EU compliance for SaaS companies refers to the set of regulatory obligations (including GDPR, NIS2, DORA, the AI Act, and the European Accessibility Act) that software and technology companies must satisfy to lawfully operate in the European market, protect EU user data, and avoid penalties reaching up to 7% of global turnover.
The European Union is the world's most regulated digital market — and the most lucrative. With over 450 million consumers, a GDP of EUR 16.6 trillion, and enterprise buyers who increasingly demand regulatory compliance as a procurement prerequisite, the EU represents enormous opportunity for SaaS and tech companies. But that opportunity comes with a regulatory stack that can overwhelm even experienced compliance teams.
GDPR, NIS2, DORA, the AI Act, and the European Accessibility Act — five major regulations, each with its own scope, timeline, and penalty structure. This playbook cuts through the complexity with a practical, step-by-step approach designed for non-EU tech companies entering the European market and EU-based companies scaling their compliance programmes.
Quick Reference
Details
Regulations covered
GDPR, NIS2, DORA, AI Act, European Accessibility Act
Primary audience
SaaS companies, tech companies, non-EU companies serving EU customers
Compliance timeline
90-day foundational plan (see roadmap below)
Maximum penalty exposure
Up to EUR 35 million or 7% of global turnover (AI Act)
Key principle
Compliance = competitive advantage, not just risk mitigation
EU Representative required
Yes, if processing EU personal data without EU establishment
Certifications that accelerate deals
ISO 27001, SOC 2 Type II, ISO 42001
Key Takeaways
Five EU regulations form the core compliance stack for tech companies: GDPR, NIS2, DORA, AI Act, and the European Accessibility Act
GDPR applies to any company processing EU residents' personal data — regardless of where the company is headquartered
Non-EU SaaS companies must appoint an EU Representative under GDPR Article 27 if they have no EU establishment
NIS2 expanded cybersecurity obligations to cover cloud providers, SaaS platforms, and managed service providers since October 2024
The AI Act is now fully in force for high-risk systems — companies deploying AI in the EU must classify and manage AI risk
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Demonstrable compliance accelerates enterprise sales cycles by 40–60% and is increasingly a procurement prerequisite
A structured 90-day roadmap can bring a tech company from zero to foundational compliance across all applicable regulations
SaaS compliance is not a one-time project — build continuous compliance operations from day one
The EU's digital regulation strategy is built on a simple principle: the more impactful the technology, the more obligations it carries. Understanding how these regulations interact is the first step toward efficient compliance.
The Five Pillars of EU Tech Regulation
Regulation
Full Name
In Force Since
Scope
Max Penalty
GDPR
General Data Protection Regulation
May 2018
Personal data protection
EUR 20M or 4% of global turnover
NIS2
Network and Information Security Directive
Oct 2024
Cybersecurity for essential/important entities
EUR 10M or 2% of global turnover
DORA
Digital Operational Resilience Act
Jan 2025
ICT risk in financial services
1% of average daily global turnover
AI Act
Artificial Intelligence Act
Phased 2025–2027
AI systems on EU market
EUR 35M or 7% of global turnover
EAA
European Accessibility Act
Jun 2025
Digital accessibility for B2C products/services
National penalties (vary by member state)
Why Compliance Is a Competitive Advantage
EU compliance is often framed as a cost centre. In practice, it's the opposite for companies that approach it strategically:
Faster enterprise sales — 78% of European enterprise buyers require compliance evidence before contract signature (Gartner, 2025). Prepared companies close 40–60% faster.
Higher deal values — Compliant vendors command 10–15% price premiums in regulated sectors like finance and healthcare.
Market differentiation — In crowded SaaS categories, compliance certifications (ISO 27001, SOC 2) are decisive differentiators.
Reduced risk — Systematic compliance practices prevent incidents that cost 5–10x more than prevention.
Investor confidence — VCs and PE firms increasingly require regulatory due diligence; compliance-ready companies attract better terms.
The bottom line: Don't think of EU compliance as the cost of entering Europe. Think of it as the price of admission to the most demanding — and most valuable — enterprise market in the world.
Which Regulations Apply to You?
Use this decision matrix to determine which EU regulations apply to your company:
Your Activity
GDPR
NIS2
DORA
AI Act
EAA
Process personal data of EU residents
Yes
—
—
—
—
Provide cloud/SaaS/managed IT services
Likely
Yes (if >50 employees or >EUR 10M turnover)
—
—
—
Serve the financial sector (banks, insurers, investment firms)
Likely
Yes
Yes
—
—
Develop or deploy AI systems in the EU
Likely
—
—
Yes
—
Offer B2C digital products/services
Likely
—
—
—
Yes
Operate online marketplaces or search engines
Likely
Yes
—
Possibly
Yes
Provide data centre or DNS services
Likely
Yes
—
—
—
Typical Profiles
Company Type
Applicable Regulations
Priority Order
B2B SaaS (general)
GDPR, NIS2
GDPR → NIS2
B2B SaaS (financial clients)
GDPR, NIS2, DORA
GDPR → DORA → NIS2
B2C SaaS / app
GDPR, NIS2, EAA
GDPR → EAA → NIS2
AI-powered SaaS
GDPR, NIS2, AI Act
GDPR → AI Act → NIS2
Fintech
GDPR, NIS2, DORA, possibly AI Act
GDPR → DORA → AI Act → NIS2
Infrastructure / cloud provider
GDPR, NIS2, possibly DORA
GDPR → NIS2 → DORA
First step, always: Conduct an inventory — what data do you collect, what systems do you operate, who are your customers, and what AI do you use? The inventory determines your regulatory profile.
GDPR: The Foundation of EU Compliance
Regulation (EU) 2016/679 is the most broadly applicable EU regulation and the one most non-EU companies encounter first. If you process personal data of anyone in the EU, GDPR applies to you — regardless of where your company is headquartered.
Core GDPR Obligations
Obligation
Requirement
Deadline/SLA
Lawful basis
Document a legal basis for every processing activity
Before processing begins
Transparency
Clear, accessible privacy notice in plain language
Maintain Article 30 records of all processing activities
Continuously updated
Security measures
Appropriate technical and organisational controls
Ongoing
Breach notification
Notify supervisory authority of personal data breaches
72 hours from awareness
Data Protection Impact Assessment
Conduct DPIA for high-risk processing
Before processing begins
EU Representative
Appoint representative if no EU establishment (Article 27)
Before offering services to EU
Data Protection Officer
Appoint DPO if required (public body, large-scale monitoring, special category data)
Before processing begins
Six Lawful Bases for Processing
Basis
When It Applies
Common SaaS Use Case
Consent
Individual freely gives informed, specific agreement
Marketing emails, analytics cookies
Contract
Processing necessary to perform a contract
Account creation, service delivery
Legal obligation
Required by EU or member state law
Tax records, employment law
Vital interests
Protect someone's life
Emergency health situations
Public task
Exercise official authority
Government services
Legitimate interest
Balancing test: business need vs. individual rights
Fraud prevention, security, direct marketing to existing customers
SaaS tip: Most product functionality relies on contract (Article 6(1)(b)). Marketing and analytics typically require consent or legitimate interest with a documented balancing test. Getting the lawful basis wrong is the #1 GDPR mistake for SaaS companies.
Data Transfers Outside the EU
If your company stores or processes EU personal data outside the EU (which most non-EU SaaS companies do), you need a valid transfer mechanism:
Transfer Mechanism
Description
Best For
Adequacy decision
EU Commission has determined the country provides adequate protection
US (via EU-US Data Privacy Framework), UK, Japan, South Korea, Canada, and others
Standard Contractual Clauses (SCCs)
Pre-approved contractual terms between data exporter and importer
Most common mechanism; works for any country
Binding Corporate Rules (BCRs)
Internal policies approved by supervisory authority
Large multinational groups
Transfer Impact Assessment (TIA)
Supplementary assessment when destination country laws may undermine SCCs
Required alongside SCCs where adequacy is uncertain
For US companies: The EU-US Data Privacy Framework (DPF) provides an adequacy decision for US organisations that self-certify with the US Department of Commerce. This is the simplest path, but requires active certification and compliance with DPF principles. For a deeper understanding of where data must reside and how sovereignty rules affect architecture decisions, see our Data Sovereignty in the EU Guide.
Can trigger investigations and escalated penalties
GDPR for US Companies: Special Considerations
US-based SaaS companies face unique GDPR challenges. This section addresses the most common questions and pitfalls.
Do You Need GDPR Compliance?
Yes, if any of these apply:
You have customers or users in the EU (even one)
Your website/app is accessible to EU residents and you offer goods or services to them
You monitor the behaviour of individuals in the EU (analytics, tracking, profiling)
You process data on behalf of an EU-based company (as a processor)
Common misconception: "We don't have an EU office, so GDPR doesn't apply." Wrong. GDPR applies based on the location of the data subject, not the location of the company.
EU Representative (Article 27)
If your US company processes EU personal data but has no EU establishment, you must appoint an EU Representative:
Aspect
Details
Who
A natural person or legal entity established in the EU
Where
Must be in a member state where data subjects are located
Role
Point of contact for supervisory authorities and data subjects
Liability
The representative can be subject to enforcement alongside the company
Cost
EUR 3,000–15,000/year depending on provider and complexity
Exceptions
Public authorities; occasional processing not including large-scale special category data
EU-US Data Privacy Framework
Requirement
Details
Self-certification
Register with US Department of Commerce
Annual re-certification
Must renew annually
Privacy policy updates
Must commit to DPF principles in privacy policy
Dispute resolution
Must provide accessible, independent recourse mechanism
FTC/DOT enforcement
Subject to enforcement by US authorities
Human rights redress
EU individuals can seek redress through Data Protection Review Court
Strategy for US SaaS companies: Self-certify under the DPF for the simplest transfer mechanism, and maintain signed SCCs as a backup in case the DPF faces another legal challenge (as happened with Privacy Shield in 2020).
NIS2: Cybersecurity Obligations
Directive (EU) 2022/2555 dramatically expanded the scope of EU cybersecurity obligations. Member states transposed it into national law by October 2024, and it now applies to a much broader range of companies than its predecessor.
Does NIS2 Apply to You?
NIS2 applies to essential entities and important entities in these sectors:
Digital infrastructure (IXPs, DNS, TLD registries, cloud, data centres, CDNs)
Digital providers (online marketplaces, search engines, social networks)
ICT service management (B2B managed services, managed security)
Research organisations
Public administration
Space
Size threshold: Generally applies to medium enterprises (50+ employees or EUR 10M+ turnover) and large enterprises. Some sectors have no size threshold (e.g., TLD registries, DNS providers).
Key NIS2 Obligations for SaaS Companies
Obligation
Details
Timeline
Risk management
Implement cybersecurity policies, risk analysis, and security measures
Ongoing
Incident reporting
Early warning within 24 hours, detailed report within 72 hours, final report within 1 month
Per incident
Supply chain security
Assess and manage risks from third-party suppliers and service providers
Senior management must approve security measures; personal liability for failures
Ongoing
Training
Cybersecurity awareness training for all staff, including management
Regular
NIS2 Penalties
Entity Type
Maximum Penalty
Essential entities
EUR 10 million or 2% of global annual turnover
Important entities
EUR 7 million or 1.4% of global annual turnover
Management liability
Personal liability for senior management; potential temporary bans
DORA: Digital Resilience for Financial Services
Regulation (EU) 2022/2554 on Digital Operational Resilience has applied in full since 17 January 2025. If you serve the financial sector, DORA likely applies to you.
Who Must Comply
Financial Entities
ICT Third-Party Providers
Banks and credit institutions
Cloud service providers serving financial entities
Investment firms
Data analytics platforms for financial services
Insurance and reinsurance companies
SaaS tools used by banks, insurers, or investment firms
Payment institutions
Managed IT service providers for financial sector
Crypto-asset service providers
Outsourced ICT infrastructure providers
Central counterparties
Software providers for trading, risk, or reporting
Due diligence, contractual requirements, concentration risk assessment
Exit strategies required for critical providers
Register of Information
Maintain detailed register of all ICT service provider arrangements
First submission: 30 April 2025
Information sharing
Participate in cyber threat intelligence sharing
Voluntary but encouraged
Critical for SaaS providers: If your customers include banks, insurers, or investment firms, they will flow DORA requirements down to you contractually. Expect requests for: incident notification SLAs, right-to-audit clauses, exit/transition planning, and Register of Information data.
DORA vs NIS2
Aspect
DORA
NIS2
Nature
Regulation (directly applicable)
Directive (transposed into national law)
Scope
Financial sector + their ICT providers
Cross-sector (essential + important entities)
Incident reporting
4 hours initial
24 hours early warning
Testing
TLPT required for significant entities
Risk-based testing
Relationship
Lex specialis — DORA takes precedence
Applies where DORA does not
AI Act: Artificial Intelligence Regulation
Regulation (EU) 2024/1689 on Artificial Intelligence is the world's first comprehensive AI law. Its obligations are phased in through 2027, with prohibited practices already in force and high-risk requirements applying from August 2026.
AI Act Risk Classification
Risk Level
Examples
Key Obligations
Effective Date
Prohibited
Social scoring, exploitative AI, real-time biometric ID in public spaces (with exceptions), emotion recognition at work/school
Must not deploy
2 Feb 2025 ✅
High risk
AI in recruitment, credit scoring, critical infrastructure, education, law enforcement, migration
Conformity assessment, risk management, human oversight, technical documentation, CE marking
Transparency — users must know they interact with AI
2 Aug 2025 ✅
Minimal risk
Spam filters, recommendation engines, most business software
No specific requirements; voluntary codes of conduct
N/A
GPAI (General-Purpose AI) Obligations
All providers of general-purpose AI models must:
Maintain technical documentation (training methodology, data sources, capabilities, limitations)
Provide adequate information to downstream deployers
Comply with EU copyright law and honour opt-out mechanisms
Publish training content summaries per AI Office template
GPAI models with systemic risk (>10^25 FLOP compute or Commission-designated) face additional obligations: model evaluations, systemic risk mitigation, incident reporting, and cybersecurity.
AI Act Penalties
Violation
Maximum Penalty
Deploying prohibited AI
EUR 35 million or 7% of global annual turnover
Non-compliance with high-risk requirements
EUR 15 million or 3% of global annual turnover
Providing incorrect information
EUR 7.5 million or 1.5% of global annual turnover
European Accessibility Act
Directive (EU) 2019/882 — full application from 28 June 2025. This regulation is often overlooked by tech companies but applies broadly to B2C digital products and services.
Who Must Comply
The EAA applies to companies offering these products and services to EU consumers:
Products
Services
Computers and operating systems
E-commerce websites and mobile apps
Smartphones, tablets
Banking services (ATMs, online banking)
TV equipment with interactive computing
Telephony and messaging services
E-book readers
Transport services (ticketing, real-time info)
Self-service terminals (ATMs, kiosks, check-in)
E-books and dedicated software
Key Requirements
Requirement
Standard
Details
Web accessibility
WCAG 2.2 Level AA
Perceivable, operable, understandable, robust
Mobile accessibility
WCAG 2.2 Level AA + platform guidelines
Native app accessibility features
Accessibility statement
Published and machine-readable
Conformance status, known issues, contact info
Feedback mechanism
Users can report accessibility barriers
Accessible contact method for issues
Documentation
Accessible product documentation
User guides, help content in accessible formats
Micro-Enterprise Exemption
Companies with fewer than 10 employees and annual turnover or balance sheet total not exceeding EUR 2 million may be exempt from service obligations — but only if compliance would cause disproportionate burden. The exemption must be documented and reassessed.
Regulation Comparison Matrix
This matrix helps you understand how the five regulations interact and overlap:
Aspect
GDPR
NIS2
DORA
AI Act
EAA
Type
Regulation
Directive
Regulation
Regulation
Directive
In force
May 2018
Oct 2024
Jan 2025
Phased 2025–27
Jun 2025
Scope
Personal data
Cybersecurity
Financial ICT resilience
AI systems
Digital accessibility
Applies to non-EU
Yes (extraterritorial)
Limited
Limited
Yes (extraterritorial)
Yes (if selling to EU consumers)
EU Representative
Required (Art. 27)
Not explicitly required
N/A
Required for non-EU providers
N/A
DPO / officer
DPO (if applicable)
CISO / responsible officer
ICT risk management function
AI compliance officer (recommended)
Accessibility officer (recommended)
Incident reporting
72 hours
24h / 72h / 1 month
4h / 72h / 1 month
Serious incident reporting (GPAI systemic risk)
N/A
Documentation
Records of processing, DPIA
Security policies, risk assessments
ICT risk framework, register of information
Technical documentation, conformity assessment
Accessibility statement
Certification
Not required (but helpful)
National schemes possible
N/A
CE marking (high-risk)
Self-declaration or testing
Max penalty
EUR 20M / 4%
EUR 10M / 2%
1% daily global turnover
EUR 35M / 7%
National (varies)
Where Regulations Overlap
Overlap Area
Regulations Involved
How to Handle
Security measures
GDPR + NIS2 + DORA
Implement once, document for each framework
Incident reporting
GDPR + NIS2 + DORA
Single incident process with regulation-specific notification paths
Risk assessment
All five
Unified risk methodology with regulation-specific modules
Vendor management
GDPR + NIS2 + DORA
Combined vendor assessment questionnaire
Documentation
All five
Central compliance documentation repository
Training
GDPR + NIS2 + DORA + AI Act
Integrated compliance training programme
Efficiency principle: Never build five separate compliance programmes. Build one integrated compliance framework with regulation-specific modules. This cuts cost by 40–60% and reduces operational friction.
The 90-Day Compliance Roadmap
This roadmap takes a tech company from zero to foundational compliance across all applicable EU regulations. Adjust scope based on your regulatory profile.
Phase 1: Discovery and Assessment (Days 1–20)
Step
Activities
Deliverables
Assemble the team
Appoint project lead; form cross-functional squad (product, legal, security, engineering); establish communication channels
Team charter, RACI matrix
Data inventory
Map all personal data: what you collect, where it's stored, how it flows, who processes it, lawful basis
Data flow map, processing inventory
AI inventory
Catalogue all AI/ML systems: purpose, data inputs, outputs, affected persons, provider
AI system register
Vendor inventory
List all vendors processing personal data or providing ICT services
Vendor register with risk tiers
Regulatory mapping
Determine which regulations apply based on inventories
Regulatory applicability matrix
Gap analysis
Compare current state against requirements for each applicable regulation
Gap assessment report with priority ranking
Claims audit
Review marketing, contracts, product copy for compliance claims that need substantiation
Audit findings and remediation list
Phase 2: Design and Documentation (Days 21–50)
Step
Activities
Deliverables
Privacy documentation
Privacy policy (English + local EU languages), Article 30 records, DPA template, DPIA for high-risk processing
Documentation package
Security framework
Cybersecurity policies, risk assessment methodology, incident classification, access control policies
Management approval of compliance programme; assignment of ongoing responsibilities
Signed compliance sign-off
Remember: 90 days gets you to foundational compliance. Full maturity — including ISO 27001 certification, SOC 2 Type II reports, and optimised processes — typically takes 12–18 months. Start the 90-day plan now and iterate.
Per-Regulation Compliance Checklists
GDPR Checklist
Identified all categories of personal data and processing purposes
Lawful basis documented for each processing activity
Privacy notice published (in relevant EU languages)
Records of Processing Activities (Article 30) maintained
Data Processing Agreements signed with all processors
Data subject request process in place (30-day SLA)
DPO appointed (if required: public body, large-scale monitoring, or special category data)
EU Representative appointed (Article 27) if no EU establishment
DPIA completed for high-risk processing activities
Resilience testing programme in place (TLPT every 3 years for significant entities)
Third-party risk management policy and due diligence procedures
Register of Information compiled and ready for submission
Exit strategies documented for critical ICT providers
Contractual requirements aligned with DORA Article 30
Concentration risk assessment for ICT providers
AI Act Checklist
Inventory of all AI systems in use or development
Risk classification for each system (prohibited / high / limited / minimal)
Prohibited AI practices verified and eliminated
Transparency measures for limited-risk systems (user disclosure)
Human oversight mechanisms for high-risk systems
Technical documentation for high-risk systems
Risk management system for high-risk systems (Article 9)
Data governance for high-risk systems (Article 10)
Registration in EU database where required
Conformity assessment completed (self or third-party for biometrics)
GPAI model documentation (if applicable)
Accessibility Checklist
WCAG 2.2 Level AA audit completed for web and mobile interfaces
Accessibility statement published (machine-readable preferred)
Remediation plan for identified issues with timelines
Feedback mechanism for users to report accessibility barriers
Ongoing accessibility testing incorporated into development workflow
Product documentation available in accessible formats
Compliance Cost Estimates
One of the most common questions from tech companies: "How much will this cost?" Here are realistic estimates based on company size and regulatory scope.
Cost comparison: The cost of compliance is a fraction of the cost of non-compliance. A single GDPR fine can exceed your entire compliance budget by 100x. More importantly, losing a major EU enterprise deal due to failed due diligence costs far more than the compliance investment.
Pro tip: Pre-populate answers in common questionnaire formats (SIG, CAIQ, VSAQ) and maintain a centralised response library. This cuts response time from weeks to days.
4. Publish Thought Leadership
Demonstrate ongoing regulatory awareness:
Quarterly compliance updates on your blog
Response to major enforcement actions and their implications
Guidance on how your product supports customer compliance
Participation in industry compliance forums and working groups
KPIs and Governance Cadence
Compliance KPIs
Track these metrics to measure and improve your compliance programme:
KPI
Target
Measurement
DSR response time
Median under 15 days (30-day legal maximum)
Track from request receipt to completion
Breach notification readiness
Under 120 minutes to draft regulator-ready notice (simulation)
Tabletop exercise results
DPIA completion time
Median under 12 days from feature concept to DPIA approval
Track per-feature
Access review completion
100% of privileged access reviews on schedule
Quarterly audit
Vendor DPA coverage
100% of data processors have signed DPAs
Vendor register audit
Training completion
100% of staff completed required training
LMS tracking
AI register freshness
100% of AI systems updated in last 90 days
Quarterly audit
Security questionnaire cycle time
Under 5 business days from receipt to completion
Track per-request
Accessibility score
WCAG 2.2 AA pass rate > 95%
Automated + manual testing
Monthly EU Governance Council
Hold a monthly governance meeting with representation from legal, security, product, and engineering:
Agenda Item
Purpose
Risk register review
Update risk assessments, add new risks, close resolved risks
Incident review
Analyse incidents and near-misses; identify systemic issues
New guidance, enforcement actions, legislative updates
Customer requirements
Emerging compliance demands from sales pipeline
KPI dashboard
Review all compliance metrics; flag items below target
Annual Activities
Activity
When
Who
Full regulatory mapping review
January
Legal + Compliance
ISO 27001 surveillance audit
Per certification schedule
Security + External auditor
SOC 2 Type II audit
Annually
Security + External auditor
Penetration test
Semi-annually
Security + External tester
DPIA review
Annually or after significant change
Privacy + Product
AI Act classification review
Annually or after new AI deployment
AI Governance + Legal
Accessibility audit
Annually
UX + External auditor
Comprehensive training refresh
Annually
All staff
Frequently Asked Questions
Do I need an EU legal entity to sell in Europe?
Not necessarily. GDPR requires a EU Representative (Article 27) if you process EU personal data without an EU establishment — this is a natural or legal person acting as your contact point, not a full subsidiary. NIS2, DORA, and the AI Act have their own applicability criteria. However, many companies find that establishing an EU entity (often in Ireland, Netherlands, or Croatia) simplifies compliance, builds customer trust, and provides commercial advantages. If you are considering hiring in Croatia specifically, our Employer of Record Croatia Guide covers the legal and operational requirements.
How long does compliance really take?
With focused effort, foundational compliance is achievable in 90 days. This means core documentation, essential technical controls, and the ability to respond to regulatory and customer inquiries. Full maturity — including certifications (ISO 27001, SOC 2), optimised processes, and comprehensive training — typically takes 12–18 months. Maintenance is an ongoing process; plan for quarterly reviews and annual audits.
Do I need separate compliance for each EU country?
No. GDPR, NIS2 (as implemented nationally), DORA, and the AI Act are EU-wide frameworks — the rules are substantially uniform. You build one compliance programme that covers the entire EU single market. National supervisory authorities handle enforcement, but one set of documentation and controls covers all 27 member states. Some variation exists in NIS2 national transpositions, particularly around registration requirements and specific sector thresholds.
What if I only have a few EU customers?
The number of customers does not determine applicability. GDPR applies based on offering goods or services to EU residents or monitoring their behaviour — even one EU user can trigger obligations. Similarly, the AI Act applies if your AI system is placed on the EU market or its output is used in the EU. The good news: compliance requirements scale with your processing activities, so a smaller EU footprint means simpler compliance.
Can I rely on my US SOC 2 for EU compliance?
SOC 2 Type II is valuable and demonstrates security maturity to EU buyers, but it does not replace EU-specific requirements. GDPR requires specific privacy controls (lawful basis, data subject rights, breach notification) that SOC 2 doesn't cover. NIS2 has its own risk management and reporting requirements. Use SOC 2 as a foundation, then layer EU-specific controls on top. Many companies pursue ISO 27001 as a more globally recognised standard.
What's the order of priority if I can't do everything at once?
Start with GDPR — it has the broadest applicability and the most aggressive enforcement history. Then address whichever regulation is most relevant to your customer base: DORA if you serve financial services, NIS2 if you're a significant digital provider, AI Act if you deploy AI systems. The European Accessibility Act should be addressed in parallel if you have B2C products. Always tackle the regulation your customers are asking about as a priority.
How does DORA interact with NIS2?
DORA is lex specialis to NIS2 — for financial entities and their ICT providers, DORA requirements take precedence where they overlap (particularly around incident reporting and risk management). If you serve both financial and non-financial customers, you'll need to comply with both: DORA for your financial sector obligations and NIS2 for your broader cybersecurity obligations. In practice, DORA is stricter, so meeting DORA requirements generally satisfies NIS2 as well.
Is it worth getting ISO 27001 certified?
For most SaaS companies selling to EU enterprises: yes, strongly recommended. ISO 27001 is the most widely recognised information security standard in Europe. It demonstrates systematic security management, satisfies many NIS2 and DORA requirements by proxy, and dramatically shortens security questionnaire responses. The investment (EUR 20,000–80,000 initially) typically pays for itself within 2–3 enterprise deals through faster sales cycles and reduced due diligence friction.
EU compliance is not a barrier to entry — it's your ticket to the most valuable enterprise market in the world. Companies that invest in systematic, demonstrable compliance close bigger deals faster, build deeper customer trust, and operate with the confidence that comes from knowing they've done it right.
Vision Compliance helps SaaS and tech companies navigate the EU regulatory landscape, from initial regulatory mapping through full compliance programme implementation. For help selecting the right advisory partner, see our guide to the best EU compliance firms. Whether you need a 90-day launchpad or a comprehensive multi-regulation programme, our team brings the cross-functional expertise — legal, technical, and operational — that effective compliance demands.
This guide reflects EU regulations as of February 2026. For company-specific compliance advice, consult with qualified legal and technical professionals. Official regulation texts are available on EUR-Lex.
Robert Lozo, mag. iur., is a Partner at Vision Compliance specializing in EU regulatory compliance. He advises organizations on GDPR, NIS2, AI Act, and financial regulation, delivering audit-ready documentation and compliance roadmaps across regulated industries.
