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Software as a Medical Device MDSW in the MDR and its CE Marking. CE Marketing Strategies
One of the aspects that the Regulation (EU) 745/2017 or MDR has clarified and specified in relation to Directive 93/42/CE is related to software as a medical device. Already in the very definition of a medical device, it is stated that: A Medical Device is a software intended by the manufacturer to be used in humans, separately or in combination for diagnostic, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease, injury, or disability, for the investigation of a physiological or pathological process or state, or to obtain information through in vitro examination of specimens derived from the human body.

Therefore, if the software we are developing is intended for what is stated in this definition, it is, in principle, a Medical Device. In principle because it is not the only requirement that the sw must meet to be considered a Medical Device, an MDSW. The MDCG 2019-11 guide indicates the requirements for software to be considered an MDSW.

Another condition it must meet is that it is software, meaning it is a set of instructions that processes input data and creates output data. The input data are those provided to the software to obtain output data after their calculation or processing. For example, data provided through voice recognition, received from other devices, or transmitted by other devices, or provided through an optical pen, a touchscreen, or a mouse.

The output data are all those produced by the SW after processing, such as those displayed on a screen (images, characters, graphics, etc.), DICOM files, a pdf, or a jpeg image.

For it to be considered an MDSW, it is necessary that this processing has some weight, meaning it is not a sw that only stores, transmits data, archives, or performs a simple search.

In short, software intended to process, analyze, create, or modify medical information can be classified as Medical Device Software (MDSW) as long as the creation or modification of that information has an intended medical purpose. For example, software that enhances the contrast of a medical image to determine a diagnosis or therapy.

The MDSW is software independent of hardware and has its own medical purpose. The manufacturer of an MDSW must obtain the CE Marking to market it in the European Union.

However, there is a type of medical software that drives or influences a medical device. In this case, it will be considered either an additional component of the medical device hardware or an accessory of it.
The sw that drives or influences the Medical Device
It is software intended to drive or influence the use of a medical device (hardware) and does not have nor perform a medical purpose by itself, nor create information by itself for one or more of the medical purposes described in the definition of a medical device. This software can, but is not limited to:
operate, modify the state, or control the device, either through an interface (e.g., software, hardware) or through the operator of this device provide output related to the operation (hardware) of that device
To market this software, the manufacturer must determine if it is considered a component of the medical product itself (hardware) in which case the CE Marking of the hardware will include the software, or if it is considered an accessory of the medical product hardware in which case, it will have its own CE Marking complying with the MDR requirements.

Marketing strategy of an MDSW that acts together with hardware or hardware component.
An MDSW must comply with the MDR on its own right, which means that to be marketed in the European Union it must have the CE Marking demonstrating that it meets the general safety and performance requirements and all the requirements specified in the reference Regulation.

But, what happens when we have sw that is an MDSW and acts together with a medical product or component of a medical product? That is, the MDSW has CE Marking on its own. The MDCG 2023-4 guide explains certain concepts.
Marketing strategies of an MDSW that works together with a medical product
The marketing strategies of these products can be varied. Let’s give some examples:
a device that has a sensor that transmits data to a platform considered MDSW A hardware component incorporated into a smartphone or Tablet connected to an application considered an MDSW on another smartphone or Tablet (wearables)
In both cases, two scenarios may occur:
The manufacturer of the sensor and the MDSW are the same entity or different entities The manufacturer of the wearable and the MDSW application are the same entity or different entities
The CE marketing strategies of these products composed of MD hardware and MDSW are two:
Market the hardware or hardware component as an accessory of the MDSW: in this case, both hardware and software products must have their own CE Marking, which means that regardless of whether they are manufactured by the same company or different ones, both must comply with the MDR requirements to place them on the market. Market the hardware or hardware component as a medical product considering it as part of a system (hardware + MDSW) or as a component of a medical product that is the MDSW. If we consider the marketing as a system, the hardware must comply with the applicable legislation and will carry or not CE Marking depending on the intended use given to it, and the MDSW will have its CE Marking as a medical product. If it is considered that the hardware is a component of the MDSW product, the CE Marking of the product will include the hardware.
Nevertheless, in any case, MDSW manufacturers must demonstrate compliance with the MDR, that is, they must verify, validate and demonstrate the safety, reproducibility, compatibility, and interoperability of the medical product or accessory of a medical product with which the MDSW works in combination, including all the various configurations and variants.

Likewise, the clinical evaluation of the MDSW must be considered taking into account the intended medical purpose achieved in combination with the medical product or the accessory of a medical product with which it works.

deviCE Sistemas can help you achieve the CE Marking of your MDSW.