Pillar guide
DevSecOps for regulated EU enterprises
Between 2024 and 2027, European software teams inherited three overlapping bodies of law that all reach into the same place: how you build, test, document and maintain software. This guide is about what they actually require of an engineering organization — and what to do first.
Gabriel Chávez Díaz · Founder & CEO, Sprita iT
Last reviewed 14 August 2026 · 12 min read
What actually changed in Europe
European regulation moved software security from a best practice to a documented obligation. NIS2, DORA and the Cyber Resilience Act each require organizations to manage risk in the software they build and consume, and — critically — to be able to show evidence that they do.
The shift is not that Europe suddenly cares about secure code. It is that three separate instruments now expect the same thing from different angles: a defensible, repeatable process across the software lifecycle, with an audit trail. The engineering consequence is concrete — findings need owners, gates need policies, and dependencies need inventories.
The second shift is accountability. Under Directive (EU) 2022/2555, management bodies of in-scope entities are expected to approve and oversee cybersecurity risk-management measures. Security stopped being something delegated entirely downward, which is why these conversations now start in the boardroom and arrive at your backlog.
Three regulations, one engineering problem
NIS2 — risk management and supply chain
Directive (EU) 2022/2555 requires essential and important entities to take appropriate technical, operational and organisational measures to manage risks to their network and information systems. Two of the listed measure areas land squarely on software teams: supply chain security, including the security of relationships with direct suppliers; and security in acquisition, development and maintenance of network and information systems, including vulnerability handling and disclosure.
NIS2 is a directive, which means it becomes law through each Member State's transposition. Practical consequence: the obligations you face in Estonia, Germany or Spain derive from national law, and the detail differs — but the software controls converge.
DORA — operational resilience for finance
Regulation (EU) 2022/2554 applies directly to financial entities and to the ICT third-party providers that serve them. It requires an ICT risk management framework, incident classification and reporting, digital operational resilience testing, and structured management of ICT third-party risk. For software organizations, the practical reading is: your development and testing practices, vulnerability management and dependency governance are now in scope of financial supervision — either directly, or through your clients.
Cyber Resilience Act — product security and SBOM
Regulation (EU) 2024/2847 takes a product angle: it sets essential cybersecurity requirements for products with digital elements placed on the EU market, covering both the security properties of the product and the manufacturer's vulnerability handling processes across the support period. It is the instrument that puts a software bill of materials — machine-readable, covering at minimum top-level dependencies — into European law, and it introduces obligations to report actively exploited vulnerabilities.
The timeline is staged, and the reporting obligations arrive first. The Regulation entered into force on 10 December 2024; the rules on conformity assessment bodies apply from 11 June 2026; the vulnerability and incident reporting obligations under Article 14 apply from 11 September 2026 — a 24-hour early warning and a 72-hour notification to ENISA and the relevant CSIRT; and the main body of requirements applies from 11 December 2027. For most manufacturers, 11 September 2026 is the first hard deadline, and it is imminent. The CRA briefing has the full timeline.
The controls all three converge on
Read together, NIS2, DORA and the CRA ask for six engineering capabilities: know what you ship, find weaknesses early, prioritize by real risk, fix with ownership, protect the build, and keep the record.
- Component inventory. A current, machine-readable inventory of what your software is made of — see CycloneDX SBOM standard for the format most European buyers now request. This is the foundation for every other control; you cannot govern what you have not enumerated. How we establish it.
- Early detection in the lifecycle. Static analysis and dependency scanning where developers work, mapped to a recognised taxonomy such as OWASP Top 10 project. SAST and code quality.
- Risk-based prioritization. Regulators expect proportionality, not a flat backlog of every scanner finding. Reachability and business impact are what turn 1,000 findings into a defensible short list.
- Vulnerability handling with ownership. Named owners, target dates, and a documented path from discovery to fix — explicitly referenced in NIS2's measure areas and in the CRA's process requirements.
- Build and pipeline integrity. Protecting the process that produces the artifact, not just the artifact. Supply-chain Levels for Software Artifacts is the most useful public framework for reasoning about provenance levels.
- Evidence. Scope, method, findings, decisions and outcomes, written so someone outside your team can follow them. NIST SP 800-218 remains the clearest public articulation of secure development practices to map your controls against.
Evidence: what an auditor actually asks for
The gap that sinks most programmes is not detection — it is narrative. Teams can produce a dashboard; they cannot produce a defensible account of why the dashboard looks like that. In practice, four artifacts do most of the work:
- Scope and method statement. What was analysed, with what technique, over what period, and what was deliberately out of scope. Auditors trust a documented limitation far more than an unexplained gap.
- Findings register with decisions. Not just the issues, but what you decided about each one and why — including accepted risks with an approver.
- Remediation record. Evidence that the process completed: fixes, dates, verification.
- Control narrative. A plain-language mapping from your engineering practice to the control the regulation expects. What we produce for auditors.
One caution worth stating plainly: no consultancy and no tool can certify your compliance. Certification decisions sit with you, your auditors and, where relevant, your notified body. Anyone promising otherwise is describing something that does not exist.
A 90-day implementation sequence
The order matters more than the speed. This is the sequence we use, and it front-loads the two things that unblock everything else: knowing your estate, and getting developers to trust the signal.
Days 1–30: baseline and inventory
- Enumerate repositories, services and the products they compose — including the legacy nobody wants to open.
- Establish a component inventory and generate a first SBOM.
- Run a baseline analysis across code, dependencies, secrets and infrastructure as code. Measure noise honestly.
- Map your regulatory exposure: which instruments, via which entity, through which contracts.
Days 31–60: signal quality and ownership
- Tune rulesets to your stack until the false-positive rate is defensible to the engineers who receive the findings.
- Introduce analysis in pull requests in observation mode — nothing blocks yet.
- Assign ownership for material findings and agree remediation SLAs with engineering leadership.
- Start the evidence trail from day one; reconstructing it later is the expensive path.
Days 61–90: gates and governance
- Enforce blocking only for the risk classes your teams have agreed to, with a documented exception path.
- Establish dependency governance: approved sources, update policy, review triggers.
- Produce the first control narrative and review it with whoever owns compliance.
- Set the cadence: what gets reviewed monthly, what gets reported quarterly, who signs.
See the gate progression and deliverable structure in detail.
Five mistakes that cost European teams a year
- Buying tools before scoping obligations. Licences get renewed annually; the wrong ones get renewed twice before anyone admits it.
- Enforcing gates on day one. Blocking a release with an untuned ruleset is the fastest way to have security permanently disabled by the people who ship.
- Treating SBOM as a document. An inventory generated once for an audit is a snapshot of a system that changed the following week. It has to be continuous or it is theatre.
- Ignoring the legacy estate. COBOL, RPG and ABAP cores are usually where the material risk and the regulatory exposure actually live — and they are excluded from most modern tooling by default.
- Leaving evidence to the end. Reconstructing twelve months of decisions in the four weeks before an audit costs more than having recorded them.
The legacy problem nobody budgets for
In European banking, insurance and public administration, the systems carrying the highest regulatory exposure are frequently the oldest — and most application security tooling silently does not cover them.
A scanner that supports Java, Python and TypeScript covers the part of your estate that was written recently. It does not cover the transaction core in COBOL, the RPG on the AS/400, or the ABAP customisations in your ERP — which is exactly where a regulator will ask about change control and vulnerability management.
This is why the refactor-versus-remediate decision is a compliance decision as much as an engineering one. If you are weighing it, the technical debt diagnosis exists to make that call on evidence — an operational risk index and a recovery-effort estimate — rather than on instinct.
Frequently asked questions
Does NIS2 apply to us if we only build software?
It depends on your sector and size, not on whether you write code. NIS2 covers essential and important entities in listed sectors — and ICT service management is one of them. Even when you are out of scope directly, you are very likely in scope indirectly: your regulated customers must manage supply chain security, so their obligations arrive at you through contracts and questionnaires.
What is the difference between NIS2, DORA and the Cyber Resilience Act?
NIS2 is a directive on cybersecurity risk management for essential and important entities, transposed into each Member State's national law. DORA is a regulation applying directly to financial entities and their ICT providers, focused on digital operational resilience. The Cyber Resilience Act is a regulation covering products with digital elements placed on the EU market, focused on product security and vulnerability handling. Many organizations are in scope of more than one.
Do we need an SBOM by law in the EU?
For products with digital elements in scope of the Cyber Resilience Act, the essential requirements include identifying and documenting components — a software bill of materials in a commonly used, machine-readable format covering at least top-level dependencies. Beyond the CRA, SBOMs are increasingly demanded contractually by enterprise buyers well before any legal deadline.
How long does it take to become audit-ready?
For a mid-sized estate, a baseline assessment plus integrated analysis typically runs two to six weeks depending on portfolio size; building the governance and evidence trail that survives an audit is a programme, not a project. Anyone quoting a fixed compliance date without seeing your codebase is selling you something.
Can a tool make us compliant?
No. Tools produce findings; compliance requires demonstrable process — scope, prioritization rationale, ownership, remediation, and a record that it happened. That is why we produce technical evidence and control narratives and are explicit that certification decisions remain with you and your auditors.
Primary sources
- Directive (EU) 2022/2555 — NIS2 Directive. EUR-Lex, Official Journal of the European Union.
- Regulation (EU) 2022/2554 — DORA. EUR-Lex, Official Journal of the European Union.
- Regulation (EU) 2024/2847 — Cyber Resilience Act. EUR-Lex, Official Journal of the European Union.
- NIST SP 800-218 — NIST Secure Software Development Framework. NIST.
- OWASP Top 10 project — OWASP Top 10. OWASP Foundation.
- CycloneDX SBOM standard — CycloneDX. OWASP Foundation / Ecma International.
- Supply-chain Levels for Software Artifacts — SLSA. OpenSSF.
We link legal texts and standards directly. This page is informational and is not legal advice; obligations depend on your entity, sector and national transposition.
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