AI Compliance

    The map of regulations and where to start

    AI Act, Cyber Resilience Act, NIS2, ISO/IEC 42001, GDPR, copyright: a single framework to govern the obligations that touch AI, with the AI Rating measuring the distance from requirements.

    AI compliance becomes concrete when someone asks for evidence: a risk committee that wants the AI system register, an enterprise client that puts it among the supplier qualification criteria, an audit that asks who approved that model and what data it was trained on.

    The European framework is not a single rule, but a system of regulations, directives and standards overlapping across different areas: system risk, infrastructure security, data protection, intellectual property.

    The Italian context (Artificial Intelligence Observatory, Politecnico di Milano, 2025 edition):

    • 71% of large Italian companies have active AI projects
    • 9% have structured AI governance
    • The remaining 91% handles every request for evidence from scratch, with costs and timelines growing at each tender, audit or renewal

    This page maps the main regulations that touch AI and shows where each one connects to ZeroFive.AI's AI Rating model, which measures the distance between the current state and the requirements.

    Deadlines in order

    • 2 August 2026AI Act: transparency obligations of Article 50 and penalty regime
    • 11 September 2026CRA: reporting of actively exploited vulnerabilities and severe incidents
    • 2 December 2026AI Act: machine-readable marking of generated content
    • 2 December 2027AI Act: high-risk systems under Annex III
    • 11 December 2027CRA: essential cybersecurity requirements under Annex I
    • 2 August 2028AI Act: high-risk systems embedded in Annex I products

    AI Act calendar updated to Regulation (EU) 2026/1744. Cyber Resilience Act dates follow Regulation (EU) 2024/2847.

    EU AI Act: the reference regulation

    EU Regulation 2024/1689 introduces a risk-based approach: AI systems are classified from minimal to unacceptable risk, with proportionate obligations that include impact assessments, system registers, transparency toward users, effective human oversight and a continuous, documented risk management system. The obligations do not fall only on developers: deployers, the organizations that use AI systems in their own processes, also carry direct responsibilities, in particular for high-risk systems. The application calendar was rewritten by Regulation (EU) 2026/1744, published in the Official Journal on 24 July 2026: the transparency obligations of Article 50 and the penalty regime apply from 2 August 2026, the high-risk requirements of Annex III from 2 December 2027, and the requirements for systems embedded in products already regulated under Annex I from 2 August 2028.

    In the AI Rating model every key requirement of the regulation is mapped to an assessment dimension, so the assessment works as a preliminary gap analysis for compliance: each gap found already comes linked to the relevant regulatory reference and the corrective action.

    ISO/IEC 42001: the AI management standard

    ISO/IEC 42001:2023 is the first certifiable international standard for AI management systems. It defines the system through which an organization governs AI on an ongoing basis, from policies to operational controls, with the same logic ISO/IEC 27001 uses to govern information security. It is the standard closest to the spirit of the AI Act and is entering supplier qualifications as third-party verified proof that the stated governance actually exists. From 13 March 2026 the standard is also a European norm: CEN adopted it unchanged as EN ISO/IEC 42001:2026, with national standardization bodies expected to transpose it by September 2026.

    The ZeroFive.AI framework is built in line with the standard: implementing the recommendations that come out of the rating means, in substance, walking the path toward its requirements, with the advantage of knowing in advance where you are behind and how much it costs to close the gap.

    NIS2 and the supply chain

    EU Directive 2022/2555, transposed in Italy through Legislative Decree 138/2024, imposes security obligations on essential and important entities that extend to the supply chain. A company within the NIS2 perimeter that integrates AI vendors into its processes must evaluate, contract and monitor them as part of its own risk perimeter, and those who sell AI solutions to those entities should expect to be assessed by that same yardstick.

    AI governance and cyber security meet here: the assessment engages with the controls the CISO has already built, without duplicating them, and gives the risk committee a single view of where AI systems expose the organization.

    Cyber Resilience Act: security of products with digital elements

    Regulation (EU) 2024/2847 imposes cybersecurity requirements on anyone placing products with digital elements on the European market, a category that includes software distributed as a product and not only connected devices. The perimeter differs from NIS2, which targets essential and important entities: here the criterion is placing the product on the market, and this brings within scope many software houses and vendors that fall outside the NIS2 perimeter. The calendar is staggered: the regulation has been in force since 10 December 2024, Chapter IV on market surveillance authorities applies from 11 June 2026, the reporting obligations of Article 14 from 11 September 2026, and the essential requirements of Annex I from 11 December 2027.

    The part already in force changes teams' daily work. Anyone who becomes aware of an actively exploited vulnerability must submit an initial alert within twenty-four hours, a full notification within seventy-two hours and a final report within fourteen days of a corrective measure becoming available; for a severe incident the initial sequence is identical and the final report is due within one month. The channel is the Single Reporting Platform managed by ENISA, with a single submission addressed to the CSIRT designated as coordinator, which in Italy operates within the National Cybersecurity Agency. The obligation also applies to products already made available on the market before 11 December 2027.

    Full application of the CRA falls nine days after the AI Act obligations for the high-risk systems of Annex III. For those developing or integrating software with AI components intended for the European market, this is effectively a single preparation window, with evidence that overlaps substantially: system registers, risk management, version traceability, supplier requirements. In the rating this evidence is assessed once, without opening two parallel workstreams that ask the same documents of two different parts of the company.

    On the proposal front, the cyber package presented by the Commission on 20 January 2026 would replace the 2019 Cybersecurity Act with a new regulation (COM(2026) 11) and would amend NIS2 in a targeted way (COM(2026) 13). The block that most directly affects technology buyers concerns the ICT supply chain: the Commission could designate third countries as raising cybersecurity concerns, classify vendors controlled by them as high risk and impose equipment phase-out periods. The text is under negotiation, and in the progress report of 22 May 2026 the Council asked for clarifications on the identification methodology, so it should be treated as a signal of direction rather than an imminent obligation. Supply decisions taken in the coming months will still play out within that framework.

    Personal data and security: GDPR and the ISO 27000 family

    Every AI system that processes personal data remains subject to the GDPR, from data minimization principles to privacy impact assessments. Around the regulation sit the security standards procurement has requested for years: ISO/IEC 27001 for the information security management system, ISO/IEC 27017 for cloud-specific controls, ISO/IEC 27018 for the protection of personal data in the public cloud. A model trained or fed with personal data inherits all the protection obligations attached to that data, and the two compliance tracks, privacy and AI, need to be read together.

    ZeroFive.AI does not issue certifications, and we say this clearly: we measure the distance from requirements, prepare the organization for engagement with certification bodies and client audits, and build the evidence those paths require.

    Where each regulation meets the AI Rating

    The AI Rating assesses AI maturity across four dimensions (Readiness, Delivery, Risk, Confidence), with a 0-5 score and A-D classes. Regulations do not live in a separate chapter of the model: they run through every dimension, and that is what makes the rating usable as a single gap analysis instead of four parallel compliance projects.

    Regulatory requirementWhere the AI Rating measures itWhat it produces
    AI Act, risk management systemAI Risk, with critical non-compensable gates on compliance and ethicsReview of risk assessment and mitigation processes, system register
    AI Act, data governance and data qualityAI ReadinessAnalysis of data quality, lineage and anti-bias measures in datasets
    AI Act, human oversightAI ConfidenceReview of human-in-the-loop processes and operator training
    AI Act, accuracy and cybersecurityAI DeliveryAudit of MLOps practices, production monitoring and infrastructure security
    ISO/IEC 42001, AI management systemAI Risk and AI ConfidencePre-assessment against the standard's requirements, evidence for the certification body
    NIS2, supply chain securityAI Risk and AI DeliveryAssessment of AI vendors and system robustness within the risk perimeter
    CRA, vulnerability management and reporting obligationsAI Risk and AI DeliveryReview of detection processes, notification timelines and the chain of responsibility toward CSIRTs and ENISA
    CRA, essential cybersecurity requirements and software bill of materialsAI DeliveryAnalysis of development lifecycle security, the SBOM and the product update policy
    GDPR and ISO 27018, personal dataAI Readiness and AI RiskMapping of processing activities within AI flows, alignment with the DPO and existing privacy controls
    Copyright Directive and GPAI obligationsAI RiskReview of vendors' contractual guarantees and internal usage policies

    Critical gates: legal and ethical compliance are not compensable. A company that excels at everything else but is exposed on these fronts does not get a high rating, because in reality that risk is not offset by anything else. In the report every gap is cited with the relevant regulatory reference, from the absence of an AI system register to the lack of a continuous risk management process.

    Frequently asked questions

    Does the AI Act also apply to those who use AI, not just those who develop it?

    Yes. The regulation also assigns obligations to deployers, the organizations that use AI systems, particularly high-risk ones: human oversight and monitoring of the systems, plus the obligation to inform the people involved.

    Is ISO/IEC 42001 mandatory?

    No, it is a voluntary standard. It is however becoming a de facto requirement in tenders and supplier qualifications, because it demonstrates through third-party verification that the stated AI governance actually exists.

    Does ZeroFive.AI certify compliance?

    No. We do gap analysis, alignment and preparation. Certification belongs to accredited bodies, legal opinions to law firms. Our work makes both paths faster and less costly.

    Do you need a separate compliance project for every regulation?

    No, and that is the most costly mistake. The regulations share most of the required evidence: a well-kept system register answers the AI Act, feeds ISO 42001 and simplifies NIS2 audits. The AI Rating builds that common base once.

    Does the Cyber Resilience Act also apply to those who only sell software?

    Yes, when the software is placed on the market as a product. Purely cloud services stay out, falling instead under NIS2, while remote data processing solutions necessary for the product's functions fall within the perimeter. The check must be made product by product, before the next supply contract.

    Where is it best to start?

    With a measurement. The AI Rating captures, in 3-4 weeks, the distance between the current state and the relevant regulatory requirements, with a 90-day roadmap and priorities. Deciding before investing costs less than fixing it afterward.

    How we start

    Starting an AI consulting engagement in three steps

    A clear path from first contact to the investment decision, with no upfront commitment.

    01

    30-minute call

    We frame goals, constraints and risk level. No licences to sell, no channel agreements.

    02

    Preliminary assessment

    With AI Rating we measure AI maturity on a 1-5 scale and the distance from EU AI Act and ISO/IEC 42001 requirements.

    03

    Tailored engagement

    We define priorities, timing and ownership: validation with PROTOT.AI and, if the case holds, governed production rollout.

    Want to know where you stand on AI Act, CRA, NIS2 and ISO 42001?

    Book a 30-minute call or start with the free preliminary AI Rating assessment.

    Or write to hello@zerofive.ai