In brief

EU Regulation 2024/1689 on Artificial Intelligence has the aim to introduce strict rules for the design, implementation and placing on the market of Artificial Intelligence systems, to be applied both to suppliers established in European territory and to suppliers established outside the European Union.

Key takeaways

The impact of said Regulation on so-called SAMD (i.e., software as medical device) classified as “high risk” seems to materialize as significant. In this regard, it is worth noting how such obligations for AI systems classified as “high risk” will come into force as of 2 August 2027, while as of 2 August 2026, the Regulation will find general application.

There are still doubts as to how the Regulation will be implemented. For Class I medical device software, it seems clear that no notified body intervention is required for these and that they will not fall under the notion of “high-risk” AI SAMDs, provided that such SAMDs are not classified as medical devices, or as medical devices of class higher than I, due to the potential risks associated with their use.

For Legacy Class I medical device software (former MDD, i.e., Directive 93/42/EEC), there are still uncertainties from the combined reading of the new EU Regulation 2024/1689 on Artificial Intelligence with Regulation (EU) 2017/745 (Medical Device Regulation – MDR). It seems reasonable to assume that Class I SAMDs in MDD (i.e., Directive 93/42/EEC) that require the notified body in the MDR Regulation, can be placed on the market ex MDD until 31 December 2028, if they meet the conditions set forth in Article 120 of Regulation (EU) 2017/745. After that date, however, they must be marketed under the MDR Regulation in any case.

EU Regulation 2024/1689 on Artificial Intelligence, on the other hand, may not apply to in-house software MDDs, and this is in view of the fact that these are products for which there is no “placing on the market” under the MDR, given that they cannot be transferred to another natural or legal person other than the healthcare institution that created them.