The AI Act is a Regulation, meaning it applies directly and uniformly across all member states without requiring national transposition. A system that has undergone conformity assessment and bears the CE marking is accepted across the single market without additional national conformity assessment. Member states cannot impose further conformity requirements on compliant systems, as this would contradict the Regulation’s direct applicability and the general internal market principles under the TFEU.

In practice, mutual recognition may be tested as national competent authorities develop their own interpretive approaches. The AISDP serves as the universal compliance evidence package; its completeness and rigour determine whether mutual recognition operates smoothly. An organisation with a thorough, well-evidenced AISDP can demonstrate compliance to any member state’s authority, regardless of where the initial assessment was conducted.

Where a competent authority challenges the system’s compliance despite CE marking and valid Declaration, the organisation’s response is grounded in the AISDP evidence pack. The Legal and Regulatory Advisor manages such challenges, referencing the AI Act’s direct applicability and the supporting evidence.

Key outputs

• Single market principle with CE marking acceptance
• AISDP as universal compliance evidence for all member states
• Article 23 reference for challenging national barriers
• Module 10 AISDP documentation