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Navigating the Storm: How NIS2 and DORA Are Redefining European Compliance

ClarySec team
14 min read

The EU’s NIS2 Directive and DORA Regulation are transforming cybersecurity compliance, demanding stricter risk management, incident reporting, and digital operational resilience. This guide breaks down their impact, shows their deep alignment with ISO 27001, and provides a practical, step-by-step path to readiness for CISOs and business leaders.

Introduction

The European compliance landscape is undergoing its most significant transformation in a generation. With the Network and Information Security (NIS2) Directive’s transposition deadline of October 2024 and the Digital Operational Resilience Act (DORA) becoming fully applicable in January 2025, the era of cybersecurity as a background IT function is definitively over. These two pieces of legislation represent a paradigm shift, placing cybersecurity and operational resilience at the heart of corporate governance and making management bodies directly accountable for failures.

For CISOs, compliance managers, and business owners, this isn’t just another framework to map controls against. It’s a mandate for a top-down, risk-based, and provably resilient security posture. NIS2 expands the scope of its predecessor to cover a vast range of “essential” and “important” entities, while DORA imposes stringent, harmonized rules on the entire EU financial sector and its critical technology providers. The stakes are higher, the requirements are more prescriptive, and the penalties for non-compliance are severe. This article will serve as your guide through this new terrain, leveraging the ISO 27001 framework as a practical foundation for achieving compliance with both NIS2 and DORA.


What’s at Stake

The consequences of failing to meet NIS2 and DORA obligations extend far beyond a slap on the wrist. These regulations introduce significant financial penalties, personal liability for leadership, and the risk of severe operational disruption. Understanding the gravity of these risks is the first step toward building a compelling business case for investment and organizational change.

NIS2, in particular, raises the financial stakes considerably. As our comprehensive guide, Zenith Controls, clarifies, the penalties are designed to command attention at the board level.

For essential entities, fines can reach up to €10 million or 2% of the total worldwide annual turnover of the preceding financial year, whichever is higher. For important entities, the maximum fine is €7 million or 1.4% of the total worldwide annual turnover.

These figures are comparable to GDPR-level penalties, signaling the EU’s intent to enforce cybersecurity standards rigorously. While harmonized at the EU level, the exact penalty structures may still vary slightly depending on how each Member State transposes NIS2 into national law. But the risk isn’t just financial. NIS2 introduces the potential for temporary bans on holding management positions for individuals found responsible for breaches, making cybersecurity a matter of personal accountability for CEOs and board members.

DORA, while focused on the financial sector, introduces its own set of pressures. Its primary goal is to ensure the continuity of critical financial services even during a significant ICT disruption. The risk here is systemic. A failure at a single financial entity or one of its critical ICT third-party providers could have a cascading effect across the European economy. DORA’s mandate is to prevent this by enforcing a high standard of digital operational resilience. The cost of non-compliance could mean not only fines but also the loss of operating licenses and catastrophic reputational damage in a sector built on trust.

The operational impact is equally daunting. Both regulations mandate strict incident reporting timelines. NIS2 requires an initial notification to competent authorities within 24 hours of becoming aware of a significant incident, with a more detailed report following within 72 hours. This compressed timeline puts immense pressure on incident response teams, requiring mature, well-rehearsed processes that many organizations currently lack. The focus is no longer just on containment and recovery, but on rapid, transparent communication with regulators.


What Good Looks Like

In this new era of heightened scrutiny, “good” is no longer about having policies on a shelf or achieving a point-in-time certification. It’s about embodying a state of continuous, provable operational resilience. It means shifting from a reactive, compliance-driven posture to a proactive, risk-informed culture where cybersecurity is woven into the fabric of the business. An organization that successfully navigates the NIS2 and DORA landscape will exhibit several key characteristics, many of which are rooted in the principles of a well-implemented Information Security Management System (ISMS) based on ISO 27001.

The ultimate goal is a state where the organization can confidently withstand, respond to, and recover from ICT disruptions while protecting its critical assets and services. This involves a deep understanding of the business processes and the technology that underpins them. As Zenith Controls outlines, the objective of these regulations is to create a robust digital infrastructure across the EU.

The primary objective of the NIS2 Directive is to achieve a high common level of cybersecurity across the Union. It aims to improve the resilience and incident response capacities of both the public and private sectors.

Achieving this “high common level” means implementing a comprehensive security program that covers governance, risk management, asset protection, incident response, and supplier security. A mature organization will have a clear line of sight from board-level risk appetite down to specific technical controls. Management won’t just sign off on the budget; they will actively participate in risk management decisions, as mandated by both NIS2 (Article 20) and DORA (Article 5).

This ideal state is defined by proactive, intelligence-led security. Instead of just reacting to alerts, the organization actively gathers and analyzes threat intelligence to anticipate and mitigate potential attacks. This aligns directly with ISO/IEC 27002:2022 Control 5.7 (Threat intelligence), a practice that is now an explicit expectation under both new regulations.

Furthermore, resilience is tested, not assumed. “Good” looks like an organization that regularly conducts realistic tests of its incident response and business continuity plans. For designated financial entities under DORA, this may extend to advanced Threat-Led Penetration Testing (TLPT), a rigorous simulation of real-world attack scenarios. Not every organization will be in scope, but for those that are, TLPT is a binding requirement. This culture of testing ensures that plans are not just theoretical documents but actionable playbooks that work under pressure.

Tying to ISO 27001:2022 Control Themes

ISO 27001:2022’s Annex A controls, as elaborated in ISO/IEC 27002:2022, form the backbone of a modern ISMS. As highlighted in the Zenith Controls: The Cross-Compliance Guide,

Controls such as A.5.7 (Threat Intelligence), A.5.23 (Information Security for Use of Cloud Services), and A.5.29 (Supplier Relationships) are directly referenced in both NIS2 and DORA implementation guidance, underscoring their centrality to cross-regulatory compliance. Organizations that fully implement and evidence these controls are well-positioned, but must still address the specific reporting, governance, and resilience mandates introduced by the new regulations.


The Practical Path: Step-by-Step Guidance

Achieving compliance with NIS2 and DORA can seem like a monumental task, but it becomes manageable when broken down into core security domains. By leveraging the structured approach of an ISO 27001-aligned ISMS, organizations can build the necessary capabilities systematically. Here’s a practical path forward, guided by established policies and best practices.

1. Establish Strong Governance and Accountability

Both regulations place ultimate responsibility on the “management body.” This means cybersecurity is no longer delegable to the IT department alone. The board must understand, oversee, and approve the cybersecurity risk management framework.

The first step is to formalize this structure. Your organization’s policies must reflect this top-down approach. According to the P01S Information Security Policies Policy - SME, a foundational document for any ISMS, the policy framework itself requires explicit endorsement from the top.

Information security policies shall be approved by management, published, and communicated to employees and relevant external parties.

It means management is actively involved in setting the direction. This is further reinforced by defining clear roles. The P02S Governance Roles & Responsibilities Policy - SME states that “Information security responsibilities shall be defined and allocated,” ensuring there is no ambiguity about who owns which aspect of the security program. For NIS2 and DORA, this must include a designated individual or committee responsible for reporting on compliance status directly to the management body.

Key Actions:

  • Assign a board-level sponsor for cybersecurity and resilience.
  • Schedule regular board reviews of ISMS performance and regulatory compliance.
  • Document decisions, actions, and evidence of oversight.

2. Implement a Comprehensive Risk Management Framework

Reassess and Update Your Risk Assessment Process As outlined in the Implementation Guide for Risk Assessment Methodology, “NIS2 and DORA require dynamic, threat-led risk assessments that go beyond static, annual reviews. Organizations must integrate threat intelligence (A.5.7) and ensure risk assessments are updated in response to changes in the threat landscape or business environment.” Zenith Controls. NIS2 goes beyond generic risk assessment by mandating concrete risk-management measures in Article 21, including supply chain security, incident handling, business continuity, and the use of cryptography. These requirements must be demonstrably implemented and regularly reviewed, making it clear that compliance is not just about documentation but about provable operational practices.

Key Actions:

  • Incorporate real-time threat intelligence into risk assessments.
  • Ensure risk assessments explicitly cover supply chain and ICT third-party risks (A.5.29).
  • Document and evidence the review and update process.

This process should be continuous and iterative, not an annual checkbox activity. It involves everything from supply chain security to employee awareness.

3. Enhance Incident Response and Reporting

The stringent reporting deadlines of NIS2 (24-hour initial notification) and the detailed classification and reporting scheme of DORA demand a highly mature incident management function. This requires more than just a SOC; it requires a well-defined and rehearsed plan.

The P30S Incident Response Policy - SME provides the blueprint for this capability. It emphasizes that “The organization shall plan and prepare for managing information security incidents by defining, establishing, and communicating information security incident management processes, roles, and responsibilities.” Incident response is a focal point of both NIS2 and DORA. The Information Security Incident Management Policy (Section 4.2) states:

Organizations must implement procedures to detect, report, and respond to incidents within the timelines required by applicable regulations, and maintain detailed records for audit purposes.

Key elements to implement include:

  • A clear definition of a “significant incident” that triggers the reporting clock for NIS2 and DORA.
  • Pre-defined communication channels and templates for reporting to regulators, CSIRTs, and other stakeholders.
  • Regular drills and tabletop exercises to ensure the response team can execute the plan effectively under pressure.
  • Post-incident review processes to learn from every event and continuously improve the response capability.

4. Bolster Supply Chain and Third-Party Risk Management

DORA, in particular, elevates ICT third-party risk management from a due diligence activity to a core operational resilience discipline. Financial entities are now explicitly responsible for the resilience of their critical ICT providers. NIS2 also requires entities to address risks arising from their suppliers.

The Third-Party and Supplier Security Policy, Section 5.2 - SME requires that:

Prior to engagement, each supplier must be reviewed for potentital risks.

It also outlines the necessary controls, stating that “The organization’s requirements for information security shall be agreed with suppliers and documented.” For DORA and NIS2, this goes further:

  • Maintain a register of all ICT third-party providers, with a clear distinction for those deemed “critical.”
  • Ensure contracts include specific clauses covering security controls, audit rights, and exit strategies. DORA is highly prescriptive on this front.
  • Conduct regular risk assessments of critical suppliers, not just during onboarding but throughout the relationship lifecycle.
  • Develop contingency plans for the failure or termination of a critical supplier relationship to ensure service continuity.

5. Build and Test for Resilience

Finally, both regulations are fundamentally about resilience. Your organization must be able to maintain critical operations during and after a cybersecurity incident. This requires a comprehensive business continuity management (BCM) program.

The Business Continuity and Disaster Recovery Policy - SME emphasizes the need to embed security into BCM planning. It states, “The organization shall determine its requirements for information security and the continuity of information security management in adverse situations.” This means your BCM and disaster recovery (DR) plans must be designed with cyber-attacks in mind. Key actions include:

  • Conducting Business Impact Analyses (BIAs) to identify critical processes and their recovery time objectives (RTOs).
  • Developing and documenting BCM and DR plans that are clear, actionable, and accessible.
  • Regularly testing these plans through realistic scenarios, including cyber-attack simulations. DORA’s requirement for Threat-Led Penetration Testing for designated entities is the pinnacle of this practice.

By following these steps and embedding them within an ISO 27001-aligned ISMS, organizations can build a defensible and effective compliance program that meets the high bar set by both NIS2 and DORA.


Connecting the Dots: Cross-Compliance Insights

One of the most efficient ways to tackle NIS2 and DORA is to recognize their significant overlap with existing, globally recognized standards, most notably the ISO/IEC 27001 and 27002 framework. Viewing these new regulations through the lens of ISO controls allows organizations to leverage their existing ISMS investments and avoid reinventing the wheel.

Zenith Controls provides critical cross-references that illuminate these connections, demonstrating how a single control from ISO/IEC 27002:2022 can help satisfy requirements from multiple regulations.

Governance and Policy (ISO/IEC 27002:2022 Control 5.1): The mandate for management body oversight is a cornerstone of both NIS2 and DORA. This aligns perfectly with Control 5.1, which focuses on establishing clear policies for information security. As Zenith Controls explains, this control is foundational for demonstrating leadership commitment.

This control directly supports NIS2 Article 20, which holds management bodies accountable for overseeing the implementation of cybersecurity risk-management measures. It also aligns with DORA Article 5, which requires the management body to define, approve, and oversee the digital operational resilience framework.

By implementing a robust policy framework approved and regularly reviewed by leadership, you create the primary evidence needed to satisfy these crucial governance articles.

Incident Management (ISO/IEC 27002:2022 Control 5.24): The demanding incident reporting requirements of both regulations are directly addressed by having a mature incident management plan. Control 5.24 (Information security incident management planning and preparation) provides the structure for this. The alignment is explicit:

This control is essential for compliance with NIS2 Article 21(2), which mandates measures for handling security incidents, and Article 23, which sets out strict incident reporting timelines. It also maps to DORA’s detailed incident management process described in Article 17, which includes classifying and reporting major ICT-related incidents.

A well-documented and tested incident response plan based on this control is not just good practice; it’s a direct prerequisite for NIS2 and DORA compliance.

ICT Third-Party Risk (ISO/IEC 27002:2022 Control 5.19): DORA’s intense focus on the supply chain is one of its defining features. Control 5.19 (Information security in supplier relationships) provides the framework for managing these risks. Zenith Controls highlights this critical link:

This control is fundamental for addressing the extensive requirements in DORA Chapter V on managing ICT third-party risk. It also supports NIS2 Article 21(2)(d), which requires entities to ensure the security of their supply chains, including relationships between each entity and its direct suppliers.

Implementing the processes described in Control 5.19, such as supplier screening, contractual agreements, and ongoing monitoring, builds the exact capabilities DORA and NIS2 demand.

Business Continuity (ISO/IEC 27002:2022 Control 5.30): At its heart, DORA is about resilience. Control 5.30 (ICT readiness for business continuity) is the ISO equivalent of this principle. The connection is direct and powerful.

This control is the cornerstone for meeting the core objective of DORA, which is to ensure business continuity and resilience of ICT systems. It directly supports the requirements outlined in DORA Chapter III (Digital Operational Resilience Testing) and Chapter IV (Managing ICT Third-Party Risk). It also aligns with NIS2 Article 21(2)(e), which mandates policies on business continuity, such as backup management and disaster recovery.

By building your BCM program around this control, you are simultaneously building the foundation for DORA compliance. This demonstrates that ISO 27001 is not just a parallel track but a direct enabler for meeting Europe’s new regulatory demands.

Quick View: ISO 27001 Annex A vs NIS2 vs DORA

DomainISO 27001:2022 ControlNIS2 ReferenceDORA Reference
Governance & PoliciesA.5.1Art. 20Art. 5
Incident ManagementA.5.24Arts. 21–23Art. 17
Supplier RiskA.5.19, A.5.29Art. 21(2)(d)Chapter V
Business ContinuityA.5.30Art. 21(2)(e)Chapter III–IV

This alignment shows how a single ISO control can help satisfy multiple regulatory demands, making ISO 27001 a direct enabler of NIS2 and DORA compliance.


Preparing for Scrutiny: What Auditors Will Ask

When regulators or auditors come knocking, they will be looking for tangible evidence of a living, breathing security and resilience program, not just a set of documents. They will probe for proof that your policies are implemented, your controls are effective, and your plans are tested. Understanding their focus allows you to prepare the right evidence and ensure your teams are ready to answer tough questions.

Guidance from Zenith Blueprint, an auditor’s roadmap, provides invaluable insight into what to expect. Auditors will systematically work through key domains, and you need to be prepared for each one.

Here is a checklist of what auditors will request and what they will do, based on their methodology:

1. Governance and Management Commitment:

  • What they’ll ask for: Board meeting minutes, risk committee charters, and signed-off copies of the main information security policies.
  • What they’ll do: As described in Zenith Blueprint’s “Phase 1, Step 3: Understand the Governance Framework,” auditors will “Verify that the management body has formally approved the ISMS policy and is regularly briefed on the organization’s risk posture.” They are looking for evidence of active engagement, not just a signature on a year-old document.

2. Third-Party Risk Management:

  • What they’ll ask for: A complete inventory of ICT suppliers, contracts with critical providers, supplier risk assessment reports, and evidence of ongoing monitoring.
  • What they’ll do: During “Phase 4, Step 22: Assess Third-Party Risk Management,” the auditor’s focus is on due diligence and contractual rigor. Zenith Blueprint notes the key evidence required: “Contracts, Service Level Agreements (SLAs), and audit reports from suppliers.” They will scrutinize these documents to ensure they contain the specific clauses mandated by DORA, such as rights to audit and clear security obligations.

3. Incident Response and Business Continuity Plans:

  • What they’ll ask for: Your incident response plan, business continuity plan, disaster recovery plan, and, most importantly, the results of your latest tests, drills, and simulations.
  • What they’ll do: Auditors will not just read your plans. As detailed in “Phase 3, Step 15: Review Incident Response and Business Continuity Plans,” their focus is on “Testing and validation of plans.” They will ask for after-action reports from tabletop exercises, penetration test results (especially TLPT reports for DORA), and evidence that findings from these tests were tracked to remediation. A plan that has never been tested is considered by an auditor to be a plan that does not exist.

4. Security Awareness and Training:

  • What they’ll ask for: Training materials, completion records for different employee groups (including the management body), and results from phishing simulations.
  • What they’ll do: In “Phase 2, Step 10: Evaluate Security Awareness and Training,” auditors will “Assess the effectiveness of the training program by reviewing its content, frequency, and completion rates.” They will want to see that the training is tailored to specific roles and that its effectiveness is measured.

Being prepared with this evidence in advance will transform an audit from a stressful, reactive scramble into a smooth demonstration of your organization’s maturity and commitment to resilience.


Common Pitfalls

While the path to NIS2 and DORA compliance is clear, several common pitfalls can derail even well-intentioned efforts. Being aware of these traps is the first step to avoiding them.

  1. The “IT-Only” Mindset: Treating NIS2 and DORA as a problem solely for the IT or cybersecurity department is the most common mistake. These are business-level regulations focused on operational resilience. Without buy-in and active participation from the management body and business unit leaders, any compliance effort will fail to address the core requirements of governance and risk ownership.

  2. Underestimating the Supply Chain: Many organizations have a blind spot when it comes to the true extent of their reliance on third-party ICT providers. DORA, in particular, requires a deep, exhaustive understanding of this ecosystem. Simply sending out a security questionnaire is no longer sufficient. Failing to properly identify all critical suppliers and embed robust security and resilience requirements into contracts is a major compliance gap.

  3. “Paper-Based” Resilience: Creating detailed incident response and business continuity plans that look great on paper but have never been tested in a realistic scenario. Auditors and regulators will see right through this. Resilience is proven through action, not documentation. A lack of regular, rigorous testing is a red flag that your organization is not prepared for a real crisis.

  4. Ignoring Threat Intelligence: Simply reacting to threats is a losing game. Both NIS2 and DORA implicitly and explicitly call for a more proactive, intelligence-led approach to security. Organizations that fail to establish a process for collecting, analyzing, and acting on threat intelligence will struggle to demonstrate they are managing risk effectively and will always be one step behind attackers.

  5. Treating Compliance as a One-Off Project: NIS2 and DORA are not projects with an end date. They establish an ongoing requirement for monitoring, reporting, and continuous improvement. Organizations that view this as a race to the deadline, only to scale back resources afterward, will quickly fall out of compliance and find themselves unprepared for the next audit or, worse, the next incident.


Next Steps

The journey to NIS2 and DORA compliance is a marathon, not a sprint. It requires a strategic, structured approach grounded in proven frameworks. The most effective way forward is to leverage the comprehensive controls of ISO 27001 as your foundation.

  1. Conduct a Gap Analysis: Start by assessing your current posture against the requirements of NIS2, DORA, and ISO 27001. Our flagship guide, Zenith Controls, provides the detailed mapping you need to understand where your controls meet the requirements and where gaps exist.

  2. Build Your ISMS: If you don’t already have one, establish a formal Information Security Management System. Use our suite of policy templates, such as the Full SME Pack - SME or Full Enterprise Pack, to accelerate the development of your governance framework.

  3. Prepare for Audits: Adopt an auditor’s mindset from day one. Use Zenith Blueprint to understand how your program will be scrutinized and to build the evidence base you need to demonstrate compliance confidently.


Conclusion

The arrival of the NIS2 Directive and the DORA Regulation marks a pivotal moment for cybersecurity and operational resilience in Europe. They are not merely incremental updates to existing rules but a fundamental reshaping of regulatory expectations, demanding greater accountability from leadership, deeper scrutiny of the supply chain, and a tangible commitment to resilience.

While the challenge is significant, it is also an opportunity. It is an opportunity to move beyond checkbox compliance and build a truly robust security posture that not only satisfies regulators but also protects the business from the ever-growing threat of disruption. By leveraging the structured, risk-based approach of ISO 27001, organizations can build a single, unified program that addresses the core requirements of both regulations efficiently and effectively. The path forward requires commitment, investment, and a top-down cultural shift, but the outcome is an organization that is not just compliant, but genuinely resilient in the face of modern digital threats.

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