Is my software a medical device under European regulation?
After entering into force on 26 May, the EU MDR still presents areas of ambiguity. Such is the case for requirements concerning the qualification of software as a medical device. This article is a translated version of the work done by Frédéric Barbot, Clinical Investigation Center (CIC 1429) Raymond Poincaré hospital (Garches, France), and published in the online French Magazine, DeviceMed. Frédéric sheds some light on medical device software while relying on the MDCG 2019-11 guidance.
As a preamble, we take note that the classification of software, specifically with regards to Rule 11 of Annex VIII (tricky topic), and the qualification of in vitro diagnostics (Regulation (EU) 2017/746) are not discussed here.
Organizations that develop software, especially SMEs, start-ups, and university spin-off companies, must carefully examine the requirements of Regulation (EU) 2017/745 regarding medical devices (MDR) to determine if their product can be defined as a medical device.
Many startups will take on the European regulation for the first time and, as a result, have to be in conformance with the regulatory requirements regarding software. According to the MDR's classification, the majority of software that was previously class I under Directive 93/42/EEC will now find itself as class IIa at a minimum and therefore require CE marking through a notified body.
It's a matter of definition
The term "software" is used in the European regulation to identify digital devices subject to the new requirements. However, the terms "algorithms" (Section 6.5.2 of Annex VI, Part C; Section 3 of Annex XIV, Part A) and "mobile computing platforms" (Section 17.3 of Annex I, Chapter II) are mentioned throughout the MDR text.
Furthermore, the European regulation does not define the term "software", even if that software meets the definition of a medical device (as per Article 2.1). Rather, the term is defined in the guidance document MDCG 2019-11 (Guidance on Qualification and Classification of Software in Regulation):
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.
Essential guidance on qualification of software
The 28-page long MDCG 2019-11 guidance was published in October 2019 by the Medical Device Coordination Group. This document determines the qualification and classification of software according to the MDR. Its guidelines are essential for organizations that develop software, who should, in turn, be aware of it as a matter of priority. While these guidelines are not legally binding and do not reflect the official position of the European Commission, judges of the Court of Justice of the European Union may rely on them. Organizations that develop software must be aware of these regulatory changes.
Most crucial to remember is that this MDCG 2019-11 guidance provides a 5-step decision tree to qualify a medical device software. These are critical elements of interpretation for organizations that develop software, with qualification being on a case-by-case basis. Software must meet the following criteria to be qualified as a medical device:
intended to be used for medical purposes, according to the MDR definition (Article 2.1);
enables, for example, diagnosis, diagnostic aid, treatment or aid thereof;
performs an action based on incoming data, such as analysis, in order to provide new medical information;
gives a precise result for the benefit of a single patient
If the medical purpose of the software is to analyse, compute, modify, generate, diagnose, predict, forecast, interpret, alert, control, measure, or monitor, it is qualified as a medical device.
If the function of the software is to ensure storage, archiving, retrieval, compression, or communication of data, it does not fall under the definition of a medical device. The same applies to "well-being" and "lifestyle" software, where there is no medical purpose. However, if the software is a device mentioned in Annex XVI (list of 6 categories of products without an intended medical purpose or with an aesthetic function, but relevant to the scope of the MDR), it is covered by the European regulation.
Similarly, if the software is an accessory to a medical device (as per Article 2.2), or if it controls or influences the use of a medical device, it falls within the scope of the MDR. Therefore, the software can function as a medical device in itself (software as a medical device) or in combination with a medical device (software as a part of a device).
Note: the risk associated with the use of the software is not a qualification criterion.
Making a strategic choice
The qualification of software may be a strategic choice for an organization. After all, it is the manufacturer that determines whether or not its software should be a medical device (for example, well-being and lifestyle software) and consequently prepare itself for a medical CE marking or a "simple" one instead.
Remaining to be followed, if you hope to attain medical CE marking, are the specific rules of the MDR (especially those regarding general safety and performance requirements, as defined in Annex I) and the evaluation of conformity assessments.