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Schwarzes Buch mit der Aufschrift EU Regulation neben Europa-Flagge
NIS 2 Regulation: How Midsize Companies Can Efficiently Meet the Requirements

The EU’s NIS 2 Directive poses one of the most significant challenges in recent years for midsize companies in Europe. NIS 2 demands not only extensive technical and organizational measures but also a cultural shift in how companies approach cybersecurity. For organizations handling sensitive design data, customer information, or production data, compliance with NIS 2 requirements is not optional – it’s mandatory and non-compliance may result in heavy fines and personal liability for management. But how can companies implement these complex requirements in a pragmatic and cost-efficient way?

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What Is the NIS 2 Regulation and Who Is Affected?

NIS 2 stands for “Network and Information Security Directive 2” and is an EU-wide regulation aimed at enhancing cybersecurity. It replaces the original NIS Directive, also known as NIS 1, and seeks to establish a high, uniform level of cybersecurity across the EU – especially in sectors that are socially and economically significant, including manufacturing, chemicals, food, mechanical engineering, research, and digital services.

Companies that fall under the scope of NIS 2:

  • Important Entities: Midsize companies with at least 50 employees or more than €10 million in annual revenue.

  • Essential Entities: Large enterprises with 250 or more employees or more than €50 million in annual revenue.

  • Even smaller businesses may be indirectly affected by NIS 2 due to requirements to ensure supply chain security.

The NIS 2 framework primarily applies to operators of Critical Infrastructures (KRITIS) and other businesses across various sectors. Companies in the financial, insurance, and healthcare sectors are not primarily affected, as the DORA regulation takes precedence over NIS 2 in these areas.

Is Your Company Affected by NIS 2?

Click on the image below to enlarge it and take the test.

NIS 2 Test for Affected Companies

When Does NIS 2 Take Effect?

Important dates at a glance:

  • Published in the EU Official Journal: December 27, 2022

  • Effective at EU level: January 16, 2023

  • Deadline for National Implementation by EU Member States: October 17, 2024

  • Implementation in Germany: March 2025 via the NIS 2 Implementation and Cybersecurity Strengthening Act (NIS2UmsuCG)

Key NIS 2 Requirements for Midsize Companies

NIS 2 mandates a broad range of measures that go well beyond traditional IT security. These include:

  • Risk Management: Systematic analysis and documentation of IT and cybersecurity risks

  • Technical & Organizational Measures: Implementation of Identity Governance & Administration (IGA), Identity & Access Management (IAM), Multi-Factor Authentication (MFA), encryption, and emergency response strategies

  • Supply Chain Security: Evaluating and securing IT environments of suppliers and partners

  • Incident Reporting: Fast and structured reporting of cybersecurity incidents to authorities

  • Accountability: Clear assignment of cybersecurity responsibilities, including at the executive level

  • Auditing & Monitoring: Regular effectiveness reviews of measures, including external audits and certifications, e.g. ISO 27001 and NIS 2 certification

  • Documentation: Complete and audit-proof documentation of all security processes

In our NIS 2 webinar with KPMG, we discuss the requirements as well as implementation strategies, impact and risk analysis, governance, risk mitigation and reporting.

NIS 2 is a comprehensive Directive for improving cybersecurity across the EU. While it requires upfront investment, the mandated measures provide real protection against cyber threats.

Fraunhofer IESE

NIS 2 Implementation Checklist: A Step-by-Step Guide

For midsize companies without an in-house compliance team, NIS 2 can feel overwhelming. The following steps have proven effective in practice:

1. Assess Applicability

Determine whether your company is subject to NIS 2 based on headcount, revenue, and sector.

2. Conduct a Risk Analysis

Identify and evaluate your IT and cybersecurity risks.

3. Evaluate Existing Measures

Identify gaps in your current security setup.

4. Prioritize Measures

Categorize initiatives by urgency, complexity, and resource needs.

5. Assign Responsibility

Appoint individuals responsible for cybersecurity and compliance.

6. Build Documentation

Record all measures and processes in an audit-ready manner.

7. Raise Awareness

Provide regular cybersecurity and compliance training.

8. Commit to Continuous Improvement

Review and adapt your controls as needed.

Tip: Use NIS 2-compliant software tools like the Garancy Suite to efficiently manage identity governance, access control, and documentation.

Business Pain Points: How to Minimize Effort and Costs

Many companies are concerned about the high investment and resource demands of NIS 2 compliance. The good news: With the right strategy and tools, both can be significantly reduced.

How to address common challenges:

  • Automation: Modern IGA and IAM platforms automate user and permission management, audit trails, and reporting

  • Centralized Platform: A solution such as the Garancy Suite consolidates compliance processes, reduces interfaces, and minimizes errors.

  • Phased Implementation: Prioritize high-risk items to allocate resources efficiently.

  • External Consulting: Bring in NIS 2 specialists to close knowledge gaps and leverage best practices.

  • Funding Opportunities: Explore government funding programs, free checking tools or webinars.

Liability Risks and Penalties: What Happens If You Don’t Comply?

The NIS 2 legislation imposes severe sanctions: fines up to €10 million or 2% of global revenue for essential entities and up to €7 million or 1.4% of global revenue for important entities. Executives may be personally liable for non-compliance.

NIS 2 and “Made in Europe” – Compliance as a Future-Proofing Strategy

The NIS 2 regulation is more than just a legal requirement – it’s an opportunity to strengthen your company’s digital resilience, secure its capacity for innovation, and establish trust in the European market. In a global environment with increasing protectionism – as, for instance, in the U.S. – “Made in Europe” is becoming a strategic asset, especially in the broader context of regaining digital sovereignty.

Turn NIS 2 Compliance Into a Competitive Advantage

Yes, NIS 2 demands a lot from midsize companies – but it also helps elevate your IT security and compliance to the next level. With a solid strategy, modern tools like the Garancy Suite, and a step-by-step approach, you can implement NIS 2 efficiently – and protect your business from liability and cyber threats for the long term.

Let Us Help You with Your NIS 2 Strategy

Are you curious how your company can implement NIS 2 pragmatically and with minimal resources? Get in touch with our IAM experts and receive actionable insights for your NIS 2 strategy!

Frequently Asked Questions

Yes, if your business has more than 50 employees or over €10 million revenue and operates in a relevant sector.

Risk analysis, technical and organizational controls, documentation, incident reporting, supply chain security, and more.

You may face substantial fines and personal liability for the executive team.

Assess NIS 2 applicability, run a risk analysis, prioritize actions, assign responsibility, and build documentation.

Essential entities are large enterprises with at least 250 employees, or over €50 million in annual revenue. Important entities are midsize companies with at least 50 employees, or over €10 million in annual revenue. Requirements are similar, but penalties for non-compliance differ.

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Author

Beta Systems Mitarbeiter Phillip Paul
Phillip Paul
Product Manager

Tags

ComplianceIAMIT SecurityNIS

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