Medical Device Software in the EU

by | Oct 24, 2023 | CDRH, Compliance, Digital Health, FDA, Software

Aside from the EU MDR transition, medical device firms that have a software component to their device have another unique set of challenges to tackle. The MDCG published guidance on medical device software (MDSW) this month that is intended to clarify when devices that use MDSW would be considered medical devices themselves, or accessories to medical devices.

Different types of MDSW use a combination of various different hardware components to provide an output, either diagnostic information or even some sort of therapeutic output. Depending on the intended use, the combination of hardware and software can change on how the regulation is applied to the product. This, in turn, can affect the product’s state-of-the-art status, and the level of performance and safety data that must be proven.

The guidance defines two different categories of products: external components that provide data input for MDSW apps, and the second being hardware components that are incorporated with the MDSW. An example of the first category is skin-surface patches, that feed information like body temperature back to the MDSW app. The app then utilizes this information for diagnostic or therapeutic purposes. The second category includes smartphones or wearable fitness tracking devices (like FitBits) that can either act as an output device or have two-way communication with the app. Depending on the intended use of the product, the hardware can either be regulated as a medical device, a combination medical device, or an accessory to a medical device.

If the software/hardware alone cannot achieve the intended medical purpose, then they will not be considered stand alone devices. In this situation, the combination of the software/hardware would be defined as “the device”, so the technical file would need to reflect that. In many cases of wearables, the hardware (such as a FitBit or an Apple Watch) is not considered the device – just the software. However, depending on the intended use, if the hardware is included in the boundary of the device, then it will also need to comply with the general safety and performance requirements (GSPRs).

The most critical piece of this guidance is ensuring that all risks are appropriately mitigated. MDSW products come with a unique set of risks, especially ones that are utilized for “at home” use or by lay people. Even though this guidance does not cover cybersecurity, it highlights that the combination of software/hardware, and any communication risks need to be covered in the product tech file.

EMMA International can help bring your medical device with software components to market in the EU, even devices with AI/ML! Call us at 248-987-4497 or email to learn more!

[1] Medical Device Coordination Group (Oct 2023) MDSW Hardware Combinations retrieved on 10/23/2023 from

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