When Software Becomes a Medical Device

Medical apps, therapy planning software program, and even firmware for ultrasound units: software program is legally labeled as a medical system whether it is used for medical functions. This contains diagnosing, inspecting, or predicting the course of a illness and influencing a remedy. The EU Medical Machine Regulation (MDR) even defines software program as an energetic medical system, in order that its classification would possibly rely on different guidelines apart from Rule 11.

In lots of circumstances, producers might not even remember that they’re growing a medical system, as a result of even well being and wellness apps for good telephones would possibly fall into this class. Since early 2020 medical apps may even be prescribed by physicians.1 The continued COVID-19 pandemic has emphasised and expanded the significance of digital well being applied sciences, starting from a speedy transition to telehealth providers, that are thought-about to be a breakthrough in incentivizing and advancing sufferers’ analysis, administration, and therapy with digital well being instruments.

Nevertheless, a digital well being software must qualify as a medical system to fulfil this function. To scale back prices and efforts, producers should first make clear whether or not their product is a medical system and verify which of the 4 danger courses (I, IIa, IIb, or III) outlined within the MDR or the transition rules applies to the product.2 This results in totally different necessities. For medical units of Class IIa and better, the MDR requires that notified our bodies have to be concerned, and a top quality administration system in keeping with the necessities in Annex IX of the regulation needs to be established.

The Medical Machine Coordination Group (MDCG), a world knowledgeable committee, supplies detailed steerage on software program qualification and classification in its publication MDCG 2019-11 of November 2019. The necessities and standards are specified within the EU rules on medical units (MDR 2017/745 – Annex VIII) and in-vitro diagnostics (IVDR 2017/746 – Annex VIII). In response to the definition of the MDCG steerage, the time period “medical system software program” covers packages utilized in mixture with a medical system, but in addition stand-alone software program with an meant function as outlined within the respective rules.

With the assistance of a flowchart, producers then decide step-by-step whether or not their software program qualifies as a medical system software program. Key facets embody meant use, particular person affected person advantages, and the applicability of the definition of software program. A coronavirus contact tracing app, for instance, just isn’t thought-about a medical system as it’s not influencing a person affected person’s analysis or remedy. In contrast, a smartwatch app that displays the center charge and thus impacts on remedy or analysis primarily based on knowledge evaluation consistent with its meant use is taken into account a medical system. The identical applies to software program controlling insulin pumps primarily based on the sugar degree inputs, as they calculate the right dosage along with controlling the medical system.

Relying on their degree of danger, potential medical units are divided into varied product courses. Courses I to III signify danger potential in relation to the meant function, location, and period of use. The traits are outlined within the MDR, Annex VIII. A notified physique then verifies that every one regulatory product necessities have been fulfilled. After demonstrating conformity with the MDR regulation, the producer affixes the CE marking to the product.

Classification Rule 11 is of explicit significance for software program builders. If software program is used to take selections with analysis, monitoring, or therapeutic functions, it falls into class IIa. If the medical system software program might incur the danger of extreme deterioration to sufferers’ well being primarily based on the data it supplies, the software program product falls into class IIb; if the data might end in irreversible deterioration of a affected person’s situation or demise, it falls into class III—the very best danger class. All different software program is assigned to class I. For extra help, see “Software program as a Medical Machine: Potential framework for danger categorization and corresponding issues” of the IMDRF (Worldwide Medical Machine Regulators Discussion board).

Within the danger administration process in accordance with ISO 14971, producers first outline a danger matrix together with standards of acceptance. Threat evaluation then supplies info as to which hazards may be derived from the meant use and which severities and chances are potential. If dangers are unacceptable, danger minimization measures can be outlined and carried out. Subsequently, producers must proceed this danger evaluation into the long run and re-evaluate their acceptance.

One other danger is poor usability: FDA analyses of remembers have proven that one-third of all incidents involving medical units (together with software program) are brought on by use errors. The worldwide IEC 62366-1 commonplace establishes usability necessities. It’s involved with figuring out potential dangers associated to usability and incorporating these into the danger administration course of. These dangers additionally embody bodily properties and ergonomic traits in addition to software program ergonomics—i.e., whether or not the software program is definitely understandable, intuitive, and shortly usable.

Within the European Union, the minimal necessities for the important thing lifecycle processes of software program for particular medical makes use of are harmonized with the IEC 62304 commonplace. This issues growth and upkeep, configuration, and danger administration in addition to downside fixing. Initially meant for each stand-alone and embedded options, in apply the usual is directed extra at embedded options. Additional necessities for stand-alone software program and the validation of well being software program are outlined by the IEC 82304-1 commonplace.

As well as, synthetic intelligence (AI) is more and more present in medical units, for instance to foretell the progress of illnesses or for picture evaluation. Nevertheless, selections have to be traceable and verifiable to make sure their use is secure for sufferers. In response to the overall security and efficiency necessities of the MDR, software program have to be designed to make sure repeatability, reliability, and efficiency consistent with its meant use. Producers can show compliance with this requirement by way of software program verification and validation.

Software program should moreover be designed in accordance with the cutting-edge and adjust to the rules of the software program life cycle, danger administration, and data safety. Hacker assaults on clinic networks or compromised medical units instantly jeopardize human lives. The COVID-19 pandemic and the attendant provision of well being providers on-line has prompted the general risk degree to rise. As a notified physique, TÜV SÜD Product Service gives testing and certification of software program for medical units in accordance with the related software program requirements.

App Shops as Retailers and Importers

Digital gross sales platforms that promote medical functions beneath their very own licence qualify as retailers. On this case, the non-profit commerce affiliation COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT Business) defines app shops as financial gamers, that are topic to MDR necessities. If producers are domiciled outdoors the EU, in addition they act as importers. In contrast, COCIR regards app shops that solely present their infrastructure for builders to distribute their software program instantly, as “marketplaces” not as market gamers.








  1. www.verbraucherzentrale.de/wissen/gesundheit-pflege/aerzte-und-kliniken/gesundheitsapps-medizinische-anwendungen-auf-rezept-41241
  2. www.johner-institut.de/weblog/tag/klassifizierung/