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.