Regulation (EU) 2026/1744, also know as the Digital Omnibus on AI has now formally entered into force. The corresponding notification was published in the Official Journal of the EU.
As laid out in previous newsletter articles, the Omnibus contains a package of targeted measures designed to smooth the practical rollout of the EU Artificial Intelligence Act (AIA). The Digital Omnibus on AI is part of the broader Digital Omnibus package (touching aspects like the GDPR, the Data Act, NIS2).
It was initially hoped that the Digital Omnibus on AI would exempt medical devices from the scope of the AIA, but this was rejected. Some of the general amendments that are relevant for all stakeholders including manufacturers of medical devices are:
- For Annex I systems, including those within the medical devices regulations (MDR and IVDR), the full AIA high-risk requirements now apply no later than 2 August 2028 — a 12-month extension from the original August 2027 deadline for product-embedded AI.
- The Digital Omnibus on AI confirms that sectoral conformity assessments (such as under the MDR and IVDR) take precedence for high-risk AI systems that also fall into the scope of the MDR or IVDR. Article 43(3) of the AI Act provides for an integration of applicable requirements into the conformity assessment that already runs under the MDR or IVDR. The intent is a single integrated route with one integrated assessment, and a suitably designated notified body can cover both regimes.
- The European Commission gained authority to adopt delegated acts that can exempt specific AI Act high-risk requirements for medical devices if the MDR or IVDR already mandates equivalent standards. No such delegated acts have yet been adopted, so redundancy relief is a future mechanism, not present-day fact.
Industry associations like MedTech Europe now hope that the proposed amendments of the MDR and IVDR will be aligned as far as possible with the AIA so that duplicate regulation is reduced as far as possible.
Source: European Commission
