Medical Software

With growing cross-linking in the healthcare sector and the possibilities of medical simulation in combination with high-performance computing for cloud-based software solutions, medical software is playing an increasingly important role and supports the approach of personalized medicine.

Definition of medical software? Which software solutions belong to the medical software category?

Medical software refers to software solutions that are used in medicine. A distinction is made in medical software between embedded software and stand-alone software. Embedded software is an integral part of an existing medical product. Stand-alone software is itself an independent medical product. The third option is software as an accessory of a medical device.

The first two definitions are not explicitly differentiated in the MDR, but there are implicit differences, e.g. in validation. For stand-alone software, verification and validation of the software are necessary. For medical software that is part of an existing medical device, only verification needs to be performed, as only the entire product needs to be validated.

In 2016, IEC/CD1 82304-1 Health Software – Part 1: General requirements for product safety was published. The standard describes the requirements for product safety (SAFETY), information security (SECURITY), usability (USABILITY) and instructions for use (INSTRUCTION FOR USE). It requires adherence to a software development process and references IEC 62304/A1:2015. IEC 62304 has become the standard for medical device software solution development in both the EU and the US, whether or not the software is standalone.
The following terms are distinguished:

• HEALTH SOFTWARE: Software specifically designed to maintain or improve the health of individuals or to provide care.

• MEDICAL SOFTWARE: Software specifically intended for use in a physical medical device or intended to be a SOFTWARE medical device.

• SOFTWARE MEDICAL DEVICE: Software that is intended to be a stand-alone medical device.

• MEDICAL DEVICE SOFTWARE: Software that is specifically intended to be incorporated into a physical medical device.

What classifications are there for medical software?

Whether software qualifies as a medical device is determined by the manufacturer’s intended purpose for the software. If this corresponds to the definition of the term “medical device” according to Article 2 of the Medical Device Regulation (MDR), the software is designated as a medical device. The functions of the software do not play the decisive role. Article 2 (1) of the MDR defines which products are to be classified as medical devices. For example, an app for analyzing cardiac performance may be intended as a fitness tracker and is therefore not considered a medical device. However, if the app assists a cardiologist with diagnostics, the software is to be evaluated as a medical device.

Only if the medical software is to be classified as a medical device, one has to deal with the risk classification. Here the MDR distinguishes 4 risk classes: I, IIa, IIb and III

Basically, the following statement can be made: The greater the potential harm caused by the use of medical device software, the higher the risk class tends to be.

For example, medical software that supports decisions on a patient’s therapy and diagnostics or monitors physiological processes already falls at least into class IIa. To properly classify medical software, medical software companies should follow Rule 11 of the current MDR.

In summary, the medical software manufacturer must take into account that they are responsible for deciding whether a software is a medical device or not. The responsibility for the classification or correct classification into a risk class also lies with the medical device manufacturer. This must be done very carefully, as in the worst case certification by the notified bodies may be prevented or the medical device may even have to be subsequently withdrawn from the market.

• Helpful support can be found in the Guide to Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR. https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_2019_11_guidance_qualification_classification_software_en.pdf

Additional guidance can be found by medical software companies here: 

• MDCG 2021-24 – Guidance on classification of medical devices https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf

There is currently discussion about an EU AI regulation that could soon become part of the regulatory requirements for medical device manufacturers. This includes medical software developed using machine learning and or logic and knowledge-based/statistical approaches that can produce results for a set of human-determined goals. These may include, for example, predictions, recommendations, or support for specific decision-making processes that affect the environment.

The decision is expected to be adopted in 2022. Medical devices, and medical software in particular, will be classified as high-risk AI in this regard. For these high-risk AI products, requirements increase in the following areas:

• Post-market monitoring and market surveillance.
• Information requirements
• Risk management
• Data requirements, especially training data
• Technical documentation
• Automatic logging
• Human supervision
• Accuracy, robustness and cybersecurity
• Registration of AI in EU databases

It is likely that the decision would thus also have a direct impact on the classification of medical device software.

What are the advantages of Simq’s software solutions? What distinguishes Simq’s medical software solutions?

Simq’s medical software solutions are all developed to the highest standards. Simq is a certified simulation and software manufacturer according to ISO 13485 in the field of medical and medical technology and follows the IEC 62304 standard when developing software, thus meeting the requirements of the EU MDR (Medical Device Regulation) for daily clinical use.

The medical software solutions are developed in close cooperation with universities, physicians and medical device manufacturers.We place particular emphasis on the verification and validation of the medical software, for example by means of elaborate test series or patient studies. 

Depending on the intended purpose, we can also develop software based on our Simq platform that is not classified as a medical device. 

What else should you know about medical software?

From a regulatory perspective, the same requirements are placed on medical software as on a physical medical device. Accordingly, medical software must meet the highest quality standards. Medical software is not to be confused with health apps. Thus, the MDR describes that software for general purposes or from the areas of lifestyle and well-being is not a medical device.

What else should you know about Simq?

Simq is a certified simulation service provider and software manufacturer in the field of medical and medical technology and is one of the pioneers of in silico medicine.

Simq products and services enable medical device manufacturers, physicians and medical staff to practically apply numerical simulation and use it for more effective, safer and personalized patient care.

Simq is committed to the standardization and broader application of in silico medicine through the Avicenna Alliance to ensure safe, affordable and cost-effective healthcare.

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