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Determining which health “apps” and/or software are considered medical devices varies according to the laws of each country. Is my health-oriented software or application a medical device?

There is no doubt that mobile phones and tablets with all their applications have represented technological advancement, and of course, these advancements have also affected the healthcare sector, leading to an ever-growing development of medical software and health-oriented applications. But

Since May 26, 2021, medical devices are regulated at the European level by the Regulation (EU) 2017/745 and in Spain by the Royal Decree 192/2023, of March 21, which regulates medical devices, recently coming into force.

In Article 2 of this Regulation 2017/745, and within the definition of a medical device it establishes that: “any instrument, device, equipment, software, implant, reagent, material or other article intended by the manufacturer to be used in humans, alone or in combination, for one or more of the following specific medical purposes: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation 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”.
Additionally, in the context of this Regulation, the “MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR” guide was published by the European Commission in October 2019 to facilitate the legal consideration and classification of software.

This guide includes, among others, the following definitions:
Software: A set of instructions that process input data and create output data. Medical device software: Software that can be used alone or in combination, for one of the purposes specified in the definition of a medical device in the Medical Devices and In Vitro Diagnostic Medical Devices Regulations. But is my application or software a medical device?
By way of brief clarification, not all software used in the healthcare field are medical devices.

Thus:
General-purpose software used within the framework of healthcare is not considered medical devices (e.g., software solely for patient management in a hospital, software for telemedicine consultations, etc.). Software that performs the following functions is also not considered medical devices: storage, archiving, communication, search, compression, and decompression of data.
For example, the following are considered medical devices: Software intended to calculate the radiation dose to be administered in radiotherapy treatments. Software that creates images of in vivo distribution of radiopharmaceuticals. Software for presenting heart rate. Software for controlling medication administration.

Thus, according to the above, only those modules or functionalities intended to process or interpret, with algorithms or artificial intelligence for example, initial information from a particular patient, such as their physiological parameters, to obtain new medical information on which a healthcare professional can base their therapeutic or diagnostic decisions, or that contribute to patient monitoring through the generation of alerts, would be considered medical devices, as they have a medical purpose as outlined in the previous definition. However, modules or functionalities intended to record, communicate, store, and/or archive information would not be considered medical devices. Likewise, those intended to perform statistical analysis on a population, as they are not intended for the benefit of an individual patient, would not be considered medical devices.

If you have any questions or need advice, at deviCE Sistemas we are experts in medical software and are at your disposal.
At deviCE we can help you correctly qualify your product, contact us and we will be happy to assist you.