The rule pack
EU Cyber Resilience Act requirement pack 0.4.0 · 28 requirements · Regulation (EU) 2024/2847
Evidence expectations, model 1.1.0. No harmonised standard for the Cyber Resilience Act is cited in the Official Journal yet. These expectations are Vandorisk's reading of what an assessor will ask to see, written against the CEN/CENELEC enquiry drafts prEN 40000-1-2 (principles, risk management and lifecycle activities) and prEN 40000-1-3 (vulnerability handling), the regulation itself, and the Commission guidance C(2026) 5252. Every expectation names its source; draft text is cited by clause and never reproduced. They shape what goes into the technical file and how it is read. They do not decide whether a Declaration of Conformity may issue — that gate stays on the requirement answers.
- Regulation (EU) 2024/2847 — Cyber Resilience Act — Annex I essential requirements, Articles 13, 14, 28–30, Annex VII. In force. Reporting duties apply from 11 September 2026; full application 11 December 2027.
- prEN 40000-1-2:2025 — Cybersecurity requirements for products with digital elements — Part 1-2: Principles for cyber resilience. CEN/CENELEC enquiry draft, October 2025 (CEN/CLC/JTC 13). Not cited in the Official Journal; confers no presumption of conformity. Annex C maps its clauses to Annex I.
- prEN 40000-1-3:2025 — Cybersecurity requirements for products with digital elements — Part 1-3: Vulnerability handling. CEN/CENELEC enquiry draft, December 2025 (CEN/CLC/JTC 13). Not cited in the Official Journal; confers no presumption of conformity. Annex ZA maps its subclauses to Annex I Part II.
- prEN 40000-1-1 — Cybersecurity requirements for products with digital elements — Part 1-1: Vocabulary. CEN/CENELEC enquiry draft. Terms used here follow it where they differ from everyday usage; the regulation's definitions prevail.
- C(2026) 5252 — Commission guidance on the application of Regulation (EU) 2024/2847 (27 July 2026). Approved draft guidance. Paragraph references are to the annex.
Each expectation names where its evidence prints — an element of the Annex VII technical file, or Annex II where the draft’s own output is the information and instructions to the user (Annex VII(1) general description of the product, Annex VII(1)(c) photographs or illustrations, Annex VII(2) design, development and production processes, and so on) — and the draft clause, article or guidance paragraph it rests on.
Every rule this product evaluates, with its citation. Nothing on this page is generated at answer time — the product is deterministic over this data, and this page is rendered from the same file the engine reads. If the pack changes, this page changes with it, and the changelog below says what moved and when.
The same data, machine-readable and with the changelog attached, is served at /api/pack— fetch it, keep a copy, and diff it against a later version. The citation index is the part a reviewer clears fastest: one table mapping each requirement to the provision it implements and whether Article 13(3) permits excluding it.
On this page: citation index · risk assessment · the full pack · conformity routes · classification · changelog
What this pack cites
- Regulation (EU) 2024/2847 (the Cyber Resilience Act) — official text on EUR-Lex. The regulation is authoritative; this pack cites it and does not replace it.
- Commission Implementing Regulation (EU) 2025/2392 of 28 November 2025 — Binding technical descriptions of the Annex III (Class I/II) and Annex IV categories, adopted under Art. 7(4); in force since 21 December 2025. Decision-tree item scoping follows its Annex I/II descriptions.
- C(2026) 5252 (2026-07-27), Commission guidance on the application of Regulation (EU) 2024/2847 (Cyber Resilience Act) — C(2026) 5252 approves the CONTENT of a draft Communication; the guidance is formally adopted only once all language versions are available. Paragraph references may shift in the adopted text — verify before relying on them. It does not change the application dates: Chapter IV from 11 June 2026, Article 14 reporting from 11 September 2026, full application from 11 December 2027.
How to read the ids and item strings: Annex I Part I requirements lettered against the final OJ text (2)(a)-(m) and displayed in official order; requirement ids (I.2, I.3a-k, I.3m) are STABLE internal keys kept for data compatibility and intentionally do not mirror the official letters — legalRef is authoritative. Annex III/IV category item strings are verbatim from the OJ, omitting only footnote markers and institutional citation tails ('of the European Parliament and of the Council'). Category scoping notes come from Implementing Regulation (EU) 2025/2392. naAllowed marks the requirements for which Art. 13(3) permits a documented non-applicability determination (Annex I Part I(2) only). Version every assessment against packVersion.
Citation index
All 28requirements in one table: internal id, title, the provision it implements, whether it is a property of the product or of the manufacturer’s process, and whether Article 13(3) permits a documented non-applicability determination. Ids link to the full text below; each row is addressable (for example #req-I.2) so a review can cite specific rows.
| Id | Requirement | Provision | Type | Art. 13(3) |
|---|---|---|---|---|
| Annex I Part I — Product security properties | ||||
| I.1 | Appropriate cybersecurity based on risk | Annex I Part I(1) | Product | Always applies |
| I.2 | No known exploitable vulnerabilities at delivery | Annex I Part I(2)(a) | Product | May be excluded with a documented justification |
| I.3a | Secure-by-default & resettable | Annex I Part I(2)(b) | Product | May be excluded with a documented justification |
| I.3k | Addressable via security updates | Annex I Part I(2)(c) | Product | May be excluded with a documented justification † |
| I.3b | Access control / authentication | Annex I Part I(2)(d) | Product | May be excluded with a documented justification |
| I.3c | Confidentiality (encryption) | Annex I Part I(2)(e) | Product | May be excluded with a documented justification |
| I.3d | Integrity & corruption reporting | Annex I Part I(2)(f) | Product | May be excluded with a documented justification |
| I.3e | Data minimisation | Annex I Part I(2)(g) | Product | May be excluded with a documented justification |
| I.3f | Availability & DoS resilience | Annex I Part I(2)(h) | Product | May be excluded with a documented justification |
| I.3g | Minimise impact on other devices/networks | Annex I Part I(2)(i) | Product | May be excluded with a documented justification |
| I.3h | Limit attack surface | Annex I Part I(2)(j) | Product | May be excluded with a documented justification |
| I.3i | Exploitation mitigation | Annex I Part I(2)(k) | Product | May be excluded with a documented justification |
| I.3j | Security logging / monitoring (user opt-out) | Annex I Part I(2)(l) | Product | May be excluded with a documented justification † |
| I.3m | Secure permanent data removal & transfer | Annex I Part I(2)(m) | Product | May be excluded with a documented justification † |
| Annex I Part II — Vulnerability handling | ||||
| II.1 | SBOM & vulnerability identification | Annex I Part II(1) | Process | Always applies |
| II.2 | Remediate without delay; ship security fixes separately | Annex I Part II(2) | Process | Always applies |
| II.3 | Regular security testing | Annex I Part II(3) | Process | Always applies |
| II.4 | Disclose fixed vulnerabilities | Annex I Part II(4) | Process | Always applies |
| II.5 | Coordinated vulnerability disclosure policy | Annex I Part II(5) | Process | Always applies |
| II.6 | Facilitate info-sharing & reporting contact | Annex I Part II(6) | Process | Always applies |
| II.7 | Secure update distribution | Annex I Part II(7) | Process | Always applies |
| II.8 | Free & timely patches with advisories | Annex I Part II(8) | Process | Always applies |
| Process & lifecycle obligations (Articles 13 & 14) | ||||
| P.1 | Third-party & open-source component due diligence | Article 13(5)-(6) | Process | Always applies |
| P.2 | Vulnerability handling for the whole support period | Article 13(8) | Process | Always applies |
| P.3 | Security-update availability retention | Article 13(9) | Process | Always applies |
| P.4 | Reporting of actively exploited vulnerabilities & severe incidents | Article 14 | Process | Always applies |
| P.5 | Support-period end date disclosed, expiry notified | Article 13(19) | Process | Always applies |
| P.6 | CE marking affixed correctly | Articles 29–30 | Process | Always applies |
† This requirement bundles limbs the regulation qualifies individually (“where applicable”); the per-limb applicability, including the limbs that remain unconditional, is in the full text below.
The risk assessment the pack builds on
Article 13(2)-(4),(7) · mandatory
Foundational. Must be documented, included in the technical file, updated over the support period, and used to decide the applicability of the Annex I Part I(2) requirements (justify any marked not applicable, Art. 13(4)). For Part II, the risk assessment informs HOW the requirements are applied — it cannot disapply them (Art. 13(3)).
- Intended purposeArt. 3(23)
- Reasonably foreseeable use & misuseArt. 3(24)-(25)
- Conditions of use / operational environmentArt. 13(3)
- Assets to be protectedArt. 13(3)
- Expected time in useArt. 13(3),(8)
- Threats & risk analysisArt. 13(2)
Annex I Part I — Product security properties
I.1 — Appropriate cybersecurity based on riskAnnex I Part I(1)
Design, develop and produce the product to ensure an appropriate level of cybersecurity based on the risks, as informed by your risk assessment.
How to satisfy it: Show your security measures trace to the risks identified in the risk assessment.
What an assessor will ask for — Show that the product's security measures follow from an assessment of its risks: the risk work exists, is written down, and the product's own security requirements and design trace back to it.
- Product context record Documentation · Annex VII(1)
Describe the product the way the risk work sees it: its intended purpose and reasonably foreseeable use, the functions it provides, the environment it operates in, an architecture overview with its interfaces and dependencies (including any remote data processing), and who its users are.
Check: The record exists and covers each of those elements; anything the risk assessment relies on is in it. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §6.2.3–6.2.5 (product context: requirement, output, assessment criteria); Annex VII(1)(a)–(b). - Risk acceptance criteria and risk methodology Documentation · Annex VII(3)
State how risk is defined and measured for this product and what level of risk you accept, taking into account regulatory and contractual factors, the nature of the risks, the users, the product itself, and the state of the art.
Check: Both exist; the criteria are justified for the product and the methodology is applied consistently across its lifecycle. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §6.3.3–6.3.5; Art. 13(2). - Asset, objective and threat lists Documentation · Annex VII(3)
List the assets the product handles or affects, with the security objective for each, and for every asset the threats to it: what is targeted, which objective is compromised, and how.
Check: The lists exist and are complete enough that every listed asset has its threats. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §6.4.2.4 and §6.4.3.4, with their assessment criteria; Art. 13(2). - Risk estimates and evaluation Documentation · Annex VII(3)
For each threat, the estimated likelihood and magnitude of loss, the resulting risk, and its evaluation against your acceptance criteria — including the justification for every residual risk you accept.
Check: The list exists and follows the declared methodology; each accepted residual risk carries a justification consistent with the criteria. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §6.4.4.4–6.4.5.5; Art. 13(2). - Risk treatment decisions Documentation · Annex VII(3)
For each risk, the treatment chosen — avoid, mitigate, accept or transfer, in that order of preference — with its justification; and where an inherent risk is accepted, what the user is told and which mitigation you recommend.
Check: A decision with justification exists per risk and follows the treatment methodology. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §6.5.3–6.5.5; Annex I Part I(2), chapeau. - Risk information for users and integrators Documentation · Annex II
The residual risks, the mitigations you recommend, the assumptions about the operating context, and what you expect of users and downstream integrators — in the form they actually receive it, usually inside the information and instructions to the user.
Check: The documentation exists and gives the stakeholder enough to mitigate the risk. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §6.6.3–6.6.5; Annex II. - Risk review regularity and triggered updates Process · Annex VII(3)
How often the risk management is reviewed and why that regularity fits the product; the triggers for an unscheduled review (threat-landscape change, an incident, component obsolescence); and the updated documentation a triggered review produced.
Check: The regularity is determined and justified; where a review was triggered, updated risk documentation exists. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §6.7.3–6.7.5; Annex I Part II(3) (regular reviews). - Product cybersecurity plan Documentation · Annex VII(2)
The plan for the security activities across the product's lifecycle: acceptance criteria and their rationale, the methodologies used, the support period and decommissioning plan, the recurring test-and-review schedule, update and component-obsolescence planning, and vulnerability response timescales.
Check: The plan exists, is maintained, and contains each of those elements. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.2.3–7.2.5. - Product cybersecurity requirements Documentation · Annex VII(2)
The security requirements you derived for this product from the risk work and the regulation, each with its applicability, its technical specification, and the controls selected to fulfil it.
Check: Documented, traceable to the risk assessment and treatment, and reviewed when the inputs change. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.3.3–7.3.5; Annex I Part I(2), chapeau. - Secure implementation and development environment Process · Annex VII(2)
How the product is built securely: the development environment and how it is protected from unauthorised access, the secure coding rules you apply, how cryptographic keys and certificates are managed, and how the vulnerability status of integrated components is confirmed before release.
Check: The outputs of secure implementation exist and meet the requirement — including evidence of the activities you undertook, not only a description of them. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(1) — 'developed', mapped to §7.5 by Annex C Table C.1; prEN 40000-1-2:2025 §7.5.3–7.5.5 (secure implementation: requirement, output including evidence of the outcomes, assessment criteria). - Secure production and distribution controls Process · Annex VII(2)(c)
How the product is protected from tampering between the development team and the user: for software, how build artefacts and the hosting location are protected in transit and at rest and how their authenticity is assured; for hardware, the manufacturing controls over work instructions, installed software, keys and identifiers. Record which of the two applies to this product.
Check: The output of secure production exists, and there is evidence it meets the requirement — the processes and their validation, which is what Annex VII(2)(c) asks for. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(1) — 'produced', mapped to §7.7 by Annex C Table C.1; prEN 40000-1-2:2025 §7.7.2.3–7.7.2.5 (secure digital production) and §7.7.3.3–7.7.3.5 (manufacturing); Annex VII(2)(c).
I.2 — No known exploitable vulnerabilities at deliveryAnnex I Part I(2)(a)
Make the product available on the market without known exploitable vulnerabilities. Art. 3(41) defines an exploitable vulnerability as one an adversary could effectively use under practical operational conditions, so a finding that only reproduces in a lab or simulation does not automatically count. A vulnerability should be regarded as known once it is listed in a public vulnerability database such as the European vulnerability database (Art. 12(2) of Directive (EU) 2022/2555); it may also be known once you learn of it privately through coordinated disclosure or your own testing, or once it is prominently reported in reliable media (guidance §9.2.2 paras 233-234).
How to satisfy it: Screen components before release: the built-in scan queries OSV, which aggregates CVE, GHSA and ecosystem feeds; also monitor the European vulnerability database (EUVD) and vendor advisories. Remediate or justify anything open. Record when you learned of each finding and what your investigation concluded: a report alone does not establish that a vulnerability is exploitable or applicable to your product, and a limited period may pass while you confirm it (guidance C(2026) 5252 s.9.2.2).
What an assessor will ask for — Show that the components in the released version were screened for known vulnerabilities, and that anything found was fixed or shown not to be exploitable in this product.
- Vulnerability screen of the released components Record · Annex VII(6)
The screening result for the components in the released version: which sources were queried (the EU Vulnerability Database, CVE/OSV, vendor advisories), when, and what was found. The built-in SBOM scan produces this; an external scanner's report counts too.
Check: A dated result exists for the released version and names its sources. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(a); prEN 40000-1-2:2025 §6.4.3.2 (known exploitable vulnerabilities as a threat input); §7.6.3 (verifying that known vulnerabilities have been subject to appropriate risk treatment), with the vulnerability-monitoring approach described in §7.6.1 (General — informative); prEN 40000-1-3:2025 §5.4.3 [RCP-2] monitored sources; Guidance C(2026) 5252 §9.2.2 paras 233–234. - Disposition of each open finding Documentation · Annex VII(6)
For every finding still open at release, the reasoning: fixed, not affected (and why), or not exploitable under the product's practical operating conditions — the Art. 3(41) test, applied and written down. The dispositions recorded against the scan in this assessment are this record.
Check: Every open finding carries a documented conclusion; 'not exploitable' is argued, not asserted. Basis: Commission guidance C(2026) 5252. Sources: Art. 3(41); Guidance C(2026) 5252 §9.2.2; prEN 40000-1-3:2025 §5.5.2 [VRF-1] documentation on processing the vulnerability information. - Component due-diligence record Documentation · Annex VII(2)
Evidence that third-party and open-source components were checked against public vulnerability databases when they were selected and when they were integrated, as part of the due diligence on components.
Check: The record shows the check for the components in this release. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.11.3–7.11.5; Art. 13(5).
I.3a — Secure-by-default & resettableAnnex I Part I(2)(b)
Make the product available with a secure by default configuration — unless otherwise agreed between manufacturer and business user for a tailor-made product — including the possibility to reset the product to its original state.
How to satisfy it: Hardened defaults; documented factory reset; record any tailor-made agreement that varies the defaults.
What an assessor will ask for — Show that the shipped configuration is secure without the user doing anything, that the design chose that state deliberately, and that the product can be returned to it.
- Default configuration statement Documentation · Annex VII(2)(a)
What the product's configuration is on first use — enabled interfaces and services, the default-credential policy, the update setting — which of those a user can change, and the reasoning that this state is secure for the intended use.
Check: The design documentation describes the default state and why it is secure. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(b); prEN 40000-1-2:2025 §5.4 (secure by default) and §7.4.3 (the architecture considers §5.4). - Out-of-the-box configuration test Verification · Annex VII(6)
A test on a factory-fresh unit or clean install that records the actual default state and compares it with the statement above.
Check: The observed state matches the documented default configuration. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.6.3–7.6.4 (verification output: test reports). - Reset-to-original-state test Verification · Annex VII(6)
Evidence that the reset function returns the product to its original secure state, including what it clears and what it does not.
Check: The post-reset state equals the shipped default. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(b); prEN 40000-1-2:2025 §5.4. - Agreement with the business user (tailor-made products only) Documentation · Annex VII(2)
Where a different default was agreed with a business user for a tailor-made product, the agreement that records it. Mark this as not applying if the product is not tailor-made.
Check: The agreement exists and names the deviation from the secure default. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(b); prEN 40000-1-2:2025 §6.3.2 (contractual agreements as an input to the risk acceptance criteria).
I.3k — Addressable via security updatesAnnex I Part I(2)(c)
Ensure vulnerabilities can be addressed through security updates, including, where applicable, through automatic security updates installed within an appropriate timeframe and enabled as a default setting with a clear and easy-to-use opt-out mechanism, through the notification of available updates to users, and the option to temporarily postpone them.
How to satisfy it: Secure update mechanism; automatic updates on by default with opt-out where applicable; notify users and allow postponement.
- Vulnerabilities can be addressed through security updates — unconditional. The capability itself is unconditional — a product that cannot be updated cannot meet point (c).
- Automatic security updates, enabled by default — qualified: may be recorded not applicable, with a justification. The CRA qualifies this limb with \u201cwhere applicable\u201d and recital 46 recognises that automatic installation may be inappropriate where an update could disrupt a safety-relevant or continuously operating installation. A machine controller whose operator schedules maintenance windows is the standard example. Record the reason here; it prints into the technical file.
- A clear and easy-to-use opt-out from automatic updates — qualified: may be recorded not applicable, with a justification. Only meaningful where automatic updates apply.
- Users are notified about available updates and can postpone them — qualified: may be recorded not applicable, with a justification. Where updates are installed by an operator rather than pushed, describe how that operator is told.
What an assessor will ask for — Show that vulnerabilities can be fixed in the field: an update mechanism exists, installs automatically by default where the product supports it, tells users, and lets them postpone or opt out.
- Update mechanism description Documentation · Annex VII(2)(a)
How security updates reach the product: the channel, whether automatic installation is enabled by default, how users are told an update is available, and how they opt out or postpone.
Check: The description covers the default setting, notification, opt-out and postponement. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(c); prEN 40000-1-2:2025 §5.4 (updates installed without undue delay, opt-out, postponement) and §7.8.3; prEN 40000-1-3:2025 §5.3.11 [PRE-10] distribution mechanisms. - Update installation test Verification · Annex VII(6)
A test showing an update is delivered and installed through the mechanism, with the default behaviour, the notification and the opt-out or postpone path exercised.
Check: The test records delivery, installation and the user-facing behaviours. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.7.2.5 [RLS-1] evidence of implemented update mechanisms. - Update timeframe policy Process · Annex VII(2)(b)
The timeframe within which security updates are expected to be developed and installed, as planned in the security plan and the vulnerability handling policy.
Check: A target schedule exists and is followed. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.2.3 (vulnerability response planning) and §7.8.3 (without undue delay); prEN 40000-1-3:2025 §5.3.2 [PRE-1-RQ-02] target schedule for remediation.
I.3b — Access control / authenticationAnnex I Part I(2)(d)
Ensure protection from unauthorised access by appropriate control mechanisms — including but not limited to authentication, identity or access management systems — and report on possible unauthorised access.
How to satisfy it: Enforce authentication; no blank/shared defaults; document the mechanisms and how unauthorised-access attempts are reported.
What an assessor will ask for — Show who can reach the product and how they prove who they are, that the design says so, that it was tested, and that unauthorised attempts are reported.
- Authentication and access-control design Documentation · Annex VII(2)(a)
The interfaces that grant access, the mechanism on each (authentication, identity and access management), the roles and their permissions, and the credential policy, as designed.
Check: The design exists and covers every access path listed in the product context. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(d); prEN 40000-1-2:2025 §7.4.3–7.4.5 (the architecture and design shall be established and evidenced), with secure interface design and authentication described in §7.4.1 (General — informative). - Access-control test results Verification · Annex VII(6)
Tests showing authentication is enforced on each access path and that unauthorised attempts are refused.
Check: Results exist for every access path in the design. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.6.3–7.6.4.
I.3c — Confidentiality (encryption)Annex I Part I(2)(e)
Protect the confidentiality of stored, transmitted or otherwise processed data, personal or other, such as by encrypting relevant data at rest or in transit by state-of-the-art mechanisms.
How to satisfy it: Encrypt sensitive data at rest and in transit; record the algorithms.
What an assessor will ask for — Show which data the product protects and how, and that the protection is in place on the product as shipped.
- Data protection design Documentation · Annex VII(2)(a)
Which data the product stores, transmits or processes; how each class is protected at rest and in transit (algorithms, protocols, key lengths); and how keys and certificates are managed.
Check: Every data class in the asset list has a stated protection, and the cryptography is state of the art. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(e); prEN 40000-1-2:2025 §7.4.3 and §7.5.3 (management of cryptographic keys and certificates). - Confidentiality test results Verification · Annex VII(6)
Tests or inspections confirming data is encrypted where the design says it is — protocol negotiation checks, storage inspection, configuration review.
Check: Results correspond to the design's protection claims. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.6.3–7.6.4.
I.3d — Integrity & corruption reportingAnnex I Part I(2)(f)
Protect the integrity of stored, transmitted or otherwise processed data, commands, programs and configuration against any manipulation or modification not authorised by the user, and report on corruptions.
How to satisfy it: Signing/checksums/secure boot; tamper detection and reporting.
What an assessor will ask for — Show that data, commands, programs and configuration cannot be altered without authorisation, and that a corruption is detected and reported.
- Integrity protection design Documentation · Annex VII(2)(a)
How stored, transmitted and processed data, commands, programs and configuration are protected from unauthorised modification — signing, checksums, secure boot, verified updates — and how a corruption is detected and reported.
Check: The design covers data, commands, programs and configuration, and names the reporting path. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(f); prEN 40000-1-2:2025 §7.4.3; §7.7.2.3 (integrity and authenticity of distributed artefacts). - Integrity and tamper test results Verification · Annex VII(6)
Tests showing that modified firmware, configuration or data is detected and refused or reported — for example, a tampered image failing signature verification.
Check: Results exist for each protected class. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.6.3–7.6.4. - Corruption reporting demonstration Verification · Annex VII(6)
A demonstration that the product reports a detected corruption to the user or operator.
Check: The report is produced and visible. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(f); prEN 40000-1-2:2025 §7.8 (Annex C: report on corruptions).
I.3e — Data minimisationAnnex I Part I(2)(g)
Process only data, personal or other, that are adequate, relevant and limited to what is necessary in relation to the intended purpose.
How to satisfy it: Document what data is processed and why; remove the unnecessary.
What an assessor will ask for — Show that the product processes only the data its intended purpose needs.
- Data inventory with necessity justification Documentation · Annex VII(2)(a)
The data the product processes, personal or other, each tied to the function that needs it, with the justification that nothing beyond what the intended purpose requires is collected or retained — and for how long.
Check: Every data item maps to a purpose, and retention is bounded. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(g); prEN 40000-1-2:2025 §6.4.2.1 (data as assets) and §7.4 (Annex C mapping). - Data-flow verification Verification · Annex VII(6)
An inspection or test confirming the product transmits and stores only the inventoried data — a traffic capture, a storage inspection.
Check: Observed flows match the inventory. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.6.3.
I.3f — Availability & DoS resilienceAnnex I Part I(2)(h)
Protect the availability of essential and basic functions, also after an incident, including through resilience and mitigation measures against denial-of-service attacks.
How to satisfy it: Rate-limiting, watchdogs, failover; document DoS mitigations and post-incident recovery.
What an assessor will ask for — Show which functions are essential, how they keep working through an incident, and how the product resists denial of service.
- Essential functions and resilience design Documentation · Annex VII(2)(a)
Which functions are essential or basic, how they keep working during and after an incident, and the measures against denial-of-service — rate limiting, resource bounds, failover.
Check: Essential functions are named and each has a resilience measure. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(h); prEN 40000-1-2:2025 §7.4 (Annex C mapping). - Stress and denial-of-service test results Verification · Annex VII(6)
Stress or load tests showing the product's behaviour under resource exhaustion and after recovery.
Check: Essential functions survive or recover as designed. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.6.1 (stress testing) and §7.6.4.
I.3g — Minimise impact on other devices/networksAnnex I Part I(2)(i)
Minimise the negative impact by the product itself or connected devices on the availability of services provided by other devices or networks.
How to satisfy it: Prevent the product being abused to attack others; egress controls.
What an assessor will ask for — Show what the product does to the network around it, and that a misbehaving or compromised unit cannot degrade the services of other devices.
- Network behaviour description Documentation · Annex VII(2)(a)
What the product sends to the network and when, what it can do to connected devices, and the limits designed in so a compromised or misbehaving unit cannot degrade the services others provide.
Check: The description covers outbound traffic, connected-device interactions and the limiting measures. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(i); prEN 40000-1-2:2025 §7.4. - Network impact test Verification · Annex VII(6)
A traffic capture or test confirming the product's network behaviour matches the description, including under fault.
Check: Observed behaviour stays within the designed limits. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.6.3.
I.3h — Limit attack surfaceAnnex I Part I(2)(j)
Design, develop and produce the product to limit attack surfaces, including external interfaces.
How to satisfy it: Disable unused ports/services; document exposed interfaces.
What an assessor will ask for — Show every way in, that each one that is open is open for a reason, and that nothing else is exposed.
- Interface and attack-surface inventory Documentation · Annex VII(2)(a)
Every external interface — network ports and services, physical ports, APIs, debug and management interfaces — whether it is enabled by default, and the justification for each one that is.
Check: The inventory is complete against the architecture overview, and every enabled interface has a reason. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(j); prEN 40000-1-2:2025 §5.3.2 (attack surface minimisation), §6.2.1.5 (architecture overview: interfaces) and §7.4. - Exposed-surface scan Verification · Annex VII(6)
A port and service scan of the shipped product — and a check of physical and debug ports — compared with the inventory.
Check: Nothing is exposed that the inventory does not list as enabled. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.6.3 (verifying external interfaces and protocols).
I.3i — Exploitation mitigationAnnex I Part I(2)(k)
Design, develop and produce the product to reduce the impact of an incident using appropriate exploitation mitigation mechanisms and techniques.
How to satisfy it: Memory protections, sandboxing, least privilege; document techniques.
What an assessor will ask for — Show which techniques limit the damage an exploited vulnerability can do, and that they are actually switched on in the shipped build.
- Exploitation-mitigation techniques in use Documentation · Annex VII(2)(a)
The techniques the product uses to limit the impact of an exploited vulnerability — non-executable memory, address-space randomisation, stack protection, sandboxing, privilege separation, memory-safe languages — and where each one applies.
Check: The list is specific to the product's platform and components. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(k); prEN 40000-1-2:2025 §5.3.2 (defence in depth, secure coding, memory safety) and §7.4. - Mitigation verification on the release build Verification · Annex VII(6)
Build-configuration evidence or binary checks confirming the mitigations are enabled in the shipped build — compiler flags, hardening checks on the release artefact.
Check: Each claimed mitigation is verified on the release artefact. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.6.3 (reviewing implementation artefacts against secure implementation rules) and §7.6.4.
I.3j — Security logging / monitoring (user opt-out)Annex I Part I(2)(l)
Provide security-related information by recording and monitoring relevant internal activity, including the access to or modification of data, services or functions, with an opt-out mechanism for the user.
How to satisfy it: Security event logging with access records; document what is logged and how the user can opt out.
- Security-relevant internal activity is recorded and monitored — unconditional. The recording duty itself is unconditional for this point.
- The user can opt out of the monitoring — qualified: may be recorded not applicable, with a justification. Annex I Part I(2)(l) attaches the opt-out to the monitoring it describes; where no user-identifiable activity is recorded, say so here.
What an assessor will ask for — Show what security-relevant activity the product records, where it goes, and that the user can switch recording off.
- Logging and monitoring design Documentation · Annex VII(2)(a)
What security-relevant internal activity is recorded (access to and modification of data, services or functions), where the records go, how long they are kept, and how the user opts out.
Check: The design names the events, the storage and the opt-out. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(l); prEN 40000-1-2:2025 §7.4 and §7.9.1 NOTE 1 (recording relevant internal activity with an opt-out). - Logging test Verification · Annex VII(6)
A test that triggers the designed events and shows they are recorded, and that the opt-out stops recording.
Check: Recorded events match the design, and the opt-out works. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.6.3–7.6.4.
I.3m — Secure permanent data removal & transferAnnex I Part I(2)(m)
Provide the possibility for users to securely and easily remove on a permanent basis all data and settings and, where such data can be transferred to other products or systems, ensure that this is done in a secure manner.
How to satisfy it: A wipe/factory-reset that genuinely erases user data and settings; where you offer data transfer or migration, make it secure and document it.
- Users can permanently and securely remove all data and settings — unconditional. Unconditional for this point.
- Where data can be transferred to another product or system, that transfer is secure — qualified: may be recorded not applicable, with a justification. Qualified by \u201cwhere such data can be transferred\u201d. If your product offers no migration or export path, record that here rather than marking the whole point not applicable.
What an assessor will ask for — Show that a user can permanently remove their data and settings, transfer them securely where that is offered, and that the product is planned to be retired safely.
- Secure decommissioning plan Documentation · Annex VII(2)
The plan for retiring the product: which confidential assets (user data, settings, keys) must be removed and where they live, how the user removes or exports their data, how the product leaves its environment, and how it is disposed of securely — including obligations that extend beyond the end of support.
Check: The plan exists and covers each of those elements. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(m); prEN 40000-1-2:2025 §7.10.3–7.10.5. - Data removal and transfer test Verification · Annex VII(6)
A test showing the removal function leaves no recoverable user data or settings, and that a transfer to another product, where offered, is protected.
Check: A post-removal inspection finds nothing, and any transfer is protected. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part I(2)(m); prEN 40000-1-2:2025 §7.6.3. - User instructions for removal and export Documentation · Annex II
The instructions users receive on removing or exporting their data, removing security assets and configuration, and what is deleted automatically and when.
Check: The instructions exist in the information to the user. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.10.3 (user information and instructions on decommissioning); Annex II.
Annex I Part II — Vulnerability handling
II.1 — SBOM & vulnerability identificationAnnex I Part II(1)
Identify and document vulnerabilities and components, including a software bill of materials in a commonly used and machine-readable format covering at the very least the top-level dependencies.
How to satisfy it: Generate a CycloneDX/SPDX SBOM in CI; keep it current per version.
What an assessor will ask for — Show that every component is known and traceable, in a machine-readable bill of materials regenerated for each release, and that vulnerability information is matched against it.
- Product identification record Documentation · Annex VII(1)
The information that identifies this product and version unambiguously — manufacturer, product name, hardware and software identifiers — recorded separately for hardware and software where the product has both.
Check: The record exists with the identifiers. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.3.7 [PRE-6]; Annex VII(1)(b). - Software bill of materials for the release Record · Annex VII(8)
The SBOM for the released version in a machine-readable format (CycloneDX or SPDX), with author, version and timestamp, covering at least the top-level dependencies — each with producer, name, version, unique identifiers and dependency relationships. Regenerated for every new build or release.
Check: The SBOM exists for this release, is machine-readable, and carries the required metadata and component fields. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part II(1); prEN 40000-1-3:2025 §5.3.8 [PRE-7-RQ-03 to RQ-07]; prEN 40000-1-2:2025 §7.5.3. - Hardware component list Documentation · Annex VII(2)(a)
For a product with hardware: the list of integrated hardware components with producer, name, identifier and firmware version. Mark this as not applying for software-only products.
Check: The list exists and is complete against the architecture. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.3.9 [PRE-8]. - Monitored vulnerability sources Process · Annex VII(2)(b)
The list of sources you monitor for vulnerability information — at least the EU Vulnerability Database and the reports you receive, plus your own regular testing and reviews — and the record of relevant information found.
Check: The source list exists, and a record of relevant vulnerability information is kept. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.4.3 [RCP-2]. - Matching of vulnerabilities to components Record · Annex VII(6)
Evidence that incoming vulnerability information is compared with the SBOM and the hardware list to identify potentially affected components. The built-in scan and its rescans produce this record for software.
Check: Identification activity is evidenced, and potentially affected components are listed with the vulnerability information. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.4.4 [RCP-3] and §5.4.5 [RCP-4].
II.2 — Remediate without delay; ship security fixes separatelyAnnex I Part II(2)
In relation to the risks posed to the product, address and remediate vulnerabilities without delay, including by providing security updates. Where technically feasible, new security updates must be provided separately from functionality updates.
How to satisfy it: Documented triage-to-fix-to-release process with timelines; decouple security patches from feature releases where technically feasible.
What an assessor will ask for — Show there is a working process from a vulnerability arriving to a fix shipping: policy, triage, decision, fix, test, release, follow-up.
- Vulnerability handling policy Process · Annex VII(2)(b)
Your internal policy on handling vulnerabilities: responsibilities, measures against premature disclosure, the target schedule for remediation, and the test-and-review strategy — and evidence that its effectiveness is monitored.
Check: The policy exists, covers the handling activities, and is monitored. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part II(2); prEN 40000-1-3:2025 §5.3.2 [PRE-1-RQ-01 to RQ-05] and its assessment criteria. - Verification and prioritisation records Record · Annex VII(6)
For vulnerabilities received or found: the assessment of validity and severity, the risk assessment and the priority assigned, and the communication with the reporter — including which cases were expedited.
Check: Records show investigation, tracking, severity and priority for each case. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.5.2 [VRF-1] and §5.5.3 [VRF-2]. - Remediation decisions, plans and test reports Record · Annex VII(6)
For each remediated vulnerability: the decision on how to fix it, the plan with its timeline, the fix produced, and the test showing the risk is mitigated without unacceptable impact on the product or its users.
Check: Decision, plan, produced remediation and test report exist per case. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.6.2 [RMD-1], §5.6.3 [RMD-2] and §5.6.4 [RMD-3]. - Separation of security updates from function updates Documentation · Annex VII(2)(b)
How security updates are delivered separately from functionality updates — or the technical reason they cannot be.
Check: Either the separation is shown or the infeasibility is justified. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part II(2); prEN 40000-1-3:2025 §5.6.3 [RMD-2-RQ-02]. - Operational security for vulnerability information Process · Annex VII(2)(b)
The measures that limit access to non-public vulnerability information on a need-to-know basis during handling and disclosure.
Check: Documented security measures exist. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.3.4 [PRE-3]. - Post-release actions Record · Annex VII(6)
Case maintenance and monitoring of released remediations, and the lessons captured for future development.
Check: Post-release actions are documented and carried out. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.8.2 [PRA-1].
II.3 — Regular security testingAnnex I Part II(3)
Apply effective and regular tests and reviews of the security of the product.
How to satisfy it: Pen tests / SAST / DAST on a schedule; keep the reports as evidence.
What an assessor will ask for — Show that testing and review are planned on the basis of risk, happen on that schedule, and feed back into the plan.
- Security test and review plan Process · Annex VII(2)(b)
The risk-based plan with the schedule and frequency of tests and reviews, considering the product context, architecture, security requirements, risk assessment and test methodologies — and its updates from what the tests and reviews found.
Check: The plan exists and is maintained from performed tests and reviews. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part II(3); prEN 40000-1-3:2025 §5.3.10 [PRE-9-RQ-01 to RQ-04]; prEN 40000-1-2:2025 §7.2.3 (recurring testing and review schedule). - Security test results, as planned Record · Annex VII(6)
The results of the tests the plan schedules — penetration tests, fuzzing, static analysis, vulnerability scans — with dates, showing they were performed as planned.
Check: Tests were performed as planned and their results exist. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.4.7 [RCP-6]; prEN 40000-1-2:2025 §7.6.4. - Security review results Record · Annex VII(6)
The results of the reviews the plan schedules — of the threat landscape, the state of the art, vulnerabilities in similar products, conditions of practical use — including the at-least-yearly re-review of the risk assessment's assumptions and inputs, and any plan updates they caused.
Check: Reviews were performed against the defined sources, and the risk assessment was reviewed at least annually. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.4.8 [RCP-7-RQ-01 and RQ-02]; prEN 40000-1-2:2025 §6.7.
II.4 — Disclose fixed vulnerabilitiesAnnex I Part II(4)
Once a security update is available, share and publicly disclose information about fixed vulnerabilities (description, affected products, impact, severity, remediation help). In duly justified cases, where you consider the security risks of publication to outweigh the benefits, you may delay publication until users have been given the possibility to apply the patch.
How to satisfy it: Publish security advisories (e.g. CSAF) when you ship fixes; document any justified publication delay.
What an assessor will ask for — Show that once a fix is out, users are told what was fixed, in enough detail to act, and that any delay was justified.
- Published information on fixed vulnerabilities Record · Annex VII(2)(b)
The advisories published once a security update was available: description, identifier, identification of the affected product, impact, severity, remediation steps, release and update dates — human-readable, and machine-readable where the product's risk profile calls for it. Advisories published from this workspace count.
Check: Published information exists per fixed vulnerability with the required elements. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part II(4); prEN 40000-1-3:2025 §5.7.3 [RLS-2-RQ-01 to RQ-03] and [RLS-2-RQ-03-RE] machine-readable advisories (CSAF). - Rationale for any delayed publication Documentation · Annex VII(2)(b)
Where publication was delayed because the security risks of publishing outweighed the benefits: the evaluation, the interim information users were given, and the disclosure date they were told. Mark this as not applying if nothing was delayed.
Check: A rationale exists for each delay. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part II(4) (duly justified cases); prEN 40000-1-3:2025 §5.7.3 [RLS-2-PM-01]. - Publication to the EU Vulnerability Database Record · Annex VII(2)(b)
Evidence that fixed vulnerabilities were made available on the EU Vulnerability Database, directly or through the CVE programme.
Check: Evidence exists, where applicable. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.7.3 [RLS-2-RC-01].
II.5 — Coordinated vulnerability disclosure policyAnnex I Part II(5)
Put in place and enforce a coordinated vulnerability disclosure (CVD) policy.
How to satisfy it: Publish a CVD/security policy and a security.txt with the single point of contact.
What an assessor will ask for — Show that a disclosure policy is published, reachable, and actually followed.
- Published coordinated vulnerability disclosure policy Process · Annex VII(2)(b)
The disclosure policy, published in an accessible format: the contact mechanisms (reachable through more than one sensory channel), the expectations for ongoing communication with reporters, and the disclosure and embargo approach.
Check: The policy is published, followed, aligned with the internal handling policy, and its contact mechanisms are accessible. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part II(5); prEN 40000-1-3:2025 §5.3.3 [PRE-2-RQ-01 to RQ-03] and its assessment criteria. - Reachable disclosure channel Verification · Annex VII(2)(b)
Evidence that the published channel works: the security.txt file (RFC 9116) or the policy page as actually served, and where it is published.
Check: The channel is publicly reachable. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.4.2 [RCP-1] (security.txt as an additional consideration).
II.6 — Facilitate info-sharing & reporting contactAnnex I Part II(6)
Take measures to facilitate the sharing of information about potential vulnerabilities in the product and in third-party components it contains, including a contact address for reporting vulnerabilities discovered in the product.
How to satisfy it: Monitored security contact; process for inbound reports and third-party components.
What an assessor will ask for — Show that anyone who finds a vulnerability can report it, that the report is tracked and acknowledged, and that upstream suppliers are told about problems in their components.
- Reporting mechanism and contact address Process · Annex VII(2)(b)
The publicly available, accessible means of reporting a vulnerability — the contact address, web form or tracker — and how reports are tracked with an identifier and acknowledged within the time the disclosure policy declares.
Check: A public, accessible mechanism exists, and received reports are stored with tracking identifiers. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part II(6); prEN 40000-1-3:2025 §5.4.2 [RCP-1-RQ-01 to RQ-03]. - Secure communication option Documentation · Annex VII(2)(b)
The secure means offered for sensitive reports — a TLS web form, encrypted email — and evidence it was used where reports came in.
Check: The mechanism is documented and, where reports exist, was used. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.3.6 [PRE-5]. - Upstream stakeholder map Documentation · Annex VII(2)(b)
The list of upstream suppliers and open-source projects behind the product's components, checked for completeness against the SBOM, and how vulnerabilities found in their components are communicated to them.
Check: The list exists and is complete against the SBOM. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.3.2 [PRE-1-RQ-04] and its assessment criteria; prEN 40000-1-2:2025 §7.11.3 (discovered vulnerabilities disclosed to the third party). - Fixes shared back to the component's maintainer Record · Annex VII(2)(b)
Where you fixed a vulnerability in a third-party or open-source component yourself, evidence that you shared the fix — the code, or the documentation of it — with the person or entity that maintains that component. Mark this as not applying if you have never developed such a fix.
Check: For each fix developed on a component you do not maintain, the share is evidenced: a pull request, a patch sent, an issue with the fix attached. Basis: Regulation (EU) 2024/2847. Sources: Art. 13(6), second sentence — the manufacturer shares the fix, or the documentation of it, with the person or entity maintaining the component.
II.7 — Secure update distributionAnnex I Part II(7)
Provide for mechanisms to securely distribute updates to ensure that vulnerabilities are fixed or mitigated in a timely manner and, where applicable for security updates, in an automatic manner.
How to satisfy it: Signed updates over secure channels; on-device integrity verification; automatic distribution where applicable.
What an assessor will ask for — Show that updates cannot be tampered with on the way to the product, that they arrive in time, and automatically where the product supports it.
- Secure distribution mechanism Documentation · Annex VII(2)(b)
How updates are protected in distribution — signing for authenticity, integrity protection in transit and in storage, authenticated access to the hosting location — and the automatic distribution mechanism where the product supports one.
Check: The mechanism ensures authenticity and integrity, and automatic distribution exists where applicable. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part II(7); prEN 40000-1-3:2025 §5.3.11 [PRE-10] and §5.7.2 [RLS-1-RQ-04]; prEN 40000-1-2:2025 §7.7.2.3–7.7.2.5 (secure digital production and distribution). - Distribution evidence Verification · Annex VII(6)
Evidence of a security update actually distributed through the mechanism, and of the installation instructions provided where distribution is not fully automated.
Check: Distribution and instructions are evidenced. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.7.2.5 [RLS-1] assessment criteria. - Expedited handling for critical vulnerabilities Process · Annex VII(2)(b)
The rule that a vulnerability whose risk exceeds your threshold is resolved outside the normal update cycle, and a case where it applied if one exists.
Check: The rule exists in the policy, and expedited cases are evidenced. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.5.3 [VRF-2-RQ-03]; Annex I Part II(7) (in a timely manner).
II.8 — Free & timely patches with advisoriesAnnex I Part II(8)
Where security updates are available, disseminate them without delay and — unless otherwise agreed between manufacturer and business user for a tailor-made product — free of charge, accompanied by advisory messages giving users the relevant information, including on potential action to be taken.
How to satisfy it: Patches free and prompt; advisory tells users what action to take; record any tailor-made agreement.
What an assessor will ask for — Show that security updates are free, go out without delay, and come with an advisory that tells users what to do.
- Security updates free of charge Documentation · Annex VII(2)(b)
The statement, in your terms or user information, that security updates are provided free of charge — or the agreement with a business user for a tailor-made product that says otherwise.
Check: The commitment, or the agreement, exists. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part II(8); prEN 40000-1-3:2025 §5.7.2 [RLS-1-RQ-01]. - Timely dissemination record Record · Annex VII(6)
For released security updates, the dates from availability to distribution, showing dissemination without delay, and the advisory that accompanied each with the action users should take.
Check: Dates and advisories exist per update. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Annex I Part II(8); prEN 40000-1-3:2025 §5.7.2 [RLS-1-RQ-02] and §5.7.3 [RLS-2]. - Installation instructions Documentation · Annex II
The installation instructions provided with security updates where installation is not fully automatic.
Check: Instructions exist for manual updates. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.7.2 [RLS-1-RQ-03].
Process & lifecycle obligations (Articles 13 & 14)
P.1 — Third-party & open-source component due diligenceArticle 13(5)-(6)
Exercise due diligence on integrated third-party components (incl. FOSS); on finding a component vulnerability, report it upstream to the maintainer and share fixes.
How to satisfy it: Track component provenance; monitor upstream advisories; have an upstream-reporting process.
What an assessor will ask for — Show that components from others were chosen with care, carried into the risk work, and are watched.
- Component selection justification Documentation · Annex VII(2)
For each third-party component, why it was selected and what was checked: CE marking where available, known vulnerabilities in the EU Vulnerability Database or other public databases, secure-by-design indicators, patch availability, vulnerability handling, its own risk assessment, and its support period.
Check: Documented due diligence exists for the selection and integration of third-party components. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Art. 13(5); prEN 40000-1-2:2025 §7.11.3–7.11.5 (due diligence applied to the selection; the selection justified and documented), with the list of things to check described in §7.11.1 (General — informative). - Third-party components in the risk assessment Documentation · Annex VII(3)
Evidence that third-party components and their integration were included in the risk assessment and treatment, securely integrated, verified, added to the SBOM and monitored over their lifecycle.
Check: The risk assessment covers the components, and the other activities reference them. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.11.3; Guidance C(2026) 5252 §7.3. - Supplier agreements (where responsibilities are shared) Documentation · Annex VII(2)
Agreements with component or service suppliers that allocate security responsibilities between you and them — the cybersecurity supplier agreement pattern or an equivalent. Mark this as not applying where no responsibilities are shared.
Check: Agreements exist where responsibilities are distributed. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 Annex B (informative).
P.2 — Vulnerability handling for the whole support periodArticle 13(8)
Handle vulnerabilities effectively for the entire support period (at least 5 years, or expected use time if shorter).
How to satisfy it: Resourced process that runs for the full support period, not just at launch.
What an assessor will ask for — Show that vulnerability handling is planned for the whole support period and that the product is actually being watched.
- Support-period commitment and plan Documentation · Annex VII(4)
The support period as determined and its rationale, with the plan for vulnerability handling, updates and component obsolescence across that whole period.
Check: The period is determined per Art. 13(8), and the plan covers all of it. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Art. 13(8); prEN 40000-1-2:2025 §7.2.3 (support period; update, upgrade and obsolescence planning); Guidance C(2026) 5252 §5. - Product monitoring record Record · Annex VII(2)(c)
Evidence that the product is monitored for security issues across its lifecycle, including the end of support of the third-party components it contains.
Check: The monitoring output exists and is current. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-2:2025 §7.9.3–7.9.5; prEN 40000-1-3:2025 §5.4.3 [RCP-2-RQ-04]. - Effectiveness monitoring of vulnerability handling Record · Annex VII(2)(b)
How the effectiveness of the vulnerability handling process is measured over time — time to remediate, cases per period — and the results.
Check: Evidence of process monitoring exists. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: prEN 40000-1-3:2025 §5.3.2 [PRE-1-RQ-03].
P.3 — Security-update availability retentionArticle 13(9)
Keep each issued security update available for at least 10 years or the remainder of the support period, whichever is longer.
How to satisfy it: Archive/host updates for the required retention.
What an assessor will ask for — Show that a security update, once issued, stays available for as long as the regulation requires.
- Update retention policy Process · Annex VII(2)(b)
Your policy that each security update stays available for ten years after it is issued or for the rest of the support period, whichever is longer, and where retained updates are kept.
Check: The policy exists and names the retention location. Basis: Regulation (EU) 2024/2847. Sources: Art. 13(9). - Availability of past updates Record · Annex VII(6)
Evidence that previously issued security updates remain retrievable — a listing of the update archive with issue dates.
Check: Past updates are still available. Basis: Regulation (EU) 2024/2847. Sources: Art. 13(9).
P.4 — Reporting of actively exploited vulnerabilities & severe incidentsArticle 14
Report to the CSIRT coordinator and ENISA via the Single Reporting Platform. Actively exploited vulnerabilities: 24h early warning, 72h notification, final report no later than 14 days after a corrective or mitigating measure is available. Severe incidents: 24h early warning, 72h notification, final report within 1 month of the incident notification. Inform impacted users. Binds every manufacturer from 11 September 2026, including for products placed on the market before 11 December 2027 (Art. 69(3)) — it cannot be disapplied by a risk-assessment justification.
How to satisfy it: Have the process, owner and templates ready before September 2026. ENISA schedules the Single Reporting Platform to be operational by 11 September 2026 — verify current status.
What an assessor will ask for — Show that if a vulnerability is being exploited or a severe incident hits, the right person will file on the Single Reporting Platform inside the clocks, and users will be told.
- Article 14 reporting procedure Process · Annex VII(2)(b)
The procedure for reporting an actively exploited vulnerability or a severe incident: who decides, who files on the Single Reporting Platform (with working EU Login access), and the 24-hour, 72-hour and final-report steps. The Article 14 panel in this assessment records the owner and the drills.
Check: A procedure with named roles and the three stages exists. Basis: Regulation (EU) 2024/2847. Sources: Art. 14(1)–(5); Art. 16 (single reporting platform); Guidance C(2026) 5252 §9.1. - Reporting rehearsal or filing record Record · Annex VII(6)
A dated rehearsal of the reporting procedure, or the record of a real filing. The drill recorded in this assessment counts.
Check: At least one dated drill or filing exists. Basis: Commission guidance C(2026) 5252. Sources: Art. 14; Guidance C(2026) 5252 §9.1. - Informing users of an exploited vulnerability or incident Process · Annex VII(2)(b)
How affected users are informed without undue delay, including any corrective measures they can take themselves.
Check: The procedure includes user notification. Basis: Regulation (EU) 2024/2847. Sources: Art. 14(8).
P.5 — Support-period end date disclosed, expiry notifiedArticle 13(19)
State the end date of the support period at the time of purchase, clearly and understandably, giving at least the month and year. Once the support period expires, show users a notification where that is technically feasible given the nature of the product.
How to satisfy it: Show the support end date in the purchase flow, on the product page or on packaging, and carry the same date into the Annex II user information. Add an in-product or update-channel notice at expiry, or record why that is not technically feasible for this product.
What an assessor will ask for — Show that buyers can see the end of support before they buy, and that users are told when it arrives.
- End-of-support date at the point of purchase Documentation · Annex II
Where the support end date is stated so that it is clear and accessible at the time of purchase — packaging, product page, user information.
Check: The date is stated at purchase and matches the determination. Basis: Regulation (EU) 2024/2847. Sources: Art. 13(19); Guidance C(2026) 5252 §5. - End-of-support notification Process · Annex VII(2)
How users are notified when the support period ends and what the end means for continued use of the product, as planned in the decommissioning plan.
Check: The notification method and its content are planned. Basis: prEN 40000 draft (CEN enquiry; not yet cited in the OJ). Sources: Art. 13(19); prEN 40000-1-2:2025 §7.10.1 and §7.10.3 (obligations that extend beyond the end of support).
P.6 — CE marking affixed correctlyArticles 29–30
Affix the CE marking visibly, legibly and indelibly to the product with digital elements. Where that is not possible or not warranted by the product's nature, put it on the packaging and the accompanying documentation. For a product made available in a form other than physical — software — the marking goes on the EU declaration of conformity or on the website accompanying the product. Where a notified body is involved in the production control phase, its identification number follows the CE marking.
How to satisfy it: Point at where the marking is actually affixed: the device or its data plate, the packaging and documentation, or — for software — the declaration of conformity and the download or product page. Check the marking's proportions and legibility against the general principles of Article 30 of Regulation (EC) No 765/2008, and record the notified body number placement if one is involved. The marking may only be affixed once the declaration of conformity can honestly be signed — it is the last step, not a design element.
What an assessor will ask for — Show the marking as it is actually affixed, and the declaration it stands on.
- CE marking as affixed Verification · Annex VII(1)(c)
A photograph or screenshot of the CE marking as affixed to the product, its packaging or — for software — its documentation or accompanying information.
Check: The marking is visible, legible and, where physical, indelible. Basis: Regulation (EU) 2024/2847. Sources: Art. 30(1)–(3); Regulation (EC) No 765/2008 Art. 30. - Declaration behind the marking Documentation · Annex VII(7)
The EU declaration of conformity the marking relies on — generated from this assessment once every requirement is met and signed.
Check: A signed declaration exists for this version. Basis: Regulation (EU) 2024/2847. Sources: Art. 28; Annex V.
Conformity routes
Which conformity assessment procedure a product may use depends on its category. These are the four verdicts the product renders, verbatim — including their as-of hedges, because what is not yet in place (harmonised standards cited in the Official Journal, designated notified bodies, an Article 8(1) delegated act) is part of the answer.
Default
Route: self-assessment · Module: A
You can self-assess: the internal control procedure (Module A, Annex VIII Part I) is always available for default-category products (Art. 32(1)).
Any product with digital elements not listed in Annex III or IV.
Important — Annex III, Class I
Route: conditional · Module: A only with standards; else B+C, H, or certification scheme
Self-assessment (Module A) is available only where you apply, in full, relevant harmonised standards, common specifications or a European cybersecurity certification scheme at assurance level at least 'substantial', covering at least the risks of the product's core functionality (Art. 32(2); guidance §6.2). No CRA harmonised standard is cited in the Official Journal yet (as of August 2026 — verify current status), so today the route is Module B+C, Module H or, where available and applicable, such a certification scheme. Products qualifying as free and open-source software may instead use Module A with publicly available technical documentation (Art. 32(5)).
Important — Annex III, Class II
Route: third-party · Module: B+C, H, or certification scheme (≥ substantial)
Third-party conformity assessment is mandatory (Art. 32(3)): EU-type examination plus conformity to type (Module B+C), full quality assurance (Module H), or — where available and applicable — a European cybersecurity certification scheme pursuant to Art. 27(9) at assurance level at least 'substantial'. Products qualifying as free and open-source software may instead use Module A with publicly available technical documentation (Art. 32(5)). Note: no notified bodies are designated under the CRA yet (as of August 2026 — verify current status and plan lead time).
Critical — Annex IV
Route: certification-or-third-party · Module: Certification per Art. 8(1) delegated act; until then B+C, H, or scheme (≥ substantial)
A delegated act under Art. 8(1) may in future require a European cybersecurity certificate (e.g. under the EUCC scheme) at a set assurance level. No such delegated act has been adopted (as of August 2026 — verify current status), so Annex IV products are currently subject to the Article 32(3) procedures: Module B+C, Module H or, where available and applicable, a European cybersecurity certification scheme at assurance level at least 'substantial' (Art. 8(1); Art. 32(4)).
The classification layer
Decision tree 0.2.0, authored against pack 0.4.0 · Annex III / IV as described by IR (EU) 2025/2392
Before any requirement is evaluated, the product classifies what is being assessed. These are the exact category items the classifier walks, highest tier first, each with the official Annex III/IV wording and the scope notes from the implementing regulation’s binding technical descriptions — the second thing a reviewer should read, because classification decides which conformity route above applies.
Classification turns on the CORE FUNCTIONALITY of your product as a whole — the main features without which it could not meet its intended purpose (guidance C(2026) 5252 §6.1). Integrating a component that is itself an important or critical product does not in itself make your product important or critical (Art. 7(1) for important products; extended to critical products by analogy in guidance §6.1 para 141); ancillary extra functions neither put a product into a category nor take it out; and a product has at most one core functionality for determining the conformity assessment regime. Identify that core functionality consistently in your technical documentation, instructions and marketing — misrepresenting it to escape a regime is prohibited (guidance §6.1). Modules also sold separately are classified on their own core functionality. Near a contested boundary (e.g. radio modules, embedded gateways, multi-function suites), record your reasoning and consider legal review: this result is indicative, not legal advice.
Critical products (Annex IV)Annex IV; IR (EU) 2025/2392 Annex II
Is the core functionality of your product — as a whole, not a component it merely integrates — one of the following?
A hardware device with a security box: multiple discrete components in a physical envelope providing tamper evidence, resistance or response
Official wording: “Hardware Devices with Security Boxes”IR (EU) 2025/2392 Annex II, point 1
e.g. a physical payment terminal, a hardware security module (HSM) appliance, a tachograph meeting the description
Scope note: Requires multiple discrete components plus a hardware physical envelope against physical attack — a single hardened chip is not a security box (see the smartcard/secure-element item and the Class I/II chip items instead).
A smart-meter gateway within a smart metering system, or another device for advanced security purposes including secure cryptoprocessing
Official wording: “Smart meter gateways within smart metering systems as defined in Article 2, point (23) of Directive (EU) 2019/944 and other devices for advanced security purposes, including for secure cryptoprocessing”IR (EU) 2025/2392 Annex II, point 2
e.g. the gateway between household electricity meters and the utility, a dedicated secure cryptoprocessing unit
Scope note: The gateway limb is anchored to smart metering systems under Directive (EU) 2019/944 (primarily electricity; gas/heat only where the description fits). The 'other devices for advanced security purposes' limb has no separate IR description — assess it against the category wording itself and document your reasoning.
A smartcard or similar device, including a secure element
Official wording: “Smartcards or similar devices, including secure elements”IR (EU) 2025/2392 Annex II, point 3
e.g. a chip bank card, an eID or travel-document chip, a TPM, an embedded UICC — secure elements are, by the IR's definition, designed to provide at least AVA_VAN.4
Scope note: Secure elements are tamper-protected micros designed to provide at least AVA_VAN.4 (Common Criteria). HSMs are NOT in this item — the IR places hardware security modules under Hardware Devices with Security Boxes. Tamper-resistant chips designed to AVA_VAN 2-3 belong in Class II.
Important products — Class II (Annex III)Annex III, Class II; IR (EU) 2025/2392 Annex I
If not: is the core functionality of your product one of these Class II categories?
A hypervisor, or a container runtime system supporting virtualised execution
Official wording: “Hypervisors and container runtime systems that support virtualised execution of operating systems and similar environments”IR (EU) 2025/2392 Annex I, Class II, point 1
e.g. a bare-metal (type-1), hosted (type-2) or nested hypervisor; a container runtime managing containers on a single host operating system
Scope note: The IR describes container runtimes as managing container execution and lifecycle on a single host operating system. Whether a multi-host orchestration layer falls in the category is not expressly addressed — the single-host limb suggests not, but document your reasoning.
A firewall (network or application), or an intrusion detection / prevention system
Official wording: “Firewalls, intrusion detection and prevention systems”IR (EU) 2025/2392 Annex I, Class II, point 2
e.g. a network firewall appliance, a web application firewall (WAF), a content filter or anti-spam gateway, a network- or host-based IDS/IPS
Scope note: The IR expressly includes application firewalls such as web application firewalls, filters and anti-spam gateways, and both network-based and host-based IDS/IPS.
A tamper-resistant microprocessor (designed to AVA_VAN level 2 or 3)
Official wording: “Tamper-resistant microprocessors”IR (EU) 2025/2392 Annex I, Class II, point 3
e.g. a CPU with tamper evidence/resistance/response designed to Common Criteria AVA_VAN 2-3
Scope note: Class II requires tamper features AND a design assurance of AVA_VAN level 2 or 3. Chips designed to AVA_VAN.4 or higher (typical for payment/eID parts) are critical secure elements; security chips without that tamper/assurance design are Class I.
A tamper-resistant microcontroller (designed to AVA_VAN level 2 or 3)
Official wording: “Tamper-resistant microcontrollers”IR (EU) 2025/2392 Annex I, Class II, point 4
e.g. an MCU with anti-tamper protections designed to Common Criteria AVA_VAN 2-3
Scope note: Same ladder as microprocessors: AVA_VAN 2-3 here; AVA_VAN.4+ parts are critical secure elements; below that, Class I.
Important products — Class I (Annex III)Annex III, Class I; IR (EU) 2025/2392 Annex I
If not: is the core functionality of your product one of these Class I categories?
Identity management or privileged-access management software or hardware, including authentication and access-control readers
Official wording: “Identity management systems and privileged access management software and hardware, including authentication and access control readers, including biometric readers”IR (EU) 2025/2392 Annex I, Class I, point 1
e.g. an SSO or federated-identity platform, multi-factor or one-time-password authentication software, a TAN generator, PAM software, a badge or fingerprint access reader
Scope note: Covers systems providing authentication or authorisation (optionally full credential lifecycle) for persons, devices or systems — including access to physical locations; PAM controls and monitors privileged access to IT/OT systems.
A web browser (standalone or embedded)
Official wording: “Standalone and embedded browsers”IR (EU) 2025/2392 Annex I, Class I, point 2
e.g. a desktop browser, an embedded browser supplied for integration into smart TVs or other devices (the browser product itself — not the device that merely contains one), a browser with AI agent integration
A password manager
Official wording: “Password managers”IR (EU) 2025/2392 Annex I, Class I, point 3
e.g. a local app, browser extension, enterprise or hardware-based password manager that stores, generates or shares passwords
Scope note: Dedicated password management is the category; a product that merely stores credentials incidentally is not classified here unless that is its core functionality.
Software that searches for, removes or quarantines malicious software
Official wording: “Software that searches for, removes, or quarantines malicious software”IR (EU) 2025/2392 Annex I, Class I, point 4
e.g. endpoint antivirus, real-time or manual malware scanners, rootkit detection, a rescue disk with that core function
A product with the function of a virtual private network (VPN)
Official wording: “Products with digital elements with the function of virtual private network (VPN)”IR (EU) 2025/2392 Annex I, Class I, point 5
e.g. a VPN client, server or gateway
Scope note: The IR describes VPNs as establishing an ENCRYPTED logical tunnel — products offering only unencrypted tunnelling are not in this category.
A network management system
Official wording: “Network management systems”IR (EU) 2025/2392 Annex I, Class I, point 6
e.g. an end-to-end network management system or SDN controller that monitors AND controls network elements' operations and configuration
Scope note: Both limbs are required: monitoring and controlling connected network elements (servers, routers, switches, workstations, printers, mobile devices). Monitoring-only tools fall short of the description.
A security information & event management (SIEM) system
Official wording: “Security information and event management (SIEM) systems”IR (EU) 2025/2392 Annex I, Class I, point 7
e.g. a platform that collects security data from multiple sources, correlates it, and presents actionable information
Scope note: The description is multi-source collection PLUS analysis/correlation for security purposes. SOAR software is generally not a SIEM (IR recital 5); log collection or visualisation without correlation falls short.
A boot manager
Official wording: “Boot managers”IR (EU) 2025/2392 Annex I, Class I, point 8
e.g. UEFI firmware, a single-stage or multi-stage boot loader
Scope note: Expressly includes UEFI firmware — firmware vendors are in scope, not only OS boot loaders.
Public-key infrastructure or digital-certificate issuance software
Official wording: “Public key infrastructure and digital certificate issuance software”IR (EU) 2025/2392 Annex I, Class I, point 9
e.g. certificate authority software, key management systems, OCSP responders, an all-in-one PKI solution
Scope note: Covers certificate lifecycle (validation, creation, issuance, distribution, status publication, renewal, revocation) and management of cryptographic keys associated with such certificates.
A physical or virtual network interface
Official wording: “Physical and virtual network interfaces”IR (EU) 2025/2392 Annex I, Class I, point 10
e.g. wired/wireless NICs, controllers and adapters (Wi-Fi, Ethernet, USB, Bluetooth, Zigbee, IrDA, NearLink, Fieldbus), virtual NICs, container network interfaces, VPN interfaces
Scope note: Broader than network cards: the IR covers adapters for short-range and industrial protocols and purely virtual standalone interfaces. Radio modules and embedded adapters placed on the market separately can fall here — a contested edge worth documenting.
An operating system
Official wording: “Operating systems”IR (EU) 2025/2392 Annex I, Class I, point 11
e.g. a desktop, server, mobile or embedded OS — expressly including real-time operating systems (RTOS) and special-purpose OSs
Scope note: Software providing an abstract interface to hardware and controlling software execution. A device that merely RUNS an OS is not classified here — this item is for the OS placed on the market as a product.
A router, a hardware modem for internet connection, or a managed switch
Official wording: “Routers, modems intended for the connection to the internet, and switches”IR (EU) 2025/2392 Annex I, Class I, point 12
e.g. a home or virtual router, a DSL/DOCSIS/fibre/satellite/cellular modem, a managed/smart/SDN switch, a wireless access point
Scope note: Switches must have a MANAGEMENT PLANE — unmanaged switches are not in the category. Modems here are hardware products using digital modulation/demodulation for IP communication; routers may be hardware or virtual.
A microprocessor with security-related functionalities
Official wording: “Microprocessors with security-related functionalities”IR (EU) 2025/2392 Annex I, Class I, point 13
e.g. a CPU with a secure enclave, secure-boot support or hardware key storage protecting more than the chip itself
Scope note: The security functionalities must aim to secure other products, networks or services BEYOND the chip itself (secure boot chain, TEE, secure communications). If the chip is also tamper-resistant to AVA_VAN 2-3, check Class II; AVA_VAN.4+, check critical.
A microcontroller with security-related functionalities
Official wording: “Microcontrollers with security-related functionalities”IR (EU) 2025/2392 Annex I, Class I, point 14
e.g. an MCU with secure-boot or hardware crypto features protecting more than the chip itself
Scope note: Same 'beyond the chip itself' test as microprocessors, and the same tamper-resistance ladder into Class II / critical.
An ASIC or FPGA with security-related functionalities
Official wording: “Application specific integrated circuits (ASIC) and field-programmable gate arrays (FPGA) with security-related functionalities”IR (EU) 2025/2392 Annex I, Class I, point 15
e.g. a custom or reprogrammable chip performing encryption or key storage for other products or networks
Scope note: Same 'beyond the chip itself' test: purely self-protective features do not put a chip in this category.
A smart-home general-purpose virtual assistant
Official wording: “Smart home general purpose virtual assistants”IR (EU) 2025/2392 Annex I, Class I, point 16
e.g. a smart speaker with an integrated voice assistant, a standalone virtual assistant
Scope note: Requires natural-language processing (spoken or written) and communication on the public internet, serving residential settings. A smart-home hub without natural-language interaction is not in this category.
A smart-home product with security functionalities, or the hardware/software that centrally controls such products
Official wording: “Smart home products with security functionalities, including smart door locks, security cameras, baby monitoring systems and alarm systems”IR (EU) 2025/2392 Annex I, Class I, point 17
e.g. a smart door lock, home security camera, baby monitor or alarm system, and the hub or app that centrally controls them
Scope note: Protects the physical security of consumers in residential settings and is remotely controllable or manageable; central controllers of such products are expressly included.
An internet-connected toy (under the Toy Safety Directive) with social-interactive or location-tracking features
Official wording: “Internet connected toys covered by Directive 2009/48/EC that have social interactive features (e.g. speaking or filming) or that have location tracking features”IR (EU) 2025/2392 Annex I, Class I, point 18
e.g. a toy that converses with children via microphone/speaker/camera, or a toy that tracks its or the user's location
Scope note: Must be a toy under Directive 2009/48/EC communicating on the public internet. Social-interactive means two-way (inbound and outbound) communication; merely detecting the proximity of the user or other toys is NOT location tracking.
A personal health-monitoring wearable (outside MDR/IVDR), or a wearable intended for use by and for children
Official wording: “Personal wearable products to be worn or placed on a human body that have a health monitoring (such as tracking) purpose and to which Regulation (EU) 2017/745 or (EU) No 2017/746 do not apply, or personal wearable products that are intended for the use by and for children”IR (EU) 2025/2392 Annex I, Class I, point 19
e.g. a fitness tracker, smartwatch or smart clothing sensing body metrics regularly or continuously; a child-safety wearable (children = under 14, no health-monitoring needed on that limb)
Scope note: Health-monitoring limb: regular or continuous sensing and processing of health-relevant body metrics, excluding products under the medical-device regulations. Children's limb: wearables for individuals under 14 — no health-monitoring purpose required.
Changelog
One entry per released pack version, newest first. `changed` and `added` list requirement ids whose text or obligations moved — the in-app review queue uses them to tell a user assessed under an older pack exactly which answers to re-read.
0.4.02026-08-30
Adds CE marking (Articles 29–30) as requirement P.6 — trivially satisfied, previously absent, and an assessor checks it first. Records limb-level applicability added to points (2)(c), (2)(l) and (2)(m) since 0.3.0, and introduces this changelog.
0.3.02026-07-31
Aligns the whole pack with the Official Journal text and Implementing Regulation (EU) 2025/2392: nearly every requirement's wording was revised against the adopted text, secure data erasure (point (2)(m)) was added as I.3m, and the decision tree carries the final Annex III/IV category lists. Assessments made under 0.2.0 should re-read every answer.
Added: I.3m. Changed: I.1, I.2, I.3a, I.3b, I.3c, I.3d, I.3e, I.3f, I.3g, I.3h, I.3i, I.3j, I.3k, II.1, II.2, II.3, II.4, II.5, II.6, II.7, II.8, P.1, P.2, P.3, P.4, P.5.
0.2.02026-07-27
Aligns with Commission guidance C(2026) 5252: adds the Art. 13(19) support-period disclosure duty as P.5 and revises when a vulnerability counts as known under point (2)(a).
0.1.02026-07-16
Initial pack: 25 requirements across Annex I Parts I and II and the Article 13/14 process obligations, with citations to the adopted regulation.
Vertical standards
The pack above is horizontal — the CRA obligations every product with digital elements carries. Where a product category gains a standard of its own, Vandorisk publishes a vertical pack alongside it, built and published the same way: rendered from the same JSON the engine evaluates, versioned, never silently edited.
Every ETSI CYBER-EUSR vertical standard is tracked below. 5 of the 14 repositories carried no published draft text when last verified (2 September 2026) — those rows say so plainly rather than invent requirements — and drafts integrate as ETSI publishes them.
| Standard | Title | Annex III item | Status |
|---|---|---|---|
| ETSI EN 304 617 | Browsers | Standalone and embedded browsers | Interim draft integrated |
| ETSI EN 304 618 | Password managers | Password managers | Interim draft integrated |
| ETSI EN 304 619 | Antivirus software | Software that searches for, removes, or quarantines malicious software | Announced — no text yet |
| ETSI EN 304 620 (Part 1) | Virtual private networks (Part 2 is announced with no published text yet) | Products with digital elements with the function of virtual private network (VPN) | Interim draft — integration pending |
| ETSI EN 304 621 | Network management systems | Network management systems | Interim draft integrated |
| ETSI EN 304 622 | Security information and event management | Security information and event management (SIEM) systems | Interim draft integrated |
| ETSI EN 304 623 | Boot managers | Boot managers | Interim draft integrated |
| ETSI EN 304 624 | PKI and digital certificate issuance software | Public key infrastructure and digital certificate issuance software | Interim draft integrated |
| ETSI EN 304 625 | Network interfaces | Physical and virtual network interfaces | Interim draft integrated |
| ETSI EN 304 626 | Operating systems | Operating systems | Interim draft integrated |
| ETSI EN 304 627 | Routers, modems and switches | Routers, modems intended for the connection to the internet, and switches | Announced — no text yet |
| ETSI EN 304 635 | Virtualisation and container execution systems | Hypervisors and container runtime systems that support virtualised execution of operating systems and similar environments | Announced — no text yet |
| ETSI EN 304 636 | Firewalls, intrusion detection and prevention systems | Firewalls, intrusion detection and prevention systems | Announced — no text yet |
| ETSI EN 4000X | Hardware devices with security boxes | Hardware Devices with Security Boxes | Announced — no text yet |
Corrections
This pack is maintained by Vandorisk. The regulation, the implementing regulation and the Commission’s guidance are the authoritative texts — the pack cites them, it does not replace them, and nothing on this page is legal advice.
If you find an error — a mis-cited provision, wording that has drifted from the Official Journal text, a scope note the implementing regulation does not support — write to hello@vandorisk.com. A correction ships as a new pack version with a changelog entry, never as a silent edit. See also how the product itself is run on the security page.