The Cyber Resilience Act and the EU AI Act are separate regulations with separate scopes, separate authorities, and separate penalty regimes. CRA and EU AI Act apply concurrently to a large and growing category of products: AI systems that are also products with digital elements.
An AI-powered connected device, an AI feature embedded in commercial software, or an AI system distributed as a standalone software product will frequently fall within both. Where that happens, both sets of obligations apply in full. Neither displaces the other.
The overlap between CRA and EU AI Act is not evenly distributed. Cybersecurity requirements duplicate substantially and can be satisfied once. Documentation requirements overlap in content but differ in structure and recipient. Reporting obligations run on different clocks to different bodies and cannot be consolidated. Conformity assessment routes are separate exercises.
The most immediate practical issue is timing. nd bound on 11 September 2026. AI Act enforcement for GPAI models began on 2 August 2026. High-risk AI obligations follow in December 2027 and CRA full application in December 2027. Organisations subject to both CRA and EU AI Act are managing four distinct compliance deadlines across eighteen months.
Key Definitions: CRA and EU AI Act
| Term | Definition |
|---|---|
| CRA | Cyber Resilience Act, Regulation (EU) 2024/2847. In force since 10 December 2024 |
| EU AI Act | Regulation (EU) 2024/1689, as amended by Regulation (EU) 2026/1744 |
| Product with digital elements | Any software or hardware product, and its remote data processing solutions, placed on the EU market with a direct or indirect data connection |
| High-risk AI system | An AI system under Article 6 of the AI Act, either an Annex I product safety component or an Annex III use case |
| Manufacturer | The CRA term for the entity placing a product on the EU market under its own name |
| Provider | The AI Act term for the entity placing an AI system on the market under its own name |
| SBOM | Software bill of materials. Required under CRA Annex I |
| Annex IV | The AI Act technical documentation requirements for high-risk AI systems |
| SRP | Single Reporting Platform. The ENISA-operated CRA reporting channel |
| Notified body | An independent conformity assessment body designated under either regulation |
Do Both CRA and EU AI Act Regulations Apply to the Same Product?
Frequently, yes. The scope tests are independent and a product can satisfy both.
CRA scope. Any product with digital elements placed on the EU market. This means any software or hardware product whose intended or reasonably foreseeable use includes a direct or indirect data connection to a device or network. In practice this covers most modern software and most connected hardware.
AI Act scope. Any AI system placed on the EU market or put into service, or whose output is used in the EU. Obligations scale by risk tier, with the substantive requirements concentrated on high-risk systems and GPAI models.
The intersection is large:
| Product | CRA applies | AI Act applies | Combined position |
|---|---|---|---|
| AI-powered CV screening SaaS | Yes, software with digital elements | Yes, Annex III employment | Full CRA plus full high-risk AI Act |
| Connected medical device with AI diagnostics | CRA excluded, MDR governs | Yes, Annex I product safety route | AI Act plus MDR, CRA carve-out applies |
| AI-enabled industrial sensor | Yes | Depends on Machinery Regulation position post-Omnibus | Assess both, classification uncertain |
| Enterprise chatbot product | Yes | Limited risk, Article 50 transparency | CRA in full, AI Act transparency only |
| Standalone GPAI model via API | Yes if placed on market as a product | Yes, Chapter V | CRA plus GPAI obligations |
| Smart home camera with facial recognition | Yes, Important Class I | Yes, Annex III biometrics | Full CRA plus full high-risk AI Act |
| Non-AI connected thermostat | Yes | No | CRA only |
| AI model used purely internally, never placed on market | No | Depends on putting into service | Assess separately |
The Sector Carve-Outs
The CRA excludes products already covered by equivalent sector cybersecurity regimes, including medical devices under the MDR and IVDR, motor vehicles, and civil aviation products. The AI Act does not exclude these; it routes them through the Annex I product safety pathway instead.
The consequence is asymmetric. A medical device with AI diagnostics is outside the CRA but firmly inside the AI Act. An industrial connected sensor may be inside the CRA and, following the Digital Omnibus, in an uncertain position under the AI Act because the Machinery Regulation moved from Annex I Section A to Section B.
Where CRA and EU AI Act Obligations Overlap
Cybersecurity Requirements
This is where the duplication is greatest and where a single body of work can satisfy both.
AI Act Article 15 requires high-risk AI systems to achieve an appropriate level of accuracy, robustness, and cybersecurity, and to be resilient against attempts by unauthorised third parties to alter their use, outputs, or performance by exploiting system vulnerabilities.
CRA Annex I requires products with digital elements to be designed and developed to ensure an appropriate level of cybersecurity, delivered without known exploitable vulnerabilities, with secure default configuration and appropriate protection against unauthorised access.
The specific AI threat vectors, data poisoning, model poisoning, adversarial examples, and model extraction, are addressed under AI Act Article 15 and are within the CRA’s general security requirement for products containing AI components.
| Requirement | AI Act | CRA |
|---|---|---|
| Cybersecurity by design | Article 15(5) | Annex I, Part I |
| No known exploitable vulnerabilities at release | Implicit in Article 15 | Annex I, Part I, explicit |
| Secure default configuration | Not expressly required | Annex I, Part I, explicit |
| Resilience to adversarial manipulation | Article 15(5), AI-specific | Annex I general requirement |
| Vulnerability handling process | Not expressly required | Annex I, Part II, explicit |
| Security updates for support period | Not expressly required | Annex I, Part II, explicit |
A security programme built to CRA Annex I will substantially cover AI Act Article 15. The reverse is not true: Article 15 does not require a vulnerability handling process, a support period, or security update delivery.
Practical conclusion: build to CRA Annex I and map the AI-specific threat vectors into it. This satisfies both.
Documentation
Both regulations require technical documentation. The content overlaps significantly. The structure and the recipient do not.
| Documentation element | AI Act Annex IV | CRA Annex VII |
|---|---|---|
| General product description | Required | Required |
| Intended purpose | Required | Required |
| System architecture | Required | Required |
| Development methodology | Required | Required |
| Training data description | Required | Not applicable |
| Data governance practices | Required, Article 10 | Not applicable |
| Risk management system | Required, Article 9 | Cybersecurity risk assessment required |
| Testing and validation results | Required | Required |
| Accuracy metrics | Required | Not applicable |
| Human oversight measures | Required, Article 14 | Not applicable |
| SBOM | Not required | Required, Annex I |
| Vulnerability handling process | Not required | Required |
| Support period | Not required | Required |
| Standards applied | Required | Required |
| Declaration of conformity | Required, Article 47 | Required |
Neither document is a subset of the other. Annex IV carries the AI-specific content: training data, accuracy, human oversight, fundamental rights. CRA Annex VII carries the product security content: SBOM, vulnerability handling, support period.
The overlapping sections, product description, architecture, development methodology, testing, and standards, should be maintained once and rendered into both formats rather than drafted twice.
The SBOM Question in CRA
The CRA requires a software bill of materials in a commonly used machine-readable format covering at least top-level dependencies. The AI Act does not require an SBOM.
However, an SBOM produced for CRA purposes has direct value for AI Act compliance. Annex IV requires a description of the system architecture and the software components used. A current SBOM answers part of that requirement and does so in a form a market surveillance authority can process.
Where an AI system is also a product with digital elements, the CRA SBOM should cover the AI components, including model files, inference libraries, and any third-party models integrated into the product.
Where CRA and EU AI Act Obligations Diverge
Reporting: Two Clocks, Two Bodies
This is the area where consolidation of CRA and EU AI Act requirements is not possible and where organisations are most likely to fail.
| Feature | CRA Article 14 | AI Act Article 73 | AI Act Article 55 (GPAI) |
|---|---|---|---|
| Trigger | Actively exploited vulnerability or severe incident | Serious incident involving high-risk AI system | Serious incident involving systemic risk GPAI model |
| First deadline | 24 hours | 15 days | Without undue delay |
| Second stage | 72 hours | Not applicable | Not applicable |
| Final report | 14 days after corrective measure available | Not separately specified | Not separately specified |
| Recipient | Coordinating CSIRT and ENISA via SRP | National market surveillance authority | AI Office |
| Channel | Single Reporting Platform | National authority channel | AI Office |
| In force since | 11 September 2026 | 2 December 2027 for Annex III | 2 August 2025 |
A single event can trigger both. An actively exploited vulnerability in an AI-powered product that causes serious harm is a CRA Article 14 report within 24 hours and an AI Act Article 73 report within 15 days, to different bodies through different channels.
The reports are not interchangeable. Filing on the SRP does not discharge the AI Act obligation. Notifying a market surveillance authority does not discharge the CRA obligation.
Practical conclusion: one incident response process with two output paths, triggered by a single assessment. The 24-hour CRA clock is the binding constraint, so the process must be designed around it.
Conformity Assessment: CRA and EU AI Act
Both regulations require conformity assessment before market placement, and they are separate exercises with separate classification schemes.
| Feature | AI Act | CRA |
|---|---|---|
| Classification basis | Risk tier under Article 6 | Product class under Annex III |
| Default route | Internal control, Annex VI | Manufacturer self-assessment |
| Third-party route | Notified body for certain biometric and Annex I systems | Notified body for Important Class II and Critical |
| Presumption of conformity | Harmonised standards under Article 40 | Harmonised standards |
| CE marking | Article 48 | Required |
| Declaration of conformity | Article 47 | Required |
| Registration | EU database, Article 49 | Not required |
A product can be default-tier under the CRA and high-risk under the AI Act, or Important Class II under the CRA and minimal risk under the AI Act. The classifications are independent.
Where both require notified body involvement, the same notified body may be able to perform both assessments if designated under both regulations. Capacity is finite and demand will concentrate in 2027.
Support Periods and Lifecycle in CRA and EU AI Act
The CRA requires manufacturers to provide security updates for a support period, generally a minimum of five years, and to make the support period visible at the point of purchase.
The AI Act has no equivalent support period obligation. It requires post-market monitoring under Article 72 and retention of technical documentation for ten years under Article 18, but does not require the manufacturer to keep issuing security updates for a defined period.
This is a genuine gap rather than an overlap. An AI system that is also a product with digital elements carries the CRA support obligation. An AI system outside CRA scope, such as a medical device AI, does not, though sector legislation may impose an equivalent.
CRA and EU AI Act: Enforcement and Penalties
The CRA and EU AI Act regulations have separate enforcement architectures and separate penalty ceilings. Both can be applied to the same organisation for the same product.
| Infringement | Regulation | Maximum penalty |
|---|---|---|
| Prohibited AI practices | AI Act Article 99(3) | €35m or 7% of worldwide turnover |
| High-risk AI or GPAI obligations | AI Act Article 99(4) | €15m or 3% of worldwide turnover |
| CRA Annex I essential requirements | CRA | €15m or 2.5% of worldwide turnover |
| Other CRA manufacturer obligations, including reporting | CRA | €10m or 2% of worldwide turnover |
| Misleading information to authorities | Both | AI Act €7.5m or 1%; CRA €5m or 1% |
Enforcement bodies differ. CRA enforcement sits with national market surveillance authorities designated under that regulation. AI Act enforcement for high-risk systems sits with national market surveillance authorities designated under the AI Act, and for GPAI models with the AI Office. These may or may not be the same national body depending on member state designation.
Both CRA and EU AI Act regulations permit market withdrawal and recall. For a software product, a withdrawal order under either regulation is a more serious commercial event than the fine.
The Combined CRA and EU AI Act Timeline
| Date | Obligation | Regulation |
|---|---|---|
| 2 February 2025 | Prohibited practices, AI literacy | AI Act |
| 2 August 2025 | GPAI obligations, GPAI authorised representative | AI Act |
| 11 June 2026 | Member states designate CRA authorities and notified bodies | CRA |
| 2 August 2026 | AI Office enforcement powers, Article 50 transparency | AI Act |
| 11 September 2026 | CRA reporting obligations, Single Reporting Platform live | CRA |
| 2 December 2026 | Article 50(2) synthetic content marking for existing systems | AI Act |
| 2 December 2027 | Annex III high-risk AI obligations | AI Act |
| 11 December 2027 | CRA full application, Annex I, SBOM, CE marking | CRA |
| 2 August 2028 | Annex I product-embedded high-risk AI obligations | AI Act |
December 2027 is the convergence point. Organisations subject to both face full CRA application and Annex III high-risk AI obligations within nine days of each other.
Building One Programme, Not Two
The efficient approach treats the shared facts as a single record and the obligations as views onto it.
What can be built once
- Security architecture to CRA Annex I, with AI-specific threat vectors mapped in, satisfying AI Act Article 15.
- SBOM covering all components including AI models and inference libraries, serving CRA Annex I and supporting AI Act Annex IV architecture documentation.
- Product description, architecture documentation, development methodology, and testing records, maintained once and rendered into both Annex IV and CRA Annex VII formats.
- A single incident detection and assessment process, terminating in two reporting paths on different clocks.
- Supplier contract requirements covering SBOM provision, vulnerability notification, and, for AI components, the Article 53 downstream information a GPAI provider must supply.
What must be built separately
- Risk management system under AI Act Article 9, which addresses risks to health, safety, and fundamental rights rather than cybersecurity risk.
- Data governance under Article 10, covering training data quality and bias examination.
- Human oversight design under Article 14.
- Fundamental Rights Impact Assessment under Article 27 where the deployer falls within scope.
- Vulnerability handling process and support period commitments under CRA Annex I Part II.
- Conformity assessment for each regulation against its own classification.
- Reporting submissions, which run to different bodies on different clocks and cannot be consolidated.
Do the CRA and the EU AI Act apply to the same products?
Frequently. The CRA applies to products with digital elements placed on the EU market. The AI Act applies to AI systems placed on the market or put into service. An AI-powered software product or connected device typically falls within both, and both sets of obligations apply in full.
Does complying with the CRA satisfy the AI Act cybersecurity requirement?
Substantially. A security programme built to CRA Annex I will cover most of AI Act Article 15, provided AI-specific threat vectors including data poisoning, model poisoning, and adversarial inputs are explicitly addressed. The reverse is not true: Article 15 does not require a vulnerability handling process, a support period, or security update delivery.
Can we use one technical documentation set for both?
Not one document, but one underlying record. The overlapping content, product description, architecture, development methodology, testing results, and standards applied, should be maintained once and rendered into both AI Act Annex IV and CRA Annex VII formats. The AI-specific content in Annex IV and the security-specific content in CRA Annex VII have no counterpart in the other regulation.
Does the AI Act require an SBOM?
If an incident triggers both regulations, do we file once?
No. CRA reporting goes to the coordinating CSIRT and ENISA through the Single Reporting Platform within 24 hours. AI Act serious incident reporting goes to the national market surveillance authority within 15 days for high-risk systems, or to the AI Office for systemic risk GPAI models. The channels, recipients, and deadlines are separate and neither filing discharges the other.
Are medical devices with AI subject to the CRA?
No. Medical devices covered by the MDR and IVDR are excluded from the CRA, which defers to the sector cybersecurity regime. They remain fully within the AI Act through the Annex I product safety route to high-risk classification.
Does the CRA apply to GPAI models?
Where the model is placed on the EU market as a product with digital elements, yes. A model made available via API as a commercial product is a product with digital elements. It is simultaneously subject to Chapter V of the AI Act. Both regimes apply.
Which conformity assessment do we do first?
They are independent exercises and neither depends on the other. In practice, sequence by deadline and by notified body availability. Where both require notified body involvement, check whether a single body is designated under both regulations.
Do UK and US companies face both regulations?
Yes, where products are placed on the EU market. Both regulations follow market placement rather than establishment. A UK or US company selling AI-powered software into the EU is a CRA manufacturer and an AI Act provider simultaneously.
What is the practical first step for a company subject to both?
Determine your classification under each regulation separately: risk tier under AI Act Article 6, and product class under CRA Annex III. The two classifications drive different obligation sets and different assessment routes, and neither can be inferred from the other.
