Can software like ChatGPT be classified as a medical device in the sense of European law?
by Daniel Wurm
With the release of software version 3.0 by OpenAI, ChatGPT and artificial intelligence in general experienced a lot of hype, which is still lasting.
ChatGPT is able to produce individual texts, to conduct conversations and to answer any question in detail. For this purpose, ChatGPT uses data available on the Internet and converts it to the desired answer with the help of the AI algorithm.
In the meantime, ChatGPT is used millions of times a day by a large number of users and is one of the most user-intensive platforms on the Internet.
However, the success of OpenAI’s program is not running without legal hiccups. Besides problems in questions of copyright and data protection law, the discussion also reaches the sector of (European) medical device law and first voices demand the classification of ChatGPT as a medical device and therefore the implementation of a conformity assessment procedure.
For this, ChatGPT would have to constitute a medical device in the sense of Art. 2 No. 1 Regulation (EU) 2017/745 (“MDR”). According to the wording of the law, medical device means “…software […] which, according to the manufacturer, is intended for human use and […] is intended to fulfil the following specific medical purpose […]”. Under medical purpose are listed, for example, diagnosis, prevention or treatment of diseases.
In principle, it seems possible to catch ChatGPT under this definition. For example, if you enter symptoms into ChatGPT and ask what disease you might have, the program will list possible diseases. It could therefore be a medical product in the form of software that is used to diagnose diseases.
However, classification as a medical device solely on the basis of this does not go far enough and does not comply with the legal framework. Decisive for the classification as a medical device are not possible functions, but the subjective intended purpose of the manufacturer (see above: “…that according to the manufacturer…”).
The term intended purpose itself is defined in Art. 2 No. 12 Regulation (EU) 2017/745, according to which this means “the use for which a device is intended in accordance with the manufacturer’s indications on the label, in the instructions for use or in the advertising or sales material, or the advertising or sales claims and his statements in the clinical evaluation”.
Already in the example shown above, ChatGPT states at the end of its statement that it should not be a medical diagnosis and suggests that the questioner should consult a physician who can make a diagnosis.
Upon review of ChatGPT’s website and promotional materials, there is no evidence that any use for a medical purpose is intended. In addition, ChatGPT denies the question that it is a medical device. The main function would be texting.
Accordingly, ChatGPT is not a medical device. This also corresponds to the view of the European Court of Justice (ECJ), which clearly stated in a decision from 2012 (judgment of 22. 11. 2012 – C-219/11 – Brain Products GmbH/BioSemi VOF and others) that “[…] in cases where a product has not been designed by its manufacturer for use for medical purposes, certification of the product as a medical device cannot be required[…]”.
However, it should be noted that the ECJ in recent case law has already in a delimitation case between medicinal products and medical devices (judgment of 19.01.2023 – C-495/21, C-496/21) in its reasoning based on the averagely informed consumer as an indication for delimitation.
An inquiry of the German law office “Vorberg.law” to the Federal Institute for Drugs and Medical Devices (BfArM) answered the BfArM according to media reports in such a way that the adherence to the legal regulations of the medical device law is the obligation of the manufacturers and the monitoring of the adherence is task of the federal state authorities.
In summary, it can be said that ChatGPT does not constitute a medical device within the meaning of Regulation (EU) 2017/745 according to the current legal situation. However, it remains to be seen to what extent authorities and legislators consider further steps necessary in the future.
If you have further questions about the use of AI in medical devices, please feel free to contact us.
