from day one of development is one of the best things you can do to set yourself up for the approval process. But getting through the process quickly and without issues requires more than good intentions. You need experience to efficiently navigate the differing landscapes of the US and EU SaMD regulatory process.

One of the things we specialize in here at Sequenex is helping diabetes software companies navigate the complex steps necessary for approval in local and global markets. We have decades of experience bringing medical devices and software through regulation in the FDA, EU, and beyond. 

We can help your company prepare for regulatory success from day one of your software development and handle the approval process so you can focus on making the best SaMD possible. Contact us today for more information and to find out what else we can do to help you get your product to market sooner.

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