DE GRUYTER Current Directions in Biomedical Engineering 2021;7(2): 644-647

Tabea Lukas, Keywan Sohrabi, Volker Gross, Michael Scholtes*

Health Software Product or Software as
Medical Device
An Orientation Guide for Young Entrepreneurs

Abstract: The number of software products in the field of to be expected, that the market for apps in this field will
health and medicine increases excessively. Self-tracking, prospectively grow [2].
fitness, health advice, dose calculation, and analysis of In the third quarter of 2020, the Google Play Store contained
physiological data – apps are popular and commonly used. 47,140 mHealth apps (for comparison: Q3 2015 ca. 27,417)
Some of the products are affected by the medical device and the mHealth apps market grew at a rate of 14.3% from
regulation, consciously or unconsciously. For young 2019 to 2020. A rising number of healthcare professionals
entrepreneurs, it is difficult to recognize and understand the recommend mHealth applications and platforms for patient
distinction between software as medical product and health care. [3]
software products. A product-related orientation guide could The scope of apps ranges from self-tracking, through fitness
help start-ups to understand the difference and to find the right and healthcare information to the analysis of physiological
strategy for placing their product on the market. All relevant data or the calculation of drug dosages. There are general
information were collected and analyzed. Input came from a concerns about the quality and the safety of those apps.
systematic literature research, an evaluation of the Additionally, there are uncertainties, whether and when an app
CHARISMHA study and a consideration of the medical is a medical device and thereby the Medical Device Regulation
device regulation as well as the relevant standards (e.g. IEC (MDR) will be applicable [1]. For entrepreneurs, especially for
62304 and IEC 82304). The guide was adapted to the start-ups and unexperienced or small enterprises, it is often
particular situation of start-ups and microenterprises, inter alia unclear which regulatory requirements must be met in detail
having regard to missing regulatory affairs competences. A and what legal consequences arise from the classification as
product-related orientation guide for young entrepreneurs was medical device [2]. Furthermore, the terminology is not
developed, which helps to identify whether products are unambiguous. It is not trivial to understand the difference
affected by the medical device regulation or not. The guide between medical app and health app. Both terms are often used
uses a few simple questions, and it allows the entrepreneurs to synonymously, or distinction is vague [4]. Apps related to the
estimate the related effort. Furthermore, it provides an health care sector are not necessarily medical devices,
overview of relevant standards and needed competences for therefore a clear definition of the terms is very important [2].
the chosen path. The guide brings certainty and can help young The MDR involves substantial changes for the
entrepreneurs to identify the upcoming workload at an early development and distribution of medical devices, including
stage. Due to the decision tree concept, it is easy to adapt the and notably for software and mobile apps as medical device.
product-related strategy and see the consequences. This might Legal manufacturers need to know the regulatory framework
help entrepreneurs to find the right strategy for placing their exactly. [5]
product on the market. Nevertheless, field testing with the In particular, the new classification rule 11 of the MDR
guide is necessary to validate its benefit. Annex VIII states, that software “…intended to provide
information which is used to take decisions with diagnosis or
Keywords: Software as Medical Device, Health App
therapeutic purposes…” must be at least class IIa. If there
might be a serious deterioration of a person's state of health, it
https://doi.org/10.1515/cdbme-2021-2164
must even be class IIb [6]. Combined with the definition of a
medical device (Article 2, MDR), it can be anticipated, that
most medical stand-alone software will be classified as class
1 Introduction IIa or higher.

Software products for smartphones and tablets, so called apps,

are widespread and popular, even in the health sector [1]. It is

Open Access. © 2021 The Author(s), published by De Gruyter. This work is licensed under the Creative Commons Attribution 4.0 International License.

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Health Software Product or Software as Medical Device

1.1 Young Entrepreneurs 3 Results

The overall goals of the MDR (see Preamble 1 and 2) are
among others a positive effect on innovations and a smooth
functioning of the internal market, taking the small- and
3.1 Terminology and scope summary
medium-sized enterprises into account. [6] Software as a Medical Device (SaMD) or Medical
The Neue Zürcher Zeitung and Conceplus estimate, that Device Software (see Fig. 1 A) is defined as stand-alone
due to MDR up to 30,000 additional professionals will be software that meets the definition of a medical device
needed (despite shortage of specialists) and financial damage according to the MDR (Article 2). This means that legal
up to 18 billion Euros. They conclude that small companies manufacturer must comply with the MDR and the
might disappear and that thereby the MDR’s goal was missed applicable standards.
[7]. Hagen and Lauer have published a survey of start-ups that Health Software Products are defined in IEC 82304-1
indicates that 67% of the enterprises consider the duration of chapter 3.6 as: “software intended to be used specifically
the CE-certification process as significant barrier and 66% are for managing, maintaining or improving health of
not well informed regarding the role of the notified body and individual persons, or the delivery of care”. This includes
the conformity assessment procedure [8]. but is not limited to SaMDs (see Fig. 1 A&B).
Funding lines for young entrepreneurs usually flank Software out of scope (regarding IEC 82304-1) is for
supporting processes using advisors or coaches e.g., business example (see Fig. 1 C inter alia):
plans and foundation preparation [9]. In contrast, regulatory − Software that does not treat health issues of individuals.
know how and approval processes are hardly considered while − Hospital billing software
the demands continuously increase. − Software for epidemiological studies
− Training software
− Electronical logbooks
1.2 Objective − Software for scheduling the maintenance of medical
The aim of this orientation guide is the development of a devices.
decision tree using plain questions to identify whether the
planned software product is a medical device or a health
software product. Additionally, the terminology should be
clarified, and the necessary competences will be pointed out.
Later might help the young entrepreneurs or unexperienced
small enterprises to find the right strategy for placing their
product on the market.

2 Material and Methods

Based on a literature research, all relevant European
standards and guidelines were sighted. Requirements for the
software development and scopes were worked out to develop Figure 1: Regulatory scopes for software in the health
the decision tree. The following literature was used, and sector (Own representation based on IEC 82304)
relevant information was extracted and condensed:
− Regulation (EU) 2017/745
− IEC 62304
3.2 Decision Tree
− IEC 82304-1
− IMDRF- Software as a Medical Device Working Group. Software apps are intended for patients/users on the one
Software as a Medical Device (SaMD): Clinical hand and for healthcare professionals (physicians, nurses,
Evaluation therapists) or health organisations on the other. If the app
− MEDDEV-Guidance 2.1/6 is used for conception control for individual patients, it
− MDCG 2019-11

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Health Software Product or Software as Medical Device

Figure 2: Decision tree for the qualification of software as a medical device for the European Market. (A): is a medical device
thereby covered by MDR and DIN EN 82304-1. (B): no medical device but is covered by DIN EN 82304-1. (C): Does neither
fall under the scope of DIN EN 82304-1 nor the MDR. *Means a typical hospital information system that is also used for data
processing, not only for archiving purposes.

fulfils the requirements of a medical device and is covered considered to benefit individual patients does neither fall
by DIN EN 82304-1 and the Medical Device Regulation. in the scope of 82304-1 nor MDR. [10].
If the software is for self-tracking activities, such as
tracking step counters or nutrition and weight control
tools, and the app provides applications for fitness, 3.3 Competences
nutrition, wellness, or applications for better
understanding of health and disease, the requirements of Table 1: Overview for manufacturers what competences are

a medical device are not fulfilled [4]. However, it can still important based on the categorization of Fig.2.

be covered by DIN EN 82304-1. Cat. (Fig. 2) Competences and Effort

An essential indicator for the qualification of software as
A MDR must be fulfilled.
a medical device is the decision support for physicians Following standard might be relevant:
about therapeutic and diagnostic measures. For example, − EN 62304
for the presentation of clinical documents/images or for − EN 82304-1
monitoring a patient. If data are influenced by the app, for − EN 62366-1
example by drug dosages or measurement value − EN 14971
recordings, they also fulfil the requirements of a medical − EN 13485 (certification might be
device, provided that the results influence the diagnosis necessary)
or therapy of the patient. Software that is used for health
organisations for purely administrative purposes is B EN 82304-1 must be fulfilled.
This includes a risk assessment but no risk
explicitly not intended to be a medical device [2]. Pure
management according to EN 14971
data storage, documentation, communication, knowledge
C No explicit regulations of the health sector
provision, training, study organisation or billing do
applicable
neither lead to a qualification as a medical device nor fall
under the scope of DIN EN 82304-1. Software that is not

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Health Software Product or Software as Medical Device

4 Discussion References
[1] Rämsch-Günther N, Stern S, Lauer W. Abgrenzung und
The developed orientation guide uses a few simple Klassifizierung von Medical Apps: Was ist zu beachten und
questions/ assumptions that try to figure out the overall welche Unterstützung bietet das BfArM? Bonn:
Bundesgesundheitsblatt, Gesundheitsforschung,
intended purpose and the user profile.
Gesundheitsschutz. Springer-Verlag GmbH Deutschland.
The decision tree will help young entrepreneurs to 2018 January 18; 61: 304-313. Institute of Medicine (US).
roughly estimate the related effort and preliminary assess Looking at the future of the Medicaid program. Washington:
whether the application is a medical device or not. The Institute 1999.
[2] Pramann O. Gesundheits-Apps als Medizinprodukte. In:
Furthermore, it provides an overview of relevant standards and
Albrecht U.V. Chancen und Risiken von Gesundheits-Apps.
needed competences for the given path. The guide brings Hannover: Charismha; 2016: 228-243.
certainty and can help young entrepreneurs to identify the [3] Grand View Research. mHealth Apps Market Size, Share &
upcoming workload at an early stage. Due to the decision tree Trends Analysis Report By Type (Fitness, Medical), By
concept, it is easy to adapt the product-related strategy and see Region (North America, APAC, Europe, MEA, Latin
America), And Segment Forecasts, 2021 – 2028. Report ID:
the consequences. This might help entrepreneurs to find the GVR-1-68038-555-7. 2021.
right strategy for placing their product on the market. [4] Kramer U. Wie gut sind Gesundheits-Apps: Was bestimmt
Nevertheless, field testing with the orientation guide is Qualität & Risiko? Welche Orientierungshilfen gibt es?
necessary to validate its benefit. In addition, this approach Stuttgart: Georg Thieme Verlag KG. 2017; 42: 193-205.
[5] Keutzer L, Simonsson US. Medical Device Apps: An
needs further fine tuning and feedback from manufacturers.
Introduction to Regulatory Affairs for Developers. JMIR
Due to the simplicity of this decision tree, it does not cover all MHealth and UHealth. 2020.
conceivable applications. In case of doubt, further [6] The European Parliament and the Council of the European
considerations are necessary, and we would recommend Union. Regulation (EU) 2017/745. Official Journal of the
European Union 2017.
contacting a notified body.
[7] Giorgio V. Müller. Gesalzene Rechnung für die Medtech-
Prospectively, we will test the decision tree with the start- Firmen in Europa. 10.10.2017. URL:
ups, spin-offs and other small enterprises that contact the https://www.nzz.ch/wirtschaft/gesalzene-rechnung-fuer-die-
University of Applied Sciences searching for support and medtech-firmen-in-europa-ld.1320973. Accessed:
clarification for the development process of their innovative 19.11.2019.
[8] Julia Hagen und Wolfgang Lauer. Reiseführer gesucht –
applications in the field of health care. Ergebnisse einer Umfrage bei E Health-Start-ups.
Bundesgesundheitsblatt - Gesundheitsforschung –
Author Statement Gesundheitsschutz. March 2018, Volume 61, Issue 3, pp
Research funding: The author state no funding involved. 291–297.
[9] Richtlinie zur Förderung von Unternehmensgründungen
Conflict of interest: Authors state no conflict of interest.
(EXIST-Gründerstipendium) im Rahmen des Programms
Informed consent: Informed consent has been obtained from „Existenzgründungen aus der Wissenschaft“ – Neufassung –
all individuals included in this study. Ethical approval: The Vom 21. April 2020. Bundesministerium für Wirtschaft und
research related to human use complies with all the relevant Energie. Bundesanzeiger (Bekannmachung Veröffentlicht am
Mittwoch, 13. Mai 2020).
national regulations, institutional policies and was performed
[10] MDCG 2019-11: Guidance on Qualification and Classification
in accordance with the tenets of the Helsinki Declaration, and of Software in Regulation (EU) 2017/745 – MDR and
has been approved by the authors’ institutional review board Regulation (EU) 2017/746 – IVDR. Medical Device
or equivalent committee. Coordination Group. 2019. ..

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*Corresponding author: Michael Scholtes: Faculity of Health
Sciences - University of Applied Sciences Giessen, Wiesenstraße
14, Giessen, Germany, e-mail: michael.scholtes@ges.thm.de
Tabea Lukas, Keywan Sohrabi, Volker Gross: Faculity of
Health Sciences - University of Applied Sciences, Giessen,
Germany

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