What CTOs Need to Know About the EU’s Cyber Resilience Act (CRA) – And Its Impact on Your SDLC

The EU’s Cyber Resilience Act rewrites software and device accountability in Europe – shifting security obligations firmly onto manufacturers, software publishers, and suppliers across the entire lifecycle. For CTOs, this is not a policy footnote but a product, engineering, and go‑to‑market imperative that touches governance, roadmaps, DevSecOps, vendor risk, and CE marking for market access. It also complements NIS2 and interacts with DORA, GDPR, and the forthcoming EU AI Act – demanding a single, integrated compliance architecture for regulated markets in the EU.

CRA – Quick facts CTOs can act on

Item What it means for your org
Entry into force 10 December 2024 – the law is in effect, with phased obligations
Full application 11 December 2027 – most obligations apply; CE‑marking for cybersecurity becomes market access critical
Early duties 11 September 2026 – manufacturers must start reporting actively exploited vulnerabilities and severe security incidents via national CSIRTs and ENISA
Scope “Products with digital elements” – hardware and software, directly or indirectly connectable; broad coverage with limited sectoral exclusions
Conformity path Baseline internal control for most; “important” and “critical” products face tighter routes – third‑party assessments and “substantial” assurance certification where applicable
Reporting clocks 24 hours early warning; 72 hours detailed update; final report within 14 days after a fix/mitigation is available
Penalties Up to €15m or 2.5% of global turnover (higher applies), with tiered fines and market surveillance powers to withdraw/recall products

 

Why the CRA matters now – beyond “security theater”

For years, security expectations were fragmented across directives and market norms. CRA harmonizes cybersecurity obligations across the EU’s internal market and makes them product‑lifecycle duties – from design to decommissioning – with CE‑marking as proof of conformity. It applies to nearly all products with digital elements made available in the EU, with specific exclusions for sectors already regulated, and signals clear complementarity with NIS2.

This is not only a compliance box. It fundamentally shifts SDLC priorities: secure‑by‑design and secure‑by‑default, vulnerability handling, update guarantees, incident/vulnerability reporting, and transparent documentation become table stakes for shipping into the EU from 2026–2027.

Scope – what’s in and what’s out

  • Applies to hardware, software, and combined products that connect logically or physically to devices or networks – directly or indirectly – and includes components that can themselves be placed on the market.
  • Exclusions include sectors already governed by dedicated product cybersecurity rules (e.g., certain medical, aviation, automotive domains) and specific carve‑outs around non‑commercial open‑source.
  • SaaS considerations – “remote data processing solutions” can fall in scope depending on qualification; expect scrutiny of how cloud elements relate to product security obligations.

Bottom line – if you ship a software or device product into the EU, assume coverage unless a specific sectoral regime governs you already.

Classification and conformity – how your product will be judged

CRA introduces a risk‑based lens: all products meet baseline requirements, while “important” and “critical” classes step up obligations. For certain “critical” products, third‑party conformity assessment and European cybersecurity certification at “substantial” assurance level will be expected; “important” Class I may use internal control if harmonized standards or certification are met, while Class II trends to third‑party. Conformity is evidenced through CE marking – increasingly interpreted by buyers as a trust signal for cybersecurity from December 2027.

Timelines and reporting – clocks your teams must operationalize

  • Main obligations apply from 11 December 2027 – budget, plan, and deliver across 2026–2027.
  • Early reporting obligations kick in from 11 September 2026 – set up the processes now.
  • When an actively exploited vulnerability or severe incident is discovered: early warning within 24 hours, a detailed vulnerability notification within 72 hours, and a final report within 14 days after mitigation is available – via ENISA/national CSIRTs.

These timelines require a practiced disclosure muscle, coordinated comms, and audit‑ready evidence trails.

Penalties and enforcement – risk you can quantify for the board

  • Top‑tier administrative fines up to €15 million or 2.5% of global annual turnover – higher applies – for failing essential cybersecurity requirements and reporting duties.
  • Additional tiers at €10m/2% and €5m/1% for other failures (e.g., technical documentation, misleading information) and market surveillance powers to withdraw, recall, or prohibit products.

Translate fines into deal risk: a non‑compliant product can be blocked or recalled at market surveillance authorities’ request – a GTM and revenue event, not just a legal one.

What the CRA requires across your SDLC – 12 concrete changes

1) Governance and ownership

  • Appoint a product cybersecurity owner with authority over SDLC controls, conformity evidence, and CE technical documentation.
  • Establish a cross‑functional “CRA Squad” – security, product, QA, legal, support, supply chain – meeting monthly to track readiness.

2) Threat modeling and risk assessment

  • Perform documented, regularly updated cyber risk assessments for each product – pre‑market and through maintenance – feeding requirements, tests, and mitigations.

3) Secure‑by‑design and secure‑by‑default

  • Enforce secure defaults, minimum necessary services, hardened configs, and the ability to return to a known secure state (e.g., rollback, factory reset).
  • Integrate static/dynamic analysis, dependency policies, and targeted pen tests as release gates.

4) Vulnerability handling process that’s operational on day one

  • Formalize coordinated vulnerability disclosure, public contact points, triage SLAs, and advisory publication.
  • Train teams on 24h/72h/14d reporting flows and build templates for ENISA/CSIRT submissions.

5) Update strategy and support commitments

  • Guarantee security updates for a defined support period – law‑firm guidance commonly interprets at least five years from market placing – and communicate the end‑of‑support date to users up front.

6) Dependency and component governance

  • Maintain accurate component inventories across builds. SBOMs are the pragmatic mechanism most teams will use to meet documentation and vulnerability‑tracking expectations and to accelerate zero‑day triage.

7) Technical documentation and CE file

  • Keep an audit‑ready technical file: risk assessment, design and controls, test evidence, update strategy, disclosure policy, user security information, and product identification – aligned to harmonized standards as they land.

8) Product labeling and user information

  • Provide clear product identification, manufacturer contact details, and support period end date – feeding customer security posture and post‑market obligations.

9) Supplier and open‑source due diligence

  • Flow down CRA‑aligned security and disclosure obligations to suppliers; vet repos, licensing, patch cadence, and provenance for open‑source dependencies.

10) Post‑market surveillance

  • Monitor exploit intel, customer incidents, and vulnerability feeds; tie to rapid response workflows and customer notification obligations.

11) Conformity assessment planning

  • Map each product to its risk class and conformity path. Where third‑party assessment or certification is likely, pre‑book capacity – 2027 bottlenecks are inevitable.

12) Market access and GTM

  • Treat CE‑marking for cybersecurity like safety CE – without it, distributors and importers will block listings and shelf space in the EU from December 2027.

How CRA fits with NIS2, DORA, and the EU AI Act – one operating model

 

  • CRA complements NIS2 – CRA hardens the product; NIS2 hardens the operator and essential/important entities. Align your controls and incident workflows to serve both, avoiding duplicate overhead.
  • If you’re a financial entity under DORA, leverage its ICT risk management, testing, and incident capabilities to meet CRA reporting and evidence needs.
  • For AI systems in scope of the EU AI Act, fold security‑by‑design and data governance into the same SDLC control set to avoid parallel pipelines.

A pragmatic CTO roadmap – 6 quarters to “CE‑ready”

  • Q1 – Portfolio and gap analysis
    • Classify products; map obligations; identify conformity routes; quantify risk and cost.
  • Q2 – Governance and pipelines
    • Stand up CRA Squad; instrument CI/CD with SAST/DAST/dependency checks; define disclosure and reporting SOPs.
  • Q3 – Controls and documentation
    • Run threat models; close high‑risk gaps; build the CE technical file skeleton; pilot security updates and rollback.
  • Q4 – Exercises and supplier alignment
    • Tabletop the 24h/72h/14d playbook; sign supplier addenda; establish SBOM practices and zero‑day routine.
  • Q5 – Pre‑assessment and harmonized standards
    • Dry‑run conformity against emerging harmonized standards and, where relevant, certification assurance level “substantial”.
  • Q6 – CE‑marking and launch readiness
    • Finalize documentation, labels, and user security info; pre‑book notified bodies or certification where needed; set post‑market monitoring.

Executive checklist – ask your teams today

  • Do we know each product’s CRA classification and conformity path? [Yes/No]
  • Can we evidence secure‑by‑design/default with tests and artifacts? [Yes/No]
  • Are the 24h/72h/14d reporting workflows rehearsed and templated? [Yes/No]
  • Do we have a documented support period and update strategy per product? [Yes/No]
  • Is our CE technical file structure defined and populated continuously? [Yes/No]
  • Are importers/distributors aligned on CE‑marking for cybersecurity by 11 Dec 2027? [Yes/No]

Summary

  • CRA is now in force, with early reporting from 11 September 2026 and full application from 11 December 2027 – plan for CE‑marking and documentation now.
  • Scope covers most products with digital elements; conformity tightens for “important” and “critical” classes, with third‑party or certification steps where applicable.
  • Reporting clocks are 24h/72h/14d to ENISA/national CSIRTs for actively exploited vulnerabilities and severe incidents – build and rehearse the playbook.
  • Penalties reach €15m or 2.5% of global turnover, plus withdrawal/recall powers – this is a GTM and revenue risk as much as a compliance one.
  • Treat CRA as a product and SDLC transformation – integrate with NIS2, DORA, and AI Act to create one operating model for EU‑grade resilience.