For AI systems that are safety components of products covered by Annex I harmonisation legislation, the conformity assessment landscape involves coordination between the product notified body and the AI Act notified body (or internal assessor). Article 43(3) provides that the AI system conformity assessment may be carried out as part of the product conformity assessment.

Three coordination models are emerging. In the single-body model, one notified body is designated under both the product legislation and the AI Act and conducts an integrated assessment; this is simplest but requires dual competence, which is currently rare. In the sequential model, the product notified body conducts its assessment first, and the AI Act notified body then assesses AI-specific requirements using the product assessment as input; this preserves specialist expertise but extends the timeline. In the parallel model, both assessments proceed concurrently with a defined coordination protocol ensuring findings are shared.

The Conformity Assessment Coordinator engages with both bodies early to agree the coordination model, document exchange arrangements, and timeline dependencies. The AISDP and the product technical file are maintained as separate, cross-referenced documents rather than merged, to avoid version control complications and audience confusion.

Key outputs

• Coordination model selection (single-body, sequential, or parallel)
• Early engagement with both bodies for scope agreement
• Separate AISDP and product technical file with bidirectional cross-references
• Timeline dependency management