Harmonised standards to the AI Act – for medical devices, too

The European Union artificial intelligence act (AI Act) establishes the rules for the application of artificial intelligence (AI) systems within the European Union. The AI Act is to be complemented with the harmonised standards that provide the presumption of conformity to the AI Act if implemented fully in the organisation that provides the AI system. The joint technical committee 21 (JTC 21) of CEN and CENELEC has been assigned the responsibility to prepare these standards. Work is under way to develop standards for AI risk management, AI cybersecurity, AI quality management, Quality and governance of datasets in AI, AI trustworthiness framework and AI conformity assessment. As medical devices incorporating an AI component are also within scope of the AI Act, these standards apply to medical devices, too. For this reason, medical device experts need to contribute to the AI standardisation work so that the resulting standards will be feasible in the health sector. The challenge in the work is to make several standards good and compatible with each other in the presence of a plurality of opinions and a hurry to produce the standards in time.