As Team-NB , we’d like to remind that AI Omnibus has no impact on the format of the conformity assessment of MDAI. An integrated procedure is and remains being foreseen as per Art. 43 (3) of the AIA and jointly clarified by MDCG and AI Board in MDCG 2025-6, Question 27. Likewise, there will be no impact of the decision to keep MDR and IVDR in Section A of Annex I (instead of moving them to Section B) on the requirements to be fulfilled by developers: Now, AIA requirements remain directly applicable. Otherwise, they would have been transferred into the GSPRs of MDR and IVDR.
However, the full applicability of the AIA on MDR and IVDR might make a de novo designation of medical device NBs under the AI Act unavoidable. We must highlight that the extension of transition periods by only one year to 02 August 2028 does not the match the fact that almost two years have already passed largely unused by legislators to enable national designation procedures of AI notified bodies.
Designation procedures can only commence after implementing acts on Union and national level have been adopted. Considering swift action of legislators, this might be the case in early 2027. This will leave less than two years for two critical steps:
First, the designation of notified bodies and, second, conformity assessment of MDAI before applicability of the AIA. Given previous experience with the implementation of product regulations, this seems to be a challenging expectation.
Even if national designation procedures, incl. coding system as proposed as an Annex to the AI Omnibus, are implemented in a pragmatic fashion as indicated in Art. 30 (5) of the AIA, these steps are unlikely to be fulfilled in time. In addition, the delay in the availability of harmonised standards will necessitate more complex conformity assessment procedures. If current policies are further pursued, we must expect readiness issues across stakeholders, heterogenic national implementations, bottlenecks, and capacity issues towards the end of the deadline, resulting in a failed implementation of the AI Act for medical devices and IVDs.