Regulation simplifying the implementation of the harmonised rules on artificial intelligence (Digital Omnibus on AI). It amends the AI Act (Regulation (EU) 2024/1689) together with Regulations (EU) 2018/1139 and (EU) 2023/1230. Dated 8 July 2026 and published in the Official Journal on 24 July 2026, it enters into force on the third day following publication. The date of application of Sections 1 to 3 of Chapter III of the AI Act is set to 2 December 2027 for AI systems classified as high-risk under Article 6(2) and Annex III, and to 2 August 2028 for those classified as high-risk under Article 6(1) and Annex I, which covers AI embedded in products such as medical devices.

EU regulation establishing a risk-based framework for artificial intelligence, dated 13 June 2024 and published in the Official Journal on 12 July 2024. It sets out prohibited practices and requirements for high-risk AI systems. Medical device AI becomes high-risk where it is a safety component of a device, or is itself a device, and is subject to third-party conformity assessment by a notified body (MDCG 2025-6). Requirements for high-risk systems cover data governance, technical documentation, transparency, human oversight, and accuracy, robustness and cybersecurity; a single set of technical documentation is drawn up for the MDR or IVDR and the AI Act. Article 99 sets maximum fines of EUR 35 million or 7% of worldwide annual turnover for prohibited practices, and EUR 15 million or 3% for breaches of operator obligations, whichever is higher. As amended by Regulation (EU) 2026/1744, the high-risk requirements apply from 2 December 2027 for Annex III systems and from 2 August 2028 for Annex I products, which include medical devices.

EU regulation on in vitro diagnostic medical devices, dated 5 April 2017, published in the Official Journal on 5 May 2017 and applicable since 26 May 2022. It repeals Directive 98/79/EC and Commission Decision 2010/227/EU and governs placing on the market, conformity assessment and post-market obligations for devices, including software. The classification rules are set out in Annex VIII, with MDCG 2020-16 providing guidance on their interpretation, and the general safety and performance requirements, including those relevant to cybersecurity, are set out in Annex I. The transitional periods were extended by Regulations (EU) 2022/112 and (EU) 2023/607. To be read together with MDCG 2019-11 on qualification and classification of software, which covers both the MDR and the IVDR.

EU regulation on medical devices, dated 5 April 2017, published in the Official Journal on 5 May 2017, in force since 25 May 2017 and applicable since 26 May 2021. It repeals Council Directives 90/385/EEC and 93/42/EEC and governs placing on the market, conformity assessment and post-market obligations for devices, including software. Software is classified under Rule 11 of Annex VIII, and the general safety and performance requirements, including those relevant to cybersecurity, are set out in Annex I. The transitional period was extended by Regulation (EU) 2023/607, and Regulation (EU) 2024/1860 provided among other things for the gradual roll-out of Eudamed. To be read together with guidance such as MDCG 2019-11 on qualification and classification of software and MDCG 2019-16 rev.1 on cybersecurity.