Software as a medical device or in-vitro diagnostic device (part I)
Over the past years, software has become an essential tool in healthcare technology, revolutionising patient care. Several types of software are being used in healthcare settings, from efficient electronic systems to store patient information to innovative artificial intelligence that can accurately diagnose patients. While in Europe, the first example would be considered software for general purposes, the latter would qualify as a medical device (MD) or in vitro diagnostic medical device (IVD). This type of software is generally referred to as Software as Medical Device (SaMD) or, more commonly in Europe, Medical Device Software (MDSW).
What makes software a medical device?
According to the International Medical Device Regulators Forum (IMDRF), MDSW is defined as:
“Software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
In Europe (MDCG 2019-11), MDSW is defined as:
“Medical device software is software that is intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical device” in the medical devices regulation or in vitro diagnostic medical devices regulation.”
Thus, software serving a medical purpose is considered a medical device and, as such, shall comply with the EU Regulation 2017/745 (MDR) or EU Regulation 2017/746 (IVDR). In comparison with the previous directives, the regulations have additional requirements for MDSW. To obtain the CE-marking for an MDSW, manufacturers should consider three critical steps:
- Confirm that the software is an MD or IVD.
- Identify the Class of the MDSW.
- Comply with specific MDSW requirements in the regulations.
This article will focus on exploring the requisites for software to be considered a medical device.
Qualification of software as MD or IVD
The MDR Article 2 specifies that stand-alone software is an MD if it is intended to be used by the manufacturer for one of the following purposes:
- “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,”
Similarly, the IVDR Article 2 defines that software is an IVD if it is used to provide information on one or more of the following:
- concerning a physiological or pathological process or state;
- concerning congenital physical or mental impairments;
- concerning the predisposition to a medical condition or a disease;
- to determine the safety and compatibility with potential recipients;
- to predict treatment response or reactions;
- to define or monitoring therapeutic measures.”
In Europe, software can qualify as an MD or IVD regardless of the user (healthcare or lay person, healthy or sick individual), the technology used (complex or simple algorithms), or its risk. The qualification of software as MD or IVD solely depends on the device’s intended purpose and whether this meets the definition of MD or IVD in the regulations.
Software can also be considered MDSW if it is an accessory of an MD or IVD, or if it is listed in MDR Annex XVI (devices without medical purpose). Another important aspect to consider is whether the software performs any action on the data that is different from storage, archival, communication or simple search.
In addition to this definition, MDCG 2019-11 “Guidance on Qualification and Classification of Software” provides a figure with decision steps to facilitate software qualification as MDSW. More recently, an infographic has been released by MDCG with the same purpose.
What about fitness or wellness applications?
Whereas health and wellness apps provide information on life-style, fitness or well-being, MDSW provides information for the treatment or diagnosis of a disease or clinical condition; it has a medical purpose. The MDR mentions explicitly that fitness or wellness applications are not MDSW:
“Software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device“.
An interesting strategy for manufacturers could be first place their software on the market for general health purposes and use it to gain experience, collect data on usability and generate evidence until the evidence is sufficient to make a medical claim.
The increased use of MDSW has undeniably improved several aspects of patient care and management. The qualification criteria detailed in the MDR, IVDR and MDCG 2019-11 address previously identified gaps. In addition, correct classification and fulfillment of MDSW specific requirements complete the list of critical steps to successfully place an MDSW on the market while ensuring patient safety and device performance.
At AKRN Scientific Consulting SL, we are experts in MDSW. Our expert regulatory team can help manufacturers prepare or update the required documentation to fulfil the MDR or IVDR requirements to obtain or maintain the CE-mark.