Is My Software a Medical Device?
This article focuses on stand alone software active in the European Market and subject to the Medical Device Regulation.
Establishing whether your software product is a medical device or not, can be tricky. While the MDCG provides additional insights on the topic, the MDR’s definition of Medical Device Software (MDSW) remains unclear for many healthcare software organizations.
According to the MDR, software becomes a medical device when it is specifically intended by the manufacturer for medical purposes. Regardless of its functionalities, software will be classified as a medical device if its intended purpose are therapy, diagnosis or prevention of diseases. To clarify, “intended purpose” is defined by the MDR as the use for which a device is intended based on the information provided by the manufacturer on the label, in the instructions for use, or in promotional or sales materials, as well as what is specified by the manufacturer in the clinical evaluation.
So, in addition to the intended purpose we must also consider how organizations communicate and market their software products. And while these are the main aspects of the MDR that should address the question posed in the title, confusion still persists and guidance is often sought.
Now, let’s examine a few examples to illustrate these concepts.
A Patient Scheduling System that facilitates the scheduling of appointments between patients and healthcare providers will not be classified as MDSW. With an intended administrative purpose, this product focuses on managing appointments, reminders and patient flow rather than having a direct impact on the patient’s diagnosis or treatment. Additionally, the software does not offer clinical decision support or recommendations based on patient data. In conclusion, while used in healthcare and contributing to the improvement of patients’ access to care, this product does not directly influence medical outcomes or patients’ heath making it a Healthcare Software without being classified as a Medical Device Software.
In contrast, radiology imaging software used for analyzing and interpreting medical images, such as MRIs, or CT scans is a clear example of a software classified as medical device. With a defined intended purpose of assisting healthcare professionals in diagnosing medical conditions by analyzing imaging data, this software may provide decision support by highlighting areas of concern in the images and suggesting potential diagnoses, therefore influencing treatment decisions and directly impacting patient health outcomes. In conclusion, If you plan to introduce your software as a medical device in the European market, it is crucial to review the Medical Device Regulation and fully understand the associated requirements and obligations.