EU Cyber Resilience Act
Products with digital elements: hardware and software that connect, directly or indirectly, to another device or network. Essential cybersecurity requirements, a support period with security updates, vulnerability handling, reporting of actively exploited vulnerabilities and severe incidents, technical documentation, conformity assessment and CE marking.
licensed text The requirement text and the evidence an inspector accepts sit behind this regime, licensed from a human-verified corpus.
What it expects in the file
- Technical file
The technical documentation: design, drawings, bill of materials, the standards applied, the conformity assessment route, and the evidence that the requirements are met. Kept for the retention period the regime sets, typically ten years from the last unit placed on the market. - Declaration of conformity
The EU or UK declaration of conformity (or the food-contact declaration of compliance), signed by the manufacturer, naming the product, the legislation and the standards, and the notified or approved body where one was involved. - Risk assessment
The documented hazard identification and risk assessment for the product across its lifecycle, updated when the design, the use or the field data changes. - Test reports
Test reports from an accredited or accepted laboratory against the standards the technical file names, tied to the exact model and revision tested. - Labelling and instructions
Markings on the product and packaging (conformity mark, identification, warnings, manufacturer and importer details) and the instructions and safety information in the language of the market. - Cybersecurity documentation
The software bill of materials, the vulnerability handling and disclosure policy, the stated support period, and the secure update mechanism, as the connected-product rules expect.
Duties that continue after sale
- Incident reporting
Notify the authority when a product has caused, or could cause, an accident, injury or serious incident, through the channel the regime names (the Safety Business Gateway, the MHRA, the FDA, SaferProducts.gov) and within its clock. - Security updates and vulnerability handling
Provide security updates for the stated support period, run a coordinated vulnerability disclosure process, and report actively exploited vulnerabilities and severe incidents within the reporting clock. - Traceability records
Keep the records that identify which batch went to which customer, and the identification on the product that lets a unit be traced back, for the retention period the regime sets.
Every control, with the requirement text
24 controls. Requirement text and evidence artefacts from a human-verified corpus. Data licensed to Conformity Sheet by The Art of Service Pty Ltd, revocable, non-transferable. Framework page: compliance.theartofservice.com/frameworks/eu-cra.
CRA: 24 controls
CRA Art.1 Subject matter (Article 1)Article 1 establishes the Regulation's subject matter: horizontal rules for placing products with digital elements (PDEs) on the Union market with cybersecurity requirements, conformity assessment and market surveillance obligations, and obligations on economic operators (manufacturers, importers, distributors, authorised representatives) and on open-source software stewards.
Common gap: Treating CRA as sectoral cybersecurity legislation - it is HORIZONTAL covering all PDEs not otherwise sector-regulated
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.11, 12 Relationship with general product safety and AI Act (Articles 11-12)Article 11 derogates from the General Product Safety Regulation (GPSR, (EU) 2023/988) for products covered by the CRA on the cybersecurity dimension (CRA takes precedence). Article 12 coordinates with the AI Act (Regulation (EU) 2024/1689): for high-risk AI systems that are also PDEs, compliance with the CRA essential cybersecurity requirements counts toward the AI Act Article 15 accuracy/robustness/cybersecurity obligation (presumption of conformity).
Common gap: Dual cybersecurity compliance paths for the same high-risk AI system PDE (Article 12 allows a single CRA path)
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.13, Annex I Manufacturer obligations and essential requirements (Article 13 + Annex I)Article 13 imposes the central manufacturer obligations: (1) design, develop and produce the PDE to ensure an appropriate level of cybersecurity based on the cybersecurity risk assessment in Article 13(2); (2) Article 13(6) due diligence on third-party components integrated in the PDE including FOSS dependencies; (3) Article 13(8) documented support period (default 5 years, adjustable per product lifecycle and category) during which security updates are provided free of charge, automatically by default, and separately from feature updates; (4) Article 13(12) information and instructions to users (Annex II); (5) Article 13(15)-(16) cooperation with market surveillance. Annex I Part I sets the essential cybersecurity requirements (secure by default, secure communication, data minimisation, access control, no exploitable known vulnerabilities at time of placing on the market, etc.). Annex I Part II sets the vulnerability handling requirements (vulnerability disclosure policy, SBOM availability where relevant, security updates throughout the support period, coordination on disclosed vulnerabilities).
Common gap: No documented support period or support-period shorter than the product's reasonably expected lifecycle
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.14, 16 Reporting obligations and the single reporting platform (Articles 14 and 16)Article 14 imposes a layered reporting regime channelled through the Article 16 single reporting platform operated by ENISA and CSIRTs: (1) 24-hour early warning to ENISA and to the CSIRT designated as the coordinator notifying of an actively exploited vulnerability or severe incident; (2) 72-hour notification update; (3) Final report within 14 days (or one month for severe incidents). Article 14(8) requires the manufacturer to notify users without undue delay of any actively exploited vulnerability and any severe incident impacting the security of the PDE, including instructions on corrective measures available to users. Article 14(10)-(11) provides for voluntary notification of other vulnerabilities and incidents, with protection of reporting persons.
Common gap: No 24/7 capability to meet 24-hour early warning for actively exploited vulnerabilities
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.18 Authorised representatives for non-EU manufacturers (Article 18)Article 18 requires non-EU manufacturers placing PDEs on the Union market to appoint, by written mandate, an authorised representative established in the Union. The authorised representative carries enumerated tasks: keep the EU declaration of conformity and the technical documentation at the disposal of market surveillance for 10 years, cooperate with market surveillance, terminate the mandate if the manufacturer acts contrary to the Regulation and inform competent authorities.
Common gap: Non-EU manufacturer placing PDEs on the EU market without an authorised representative
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.19, 20 Obligations of importers and distributors (Articles 19-20)Article 19 requires importers to verify before placing a PDE on the market that the manufacturer has carried out the conformity assessment procedure, that CE marking and EU declaration of conformity are present, that technical documentation is available, that the importer's contact details are on the product or its packaging, and that documentation is available to market surveillance for 10 years. Article 20 imposes parallel due-care obligations on distributors when making PDEs available, including verifying that CE marking and required documentation are present, and acting with due care in storage and transport.
Common gap: Importing PDEs without verifying CE marking and EU declaration of conformity
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.2 Scope - Products with Digital Elements (Article 2)Article 2 sets the scope: the Regulation applies to PDEs whose intended purpose or reasonably foreseeable use includes a direct or indirect logical or physical data connection to a device or network. Carve-outs include: products covered by sector-specific Union law (medical devices under MDR/IVDR, motor vehicles under (EU) 2019/2144, civil aviation under (EU) 2018/1139, marine equipment); spare parts; products in development not yet placed on the market; pure services. The CRA does NOT apply to non-commercial open-source software (Recital 19 + Article 24 boundary on FOSS stewards).
Common gap: Applying CRA to a medical-device PDE that is in fact governed by MDR cybersecurity requirements (sectoral carve-out applies)
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.21, 22 When importers and distributors are treated as manufacturers (Articles 21-22)Article 21 provides that an importer or distributor is considered to be the manufacturer for the purposes of the Regulation, and is subject to the corresponding obligations, where the importer or distributor places a PDE on the market under their own name or trademark, or substantially modifies a PDE already placed on the market. Article 22 covers other cases where manufacturer obligations apply (open-source contributions integrated into a commercial PDE by the manufacturer).
Common gap: Substantial modification of a placed-on-market PDE without re-running conformity assessment as the new manufacturer
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.23 Identification of economic operators (Article 23)Article 23 requires economic operators to identify, upon request from a market surveillance authority, any other economic operator that supplied them with a PDE and to whom they have supplied a PDE, for a period of 10 years from the date when the operator was supplied or supplied the PDE.
Common gap: No 10-year supply-chain records
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.24, 25 Open-source software stewards (Articles 24-25)Article 24 introduces the new 'open-source software steward' role: a legal person, other than a manufacturer, that has the purpose or objective of systematically providing support on a sustained basis for the development of specific products with digital elements qualifying as free and open-source software, that are intended for commercial activities, and ensures the viability of those products. Stewards have a lighter compliance regime than manufacturers including a documented cybersecurity policy, cooperation with market surveillance, and a vulnerability-handling process aligned with Annex I Part II. Article 25 enables voluntary security attestation of FOSS to facilitate due diligence by manufacturers integrating FOSS components.
Common gap: FOSS steward without a documented cybersecurity policy
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.27, 28 Presumption of conformity and EU declaration of conformity (Articles 27-28)Article 27 establishes a presumption of conformity for PDEs that conform with: (a) harmonised standards or parts thereof published in the Official Journal; (b) European cybersecurity certification schemes adopted under (EU) 2019/881 designating the schemes as offering presumption of conformity with all or part of the essential requirements. Article 28 requires the manufacturer to draw up a written EU declaration of conformity attesting that the demonstrated fulfilment of the essential requirements has been carried out. Annex V sets the content of the EU declaration.
Common gap: EU declaration of conformity missing Annex V required content
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.29, 30 CE marking (Articles 29-30)Article 29 sets the general principles of the CE marking on PDEs (Regulation (EC) 765/2008 framework). Article 30 sets the affixing rules: the CE marking is affixed visibly, legibly and indelibly to the PDE; where the nature of the product does not allow it, the CE marking is affixed to the packaging and the accompanying documents. Where a notified body is involved (Module B+C or Module H per Article 32) the notified body's identification number follows the CE marking.
Common gap: CE marking absent or not affixed visibly/legibly/indelibly
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.3 Definitions (Article 3)Article 3 supplies the definitions used throughout the Regulation. Key definitions include: 'product with digital elements' (a software or hardware product and its remote data processing solutions, including its components placed on the market separately); 'remote data processing'; 'manufacturer'; 'authorised representative'; 'importer'; 'distributor'; 'placing on the market' vs 'making available on the market'; 'substantial modification' (which can re-trigger manufacturer status under Article 21-22); 'critical product with digital elements' (Article 7 + Annex IV); 'important product with digital elements' (Article 6 + Annex III); 'open-source software steward'; 'severe incident'; 'actively exploited vulnerability'.
Common gap: No documented definition of 'substantial modification' creating ambiguity over when an importer/distributor becomes a manufacturer
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.31 Technical documentation (Article 31 + Annex VII)Article 31 requires the manufacturer to draw up the technical documentation for the PDE before it is placed on the market and to keep it up to date during the support period. The technical documentation contains the items in Annex VII: general description, design and manufacturing of the product including risk assessment, system architecture, list of harmonised standards applied, copy of the EU declaration of conformity, vulnerability-handling process, software bill of materials where appropriate, support-period documentation. The technical documentation must be kept available for 10 years after placing on the market. Annex VI permits simplified technical documentation for microenterprises and small enterprises.
Common gap: Technical documentation lacking Annex VII items (e.g. no SBOM, no risk assessment)
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.32 Conformity assessment procedures (Article 32)Article 32 sets the conformity assessment routes: (1) Default PDE - Module A (internal production control - self-assessment by the manufacturer); (2) Important PDE Class I (Annex III Class I) - Module A if the manufacturer applies harmonised standards or European cybersecurity certification, otherwise Module B+C (EU type-examination + conformity to type) or Module H (full quality assurance) by a notified body; (3) Important PDE Class II (Annex III Class II) - Module B+C or Module H mandatory by a notified body; (4) Critical PDE (Annex IV) - mandatory European cybersecurity certification at assurance level 'substantial' or higher under (EU) 2019/881.
Common gap: Self-assessment (Module A) for an Important Class II or Critical PDE
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.33 SME and microenterprise support measures (Article 33)Article 33 requires Member States and the Commission to put in place support measures for microenterprises and SMEs, including regulatory sandboxes, simplified technical documentation under Annex VI, conformity-assessment-fee discounts where notified bodies are used, awareness programmes, and one-stop shops at national level.
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.35, 36, 37 Notification of conformity assessment bodies and notifying authority requirements (Articles 35-37)Article 35 requires Member States to notify the Commission and the other Member States of the bodies authorised to carry out third-party conformity-assessment tasks under the Regulation. Article 36 sets the requirements for notifying authorities (legally distinct from notified bodies, no conflict of interest). Article 37 sets the substantive requirements for notified bodies (independence, competence, no conflict of interest, accreditation by the national accreditation body, professional liability insurance).
Common gap: Engagement of a body that is not a CRA-notified body for Module B+C / Module H assessments
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.39, 41 Operational requirements for notified bodies and subsidiaries (Articles 39 and 41)Article 39 sets the operational requirements for notified bodies (impartiality, transparency, fees, conflict-of-interest management, ongoing competence). Article 41 governs subsidiaries of and subcontracting by notified bodies: the notified body retains full responsibility for the tasks performed by subcontractors and subsidiaries.
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.52 Market surveillance and control (Article 52)Article 52 designates market surveillance authorities under Regulation (EU) 2019/1020 and gives them the standard market-surveillance powers (inspect, request information, take samples, demand documentation). Member States may designate the ENISA or the national CSIRT as the market surveillance authority for the cybersecurity dimension.
Common gap: Engagement only with traditional product-safety MSAs where the cybersecurity MSA is ENISA or the national CSIRT
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.54, 55 Significant cybersecurity risk procedure and Union safeguard (Articles 54-55)Article 54 sets the procedure at national level concerning PDEs presenting a significant cybersecurity risk: the market surveillance authority can order corrective action, withdrawal or recall from the market within a reasonable period. Article 55 sets the Union safeguard procedure where Member States disagree on the existence of the risk or the measure taken.
Common gap: No documented corrective-action / withdrawal capability
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.61, 62, 63 Delegation, committee procedure and confidentiality (Articles 61-63)Article 61 governs the exercise of the delegation of power (to amend Annex III/Annex IV product lists, the essential requirements, the conformity-assessment thresholds). Article 62 sets the committee procedure. Article 63 imposes confidentiality on information acquired in carrying out tasks under the Regulation, with carve-outs for information sharing with market surveillance, CSIRTs and other competent authorities.
Common gap: No tracking of delegated-act updates causing reclassification of PDEs from default to Important/Critical
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.64 Penalties (Article 64)Article 64 establishes penalties: (a) breach of essential cybersecurity requirements (Annex I) and Article 13/14 manufacturer obligations and reporting - administrative fines up to EUR 15 million or 2.5% of worldwide annual turnover, whichever is higher; (b) breach of other obligations - administrative fines up to EUR 10 million or 2% of worldwide annual turnover, whichever is higher; (c) supply of incorrect, incomplete or misleading information to notified bodies or market surveillance authorities - administrative fines up to EUR 5 million or 1% of worldwide annual turnover, whichever is higher.
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.69, 70, 71 Transitional provisions, evaluation and entry into force (Articles 69-71)Article 69 sets the transitional provisions: PDEs placed on the market before 11 December 2027 are subject to the Regulation only where they are subject to a substantial modification after that date. Article 70 requires the Commission to evaluate and report on the Regulation by 11 December 2030 and every 4 years thereafter. Article 71 sets the entry into force (twentieth day after publication in OJ - 10 December 2024) and the application dates: most provisions apply from 11 December 2027 (36-month transition); the Article 14 reporting regime applies earlier from 11 September 2026; the notified-body provisions apply earlier from 11 June 2026.
Common gap: Compliance plan that treats 11 December 2027 as the only date
EU Cyber Resilience Act on compliance.theartofservice.com
CRA Art.6, 7 Important and critical products with digital elements (Articles 6-7)Article 6 + Annex III defines Important PDEs (Class I and Class II) including identity-management systems, password managers, browser plug-ins, operating systems, microcontrollers with security functionality, routers/modems/switches, network management systems, and similar critical infrastructure components. Article 7 + Annex IV defines Critical PDEs including hardware devices with security boxes, smart-meter gateways with cybersecurity functionality, and smartcards with security elements. Important PDEs trigger third-party conformity assessment by a notified body (Module B+C or Module H per Article 32). Critical PDEs require mandatory European cybersecurity certification under (EU) 2019/881.
Common gap: Self-certification (Module A) for a product that is in fact an Important or Critical PDE
EU Cyber Resilience Act on compliance.theartofservice.com
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