When you develop software that has something to do with health applications, it usually becomes complicated. If you want to market such software in Europe, you have to answer a crucial question: Is it medical software or not? The Medical Device Regulation (EU MDR) provides the regulatory framework to answer this question. In particular, it distinguishes between software as part of a medical device and stand-alone software. In this article we will show you how to classify software according to the EU MDR.
- Check if the Software Is Part of a Medical Device
- Specify the Intended Purpose of The Stand-Alone Software
- Check Whether the Stand-Alone Software Meets the Definition of a Medical Device
- Examples for Stand-Alone Software as Medical Device
- Definitely not a Medical Device
- It Depends on the Function
- Modules of Stand-Alone Software
- Our Recommendations
Check if the Software Is Part of a Medical DeviceInterestingly, the EU-MDR does not define the term “software”. However, you can follow the definition in the EU Commission’s MEDDEV 2.1/6 guide of July 2016. You should note that the MEDDEV guidelines generally refer to the former EU directives (MDD) and not to the EU MDR. From a regulatory point of view, you can distinguish the following types of software:
|Type of Software||Brief Description|
|Embedded Software||The software is part of a medical device, e.g. a patient monitor.|
|Software as Accessory||The software supports the use or medical function of the medical device, e. g. as service software.|
|Stand-alone Software||The software is a medical device on its own, e.g. a medical app or decision support software.|
Specify the Intended Purpose of The Stand-Alone SoftwareIn the next step, you must define a purpose for the software that describes its later use in detail. The exact description of the intended purpose is important and strongly influences whether the software is to be regarded as a medical device or not. The description of the intended purpose must comply with the details
- supplied by the manufacturer on the label,
- given in the instructions for use,
- given in promotional or sales materials or statements, and
- as specified by the manufacturer in the clinical evaluation (Art. 2 (12) EU MDR).
- the intended medical benefit (diagnosis, therapy or monitoring of disease or injury),
- the functional principle (for example, in the case of software usually the underlying algorithm),
- the intended use context (e.g. ambient brightness), and
- the intended user (e.g. medical professionals versus patients).
Note, however, that the intended purpose must not arbitrarily exclude medical use to circumvent the regulatory requirements for medical devices. This has been stated by the Court of Justice of the European Union (CJEU) or the German Federal Supreme Court (BGH) in the past.
Check Whether the Stand-Alone Software Meets the Definition of a Medical DeviceSoftware is a medical device if it meets the definition in Art. 2 (1) EU MDR. The definition is based on the areas of application. These are:
- 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, and
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations.
- Is the software output data used for a medical purpose as described in the medical device definition?
- Does the intended purpose include terms such as “alert, analyze, calculate, detect, diagnose, interpret, convert, measure, control, monitor, or amplify”?
- Does the software change or interpret its input data?
- Is the software intended to be used for or on humans?
Examples for Stand-Alone Software as Medical DeviceLet’s look at an example from the EU Commission’s “Manual on Borderline and Classification” of April 2018. The manual describes a medical app, which:
- compares photos of patient’s moles with a database of diagnosed melanomas using an algorithm, and
- based on this comparison, evaluates the photographed moles in detail and displays the probability for the moles to be a melanoma.
- radiotherapy planning systems for the dosage calculation of ionizing radiation in cancer therapy,
- drug planning systems to prevent resistance during chemotherapy or antibiotic treatment, and
- computer-assisted detection systems for imaging of cancer or coronary heart disease.
Definitely not a Medical DeviceNot all software used in health care facilities is a medical device (recital 19 EU MDR). This includes the so-called “software for general purposes”, which can be, for example, an office package or the operating system. Software intended for “lifestyle and well-being purposes” is also not a medical device. An example of this is a fitness app that records the user’s physical activities.
Note, however, that the transition from this so-called “health software” to a medical device can be smooth. This also applies to lifestyle hardware products such as the Apple Watch Series 4, which has been approved by the FDA as a medical device for its electrocardiogram (ECG) function.
It Depends on the FunctionAccording to MEDDEV 2.1/6 consider the following functions as indicators for software not being a medical device:
- lossless compression, or
- simply search of data.