The much-needed harmonisation between the AI Act and MDR/IVDR – #BHHMembersInitiatives

Alejandro Bes, head of legal of BHH member Novartis, and Francisco Javier García Pérez, counsel of Uría Menéndez look at the proposed EU AI Act. This new proposal has raised many concerns such as if medical devices using AI shall also be notified to other bodies and the liability regime applicable to medical device manufacturers.

The European Union is currently making considerable efforts to update its current legislative framework and adapt it to the digital era. On 21 April 2021, the European Commission issued a Proposal for a Regulation of the European Parliament and of the Council laying down harmonised rules on artificial intelligence and amending certain union legislative acts (AI Act). The AI Act aims to improve the functioning of the internal market by establishing a uniform legal framework to govern the development, marketing, and use of artificial intelligence (AI) in conformity with European Union values.

The AI Act will not only affect European Union-based companies, given that Article 2 provides that it would apply to (a) providers placing on the market or putting into service AI systems in the Union, irrespective of whether they are established in the European Union or a third country; (b) users of AI systems located in the European Union; and (c) providers and users of AI systems located in a third country, where the system’s output is used in the European Union. In other words, the AI Act may affect many companies worldwide as long as they are in any way connected (including only commercially) with the European Union.

Make sure to read the long length article by Alejandro Bes and Francisco Javier García Pérez HERE.