General Counsel

May 02, 2025

6 min. read

NIS2 directive regulations and implementation in Italy

Share:

NIS2 directive regulations and implementation in Italy

When Italy formally enacted its updated cybersecurity legislation in October 2024, the impact rippled far beyond IT departments. I remember the buzz around Legislative Decree n. 138—dubbed the “Decreto NIS”—not just for its breadth, but for its signal: digital operational resilience had graduated from a technical ideal to a legal imperative. As the EU’s NIS2 directive reshapes cyber governance across member states, Italy’s transposition brings sweeping changes that extend well beyond critical infrastructure. Medium-sized manufacturers, public administrations, and cloud providers are all now in scope.

This article unpacks the key elements of the Italy NIS2 implementation, including the legislative timeline, industry impact, new compliance expectations, and how companies can act proactively.

Key takeaways from Italy’s NIS2 journey

Italy’s transposition of the NIS2 directive is now legally binding under Legislative Decree 138/2024. The Agenzia per la Cybersicurezza Nazionale (ACN) leads the enforcement effort, extending obligations to over 12,000 entities—up from fewer than 1,000 under the prior NIS1 framework.

The following table summarizes where things currently stand.

Overview of NIS2 Italy transposition status (April 2025)

ThemeStatus description
Transposition lawDecree 138/2024 fully implements NIS2 and repeals previous 2018 legislation. Effective from 16 Oct 2024.
TimelineKey milestones span Feb 2024 – May 2025, including self-assessments, registrations, and nominations of cyber contacts.
Scope expansionCoverage expands from ~900 to ≈12,000 entities, affecting sectors such as manufacturing, health, public administration, and digital services.
Entity classificationSoggetti essenziali (EE) and soggetti importanti (EI), based on staff and turnover thresholds.
SanctionsFines up to €10 million or 2% of turnover (EE), and €7 million or 1.4% (EI). ACN enforces in stages.
Reporting obligationsPre-alert in 24 hours, full report in 72 hours, and final report within a month to CSIRT-Italia.
Lead authorityACN acts as the national NIS authority, working with CSIRT-Italia and sector regulators.
Public sector scopeApplies to all central ministries, regions, and cities over 50,000 residents. Subject to corrective orders, not monetary fines.

As the legal foundation settles, attention now turns to deadlines.

Important dates and compliance milestones

Italy’s legislative process for NIS2 Italy transposition began with Delegation Law 15/2024, giving the government authority to draft and implement the EU directive. Since then, several regulatory and procedural deadlines have shaped the compliance landscape.

The table below captures this evolving timeline:

TItaly NIS2 directive implementation timeline

DateMilestoneStatus
17 Jan 2023NIS2 enters into EU lawCompleted
21 Feb 2024Law 15/2024 published, authorizing transpositionCompleted
27 Aug 2024Draft decree submitted to ParliamentCompleted
4 Sept 2024Decree 138/2024 adoptedCompleted
1 Oct 2024Publication in the Official GazetteCompleted
16 Oct 2024Decree comes into forceCompleted
9 Dec 2024DPCM 221/2024 defines safeguard clause and exclusionsCompleted
31 Dec 2024Deadline for entity self-assessmentsUpcoming
Jan–Feb 2025Online registration on ACN portalUpcoming
31 Mar 2025Publication of essential and important entity list by ACNUpcoming
15 Apr 2025Cyber responsible contact to be nominatedUpcoming
31 May 2025First round of risk assessments and additional data submissionsUpcoming

With this structured roadmap, the onus now falls on organizations to prepare for significant operational changes.

Structure and responsibilities under the Italian decree

Italy’s NIS2 Italy directive transposition introduces both new governance responsibilities and stricter risk-management requirements. These are divided across six parts of the decree.

Key content in Decreto NIS structure

PartContent overview
Capo IDefinitions, entity criteria, sector codes (ATECO alignment).
Capo IINational governance; ACN confirmed as lead authority and EU liaison.
Capo IIIRisk management obligations: MFA, supply-chain security, policies, and continuity planning.
Capo IVIncident reporting: 24-hour alert, 72-hour full report, one-month follow-up.
Capo VEnforcement mechanisms: inspections, audits, and orders.
Capo VISanctions: fines, certifications suspension, mitigation factor considerations.

The decree also includes coordination clauses ensuring alignment with Perimetro di Sicurezza Nazionale Cibernetica (PSNC), avoiding redundancy between legal regimes.

Sanctions, liability, and enforcement mechanics

The ACN uses a progressive enforcement model, starting with corrective orders before levying fines. For soggetti essenziali, fines can reach €10 million or 2% of global turnover. For soggetti importanti, the ceiling is €7 million or 1.4%.

Executives are not immune. Failure to adopt proper cybersecurity strategies may trigger civil liability and removal orders by regulators. While public administrations can’t be fined, they face binding remediation demands and reputational exposure through public disclosures.

Sector-specific impacts and expectations

The expansion of scope under Italy NIS2 implementation is most visible in sectors previously outside or only loosely covered by NIS1. Medium-sized manufacturers, biomedical labs, and regional governments are now directly impacted.

Sector impact of Italy’s NIS2 directive

SectorChange vs. NIS1New obligations and challenges
ManufacturingNewly regulated if ≥ 50 FTE or €10m turnoverRisk audits, segmentation of OT/IT, playbooks, board engagement
Energy and utilitiesScope extended to medium DSOs, LNG, district heatingFull cyber programs, vulnerability disclosures, faster incident reporting
HealthCoverage now includes all medium-large hospitalsGovernance aligned with ISO 27001, clinician awareness, joint audits with Health Ministry
Digital infrastructureNow includes all providers regardless of size24/7 SOC, SBOMs, advanced monitoring, SecNumCloud-level controls
Financial servicesDORA is lex specialis, NIS2 applies to infrastructureTLPT every 3 years, vendor risk concentration policies
Public administrationAll large municipalities in scopeAppoint cyber lead, adopt ACN’s security controls; no fines but binding orders

ACN projects one-off compliance costs between €1 billion and €1.8 billion but anticipates funding synergies with EU digital programs.

What companies in Italy should focus on

Italian organizations must treat the Italy NIS2 directive as more than regulatory compliance—it’s a strategic imperative. Entities should immediately assess cyber maturity against Article 21 controls and initiate governance alignment.

Immediate actions for Italian organizations

Priority areaDescription
Self-assessmentMust be completed by 31 Dec 2024; key to determining classification (EE or EI).
RegistrationEntities must register on ACN’s platform between Jan and Feb 2025.
Reporting SOPsDraft and test response plans for 24 h/72 h/1-month incident reporting.
Executive accountabilityNominate a board-level cyber contact and prepare for mandatory training sessions.
Framework alignmentConsolidate compliance with GDPR, PSNC, and other cybersecurity programs to streamline obligations.

Early engagement with ACN and sector regulators can uncover sector-specific nuances, mitigate risks, and reduce long-term compliance costs.

Is your organization ready for Italy’s new cyber frontier?

The road to full NIS2 compliance in Italy is both clear and complex. What stands out is not just the breadth of sectors affected, but the depth of responsibility introduced—from top-level board accountability to highly structured reporting and governance. Organizations that approach this strategically, by embedding cybersecurity into their culture and structure, will not only avoid penalties but position themselves for resilience in an increasingly digital economy.

Whether you’re in aerospace, energy, or municipal government, the time to act is now. Italy has defined the path—how you walk it is up to you.

Automate Your Cybersecurity and Compliance

It's like an in-house cybersecurity & compliance team for a monthly subscription! No prior cybersecurity or compliance experience needed.

Share this article

Post on Linkedin
Post on Facebook
Post on X

How useful was this post?

0 / 5. 0

General Counsel

He is regulatory compliance strategist with over a decade of experience guiding fintech and financial services firms through complex EU legislation. He specializes in operational resilience, cybersecurity frameworks, and third-party risk management. Nojus writes about emerging compliance trends and helps companies turn regulatory challenges into strategic advantages.
  • DORA compliance
  • EU regulations
  • Cybersecurity risk management
  • Non-compliance penalties
  • Third-party risk oversight
  • Incident reporting requirements
  • Financial services compliance

Explore further