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February 19, 2021 - Medical Devices + Diagnostics, European Union, Regulatory

Software as a Medical Device in Europe – New Regulatory Regime About to Enter into Force – (Part 2 of 6)

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In Part 2 of our series of consecutive articles on the reformed regulatory framework under the EU Medical Device Regulation 2017/745 (“MDR”), which will soon govern medical devices software (“MDSW”) in the EU, we will shed further light on the expansion of the definition of “medical device” and the importance of the intended purpose of healthcare-related standalone software in determining the regulatory requirements of companies offering such software in the EU.

Introduction: The Relevance of the Intended Purpose

As is already the case under the current EU Medical Device Directive 93/42/EEC (as amended by Directive 2007/47/EC – “MDD”), the purpose for which the software is intended to be used is and remains the critical factor when determining the obligations regarding regulatory compliance with the European medical devices regime. The intended purpose establishes whether standalone software is considered a medical device in the first place.[1]

In particular with regard to so-called health apps or other apps related to biological functions or wellbeing (e.g., related to fitness, diet, sleeping habits, or mental health), no bright line can be drawn between normal software and MDSW. For example, an app that allows the user to monitor his or her food habits for weight control purposes will qualify as normal software, while the same app might qualify as medical device if the monitoring is intended to be used for prevention of diseases such as metabolic disorders. A standalone software application that is claimed by its manufacturer to be a natural method of birth control and in which the user enters certain parameters (first day of menstruation, body basal temperature, etc.) in order to obtain the fertility window, should qualify as a medical device as it is intended to prevent pregnancy or facilitate conception.

The following table highlights some of the distinctions:

Medical purpose

Non-medical purpose

Prevention or diagnosis of disease or injury

Patient medical education (e.g., giving general health tips)

Treatment or alleviation of disease or injury (e.g., giving instructions to alleviate symptoms such as tinnitus)

Monitoring of general fitness (e.g., physical exercise tracker), general health, and general wellbeing (e.g., wellness diary)

Decision support or decision-making (e.g., with regard to therapeutic measures)

Communication or simple search functions (e.g., finding a certain healthcare specialist)

Control of conception

Storing and displaying medical data (e.g., weight or body fat) without any change or analysis

In this regard, we want to focus on three changes introduced by the MDR that are particularly noteworthy.

1. Expansion of the Definition of “Medical Device”

The MDR broadens the scope of medical purposes that are covered by adding new specifications to the list of relevant medical purposes. The full list of medical purposes under Article 2(2) of the MDR thus reads as follows (emphasis added to highlight the changes compared to the MDD):

  • Diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of disease;
  • Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability;
  • Investigation, replacement, or modification of the anatomy or of a physiological or pathological process or state;
  • Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations; or
  • Control or support of conception.

For standalone software, in particular, the addition of prediction and prognosis of disease can become relevant, e.g., for software providing healthcare professionals with information on a patient’s future health prospects or likely individual outcomes of a certain therapy. The importance of this addition also becomes palpable when looking at current COVID-19 apps. Based on a person’s recent contacts, such apps often make a prognosis with regard to the risk of the user developing COVID-19, while the app would not be in a position to actually diagnose the infection.

2. Expansion of Relevant Material and Product Life Cycle Approach

The MDR comprehensively includes further material to be considered when assessing the medical purpose. Under current law, according to Article 1(2)(g) of the MDD, “intended purpose” means the use for which the device is intended according to “the data supplied by the manufacturer on the labelling, in the instructions and/or in promotional materials.” In this regard, Article 2(12) of the MDR now also lists sales materials and statements to emphasize that any such information in whatever form given will be relevant. It also includes the specifications made by the manufacturer in the clinical evaluation (regarding the increased importance of the clinical evaluation, as we will describe in Part 4 of this series, available from March 5, 2021), which will require manufacturers to put even greater care on the framing of the intended purpose.

In line with the new product life cycle-focused approach of the MDR, it further intends to prohibit any attempts by the manufacturers to expand the intended purpose after the conformity assessment has been carried out. Article 7(d) of the MDR stipulates this expressly and prohibits the use of text, names, trademarks, pictures, or signs in the labelling; instructions for use; or making available, putting into service, and advertising of devices that are not in compliance with the intended purpose for which the conformity assessment was carried out.

3. The Intended Purpose Is Not the Only Factor Qualifying a Product as Medical Device

The MDR introduces in its Annex XVI groups of products (e.g., contact lenses) that irrespective of their intended purpose qualify as medical devices. While these product groups currently are not relevant with regard to standalone software, this may change as Annex XVI will likely be expanded over time.

Concluding Remarks

Even though the changes introduced to the regulation of software by the MDR may seem subtle at first glance, developers and stakeholders in the fields of digital health, fitness, and wellbeing should be aware that more products might be regulated in the foreseeable future. The MDR will make inevitable a careful assessment of the intended purpose of apps and other software products, which must cover every part of their documentation and advertisement. Framing the purpose of MDSW correctly will not only determine the applicability of the MDR but also potentially limit the scope of use for which an app can be marketed. Only a proactive and consistent approach in this regard will prevent any interference by the competent authorities and secure a smooth transition into the future market under the MDR.

[1] Software also falls under the MDR’s framework if the software is intended for controlling or influencing the performance of medical devices or is an “accessory for a medical device” within the meaning of Article 2(2) of the MDR. In this series, however, we focus on standalone software.