Cyber threats have become an ever-present danger. From small startups to multinational corporations, no one is immune. Ransomware attacks are on the rise. Sensitive data leaks happen almost weekly. Nation-state hacking is no longer fiction, it’s a harsh reality. With such growing digital vulnerabilities, the global community is pushing for stronger cyber defenses and, more importantly, compliance with robust cybersecurity regulations.
One of the most important regulations in this space is the Cybersecurity Act of 2019. While lesser known compared to HIPAA or ISO 27001, this regulation plays a pivotal role in strengthening digital trust across the European Union. But what exactly is the Cybersecurity Act? Why should organizations handling ICT products and services take it seriously?
Let’s break it down.
What is the Cybersecurity Act of 2019?
The Cybersecurity Act of 2019 is a major legislative move by the European Union (EU) to improve its defenses against digital threats. It came into effect on June 27, 2019, as Regulation (EU) 2019/881, marking a significant step toward a unified and secure digital Europe.
Why was the Cybersecurity Act created?
The need for the Cybersecurity Act emerged from increasing incidents of cyber attacks targeting critical infrastructure, financial systems, cloud platforms, and IoT devices across Europe. The existing national standards made it difficult for companies to navigate compliance and for consumers to know which products were truly secure.
The EU realized that cybersecurity couldn’t be optional or isolated. A fragmented approach to digital security was no longer sustainable. A harmonized, pan-European strategy was essential.
How did it evolve?
Before 2019, ENISA operated under a temporary mandate, mostly in an advisory role. Meanwhile, organizations followed a patchwork of voluntary security frameworks and national-level certifications. This led to inconsistencies, high compliance costs, and widespread confusion.
The Cybersecurity Act brought clarity and structure:
- It made ENISA permanent, with expanded authority to assist EU member states, coordinate responses, and improve preparedness.
- It introduced a framework for EU-wide cybersecurity certifications, which allows businesses to certify the security of their ICT products, services, and processes at varying levels of assurance.
The Act supports the EU’s broader Digital Single Market strategy, encouraging cross-border trade and innovation while reinforcing digital security and consumer trust.
Unlike older cybersecurity acts that were often reactive, the Cybersecurity Act of 2019 is proactive. It focuses not just on responding to incidents but on building a security-first culture. It emphasizes certification, standardization, and long-term resilience.
This regulation set the tone for future legislation in the EU, including proposals for the Cyber Resilience Act, which aims to complement and build upon its foundation.
In short, the Cybersecurity Act of 2019 is a foundation for digital security in the EU and a signal to the world that cyber compliance is not optional.
Guidelines, best practices, and frameworks of the Cybersecurity Act of 2019
One of the most impactful features of the Cybersecurity Act of 2019 is its creation of a comprehensive cybersecurity certification framework. This is a structured, tiered system designed to build trust in digital technologies across the EU. Whether it’s a cloud service, smart home device, or a software platform, the Act provides a roadmap to prove its cybersecurity readiness.
The EU cybersecurity certification framework
The certification framework introduced by the Act focuses on evaluating the cybersecurity of ICT products, services, and processes through formal certification schemes. These schemes are voluntary (for now), but they play a huge role in strengthening the EU cybersecurity market and reducing uncertainty among consumers and businesses alike.
Each certification scheme includes:
- Defined security requirements
- Evaluation criteria
- Testing methods
- Issuance procedures
- Monitoring and oversight rules
The goal is to make sure every certified product or service meets a recognized level of cybersecurity assurance, providing peace of mind for buyers and users.
Three levels of assurance
The certification framework operates on a tiered model.
- Basic
- Focuses on protection against minimal risks.
- Suitable for lower-risk products or services.
- Requires limited testing and evaluation.
- Substantial
- Targets more significant cybersecurity threats.
- Involves structured assessment procedures.
- Requires conformity assessments by accredited bodies.
- High
- Reserved for critical systems or high-risk products.
- Requires intensive, independent evaluations and ongoing monitoring.
- Ideal for essential services, finance, health, or public infrastructure sectors.
This tiered model allows organizations to choose a level appropriate to their risk exposure and compliance goals.
Core principles and best practices
The Cybersecurity Act of 2019 also promotes several best practices that align with broader cybersecurity regulations and frameworks:
- Security-by-design and by-default: Products should be secure from the start and not just after deployment.
- Transparency: Certification details and criteria are published openly.
- Reusability of evidence: Certification components can be reused across schemes to reduce costs.
- Harmonization: Aims to replace fragmented national certification programs with a single, EU-wide approach.
While the Act is EU-specific, its framework aligns with global efforts to establish standardized cybersecurity regulations. Many of its principles echo ISO 27001, NIST CSF, and CIS Controls, making it easier for multinational organizations to map compliance efforts across jurisdictions.
Why should organizations care about the Cybersecurity Act of 2019?
In today’s digital-first economy, compliance is a strategic advantage. The Cybersecurity Act of 2019 offers a forward-looking, structured approach to cyber readiness, which can give organizations a competitive edge while helping them manage risks more effectively.
So why should your organization care about this particular cybersecurity act?
1. It builds customer and partner trust
Whether you’re offering cloud services, IoT devices, or enterprise software, customers want assurance that your products are secure. The EU cybersecurity certification provides exactly that.
- Certified products demonstrate that they meet clearly defined cyber security regulations.
- It’s easier to win contracts, especially with government bodies or large enterprises that prioritize compliance.
- It gives potential partners more confidence in your operations.
2. It future-proofs your business
The Cybersecurity Act of 2019 sets a foundation for what’s coming next. The EU is already moving toward mandatory certification in certain high-risk categories through new proposals like the Cyber Resilience Act. Voluntary certification today could soon become a legal requirement.
- Early adoption gives you time to prepare.
- You reduce the risk of fines, business disruption, or regulatory hurdles in the future.
- You stay ahead of competitors who are slower to adapt.
3. It reduces cybersecurity risk
Cyber threats are inevitable. Implementing the CSA certification framework helps minimize vulnerabilities across your product or service lifecycle.
- It promotes security-by-design, embedding safety from the ground up.
- It enhances your internal cybersecurity posture, reducing the likelihood of successful attacks.
- Regular audits and assessments improve accountability and incident response.
4. It strengthens market access across the EU
With over 27 member states, the European Union can be complex for companies navigating multiple national cyber security regulations. The Act simplifies this by creating a single EU-wide standard.
- Certification under the Act ensures you meet compliance across all EU countries.
- It eliminates the need to adjust to different national-level security frameworks.
- That’s more efficiency and lower compliance costs.
5. It signals operational maturity
Nowadays, stakeholders including investors care deeply about digital risk management. Compliance with recognized cybersecurity regulations is seen as a sign of maturity and responsibility.
- It can improve your brand’s public perception.
- It makes due diligence processes smoother during partnerships, mergers, or funding rounds.
- It helps establish your organization as a security-conscious leader in your space.
Who needs to comply with the Cybersecurity Act of 2019?
One of the most frequently asked questions about this cybersecurity act is: “Does it apply to my organization?” The short answer? If your business deals in digital products, services, or infrastructure that operates in or targets the European Union, yes, it matters to you.
The Cybersecurity Act of 2019 primarily affects organizations involved in:
- ICT products and services: This includes software vendors, hardware manufacturers, cloud service providers, and developers of digital platforms and connected devices.
- Critical infrastructure: Operators of essential services such as energy, healthcare, finance, water supply, and transport.
- Government contractors or vendors: Any private sector company that works with EU government agencies or public-sector institutions.
- Managed service providers (MSPs): Especially those offering cybersecurity solutions or support across EU borders.
If your company sells a smart thermostat, cloud-based app, industrial sensor, or even digital authentication software used in the EU, then you’re in the compliance zone.
Currently, certification under the Act’s framework is voluntary. However, this is expected to change soon for high-risk digital products and services. The European Commission has made it clear that:
- Certification could become mandatory for certain ICT categories under future regulations.
- Products that pose high cybersecurity risks (like critical IoT devices or cloud services used in sensitive environments) will likely be the first in line.
Early adopters who certify now won’t just be ahead but they’ll be ready.
Organizations that should take the Cybersecurity Act of 2019 seriously
- Tech startups launching apps or smart devices in EU markets
- Large software vendors with SaaS platforms used by EU clients
- Cloud providers offering storage or computing services in Europe
- IoT manufacturers selling connected home or industrial devices
- Healthcare or fintech firms handling sensitive user data
- Government IT vendors working with EU institutions
Even if your headquarters are outside the EU, say in the US or India, you still need to comply if your digital product or service is used within the EU.
Cybersecurity Act 2019 vs. other security frameworks
The Cybersecurity Act of 2019 is a major milestone in European cybersecurity policy, but how is it different from the other well-known frameworks and regulations? Let’s compare it with some of the most recognized standards around the world, including HIPAA, ISO, NIST, SOC, and CIS.
Cybersecurity Act 2019 vs. HIPAA
| Aspect | Cybersecurity Act 2019 | HIPAA |
| Focus | EU-wide cybersecurity certification for ICT products/services | Protection of health data (PHI) in the U.S. |
| Scope | Broad—covers any digital product or service entering the EU market | Narrow—limited to healthcare providers, insurers, and associates |
| Mandatory? | Voluntary (currently) | Mandatory for covered entities |
| Geographic Reach | European Union | United States |
| Certification | Structured, tiered cybersecurity certification levels | No formal certification, but compliance is enforced via audits |
Bottom line: HIPAA focuses on data privacy in healthcare, while the Cybersecurity Act 2019 takes a more product and infrastructure focused approach, aiming for certification and trust in the digital supply chain.
Cybersecurity Act 2019 vs. ISO (ISO/IEC 27001)
| Aspect | Cybersecurity Act 2019 | ISO/IEC 27001 |
| Focus | Certification of ICT products/services | Information Security Management Systems (ISMS) |
| Scope | Product- and service-specific | Organization-wide systems and processes |
| Certification Type | EU certification levels (Basic, Substantial, High) | ISO-accredited certification for ISMS |
| Implementation | Frameworks developed by ENISA & EU bodies | International standard, applicable globally |
Bottom line: ISO 27001 is about managing organizational risk and creating a secure culture, while the EU cybersecurity act offers product-level certification and helps companies demonstrate trustworthiness in digital markets.
Cybersecurity Act 2019 vs. NIST framework
| Aspect | Cybersecurity Act 2019 | NIST Cybersecurity Framework |
| Focus | EU product/service certification | Organizational risk management |
| Geography | EU | U.S., but adopted globally |
| Voluntary? | Yes (for now) | Yes |
| Implementation | Certification schemes by ENISA | 5-step risk management model (Identify, Protect, Detect, Respond, Recover) |
Bottom line: NIST is a widely used strategy framework, while the Cybersecurity Act brings compliance-based certifications into play. The two can complement each other for businesses operating internationally.
Cybersecurity Act 2019 vs. SOC (SOC 2)
| Aspect | Cybersecurity Act 2019 | SOC 2 |
| Focus | ICT security certification in the EU | Internal controls over data security and privacy |
| Assessor | Accredited EU certifiers | Independent auditors (CPA firms) |
| Report Format | Certification labels (Basic, Substantial, High) | Audit report against Trust Services Criteria |
| Audience | End-users, regulators, business buyers | Clients, partners, regulators in North America |
Bottom line: SOC 2 is ideal for service providers handling sensitive customer data, while the Cybersecurity Act helps certify product-level trust in the EU.
Cybersecurity Act 2019 vs. CIS Controls
| Aspect | Cybersecurity Act 2019 | CIS Controls |
| Focus | EU-wide certification | Actionable, prioritized cybersecurity controls |
| Nature | Regulatory framework | Operational security guide |
| Usage | Proves cybersecurity level to buyers and authorities | Guides implementation of security best practices |
| Certification | Yes | No formal certification, just guidelines |
Bottom line: CIS is more tactical and day-to-day focused, whereas the cybersecurity act 2019 provides a macro-level trust framework that formalizes a company’s cybersecurity strength.
While these frameworks may differ in scope, geography, and enforcement, many of them share the same goal: to improve cyber resilience and reduce risk. In fact, the Cybersecurity Act of 2019 often overlaps with these frameworks in practice. That means businesses already complying with ISO, NIST, or SOC 2 can often leverage existing efforts toward certification under the EU Act.
The Cybersecurity Act of 2019: Compliance today, confidence tomorrow
As cyber threats continue to evolve, so must our response. The Cybersecurity Act of 2019 is a bold and necessary step by the European Union to strengthen its digital defenses and foster trust in an increasingly connected world.
Rather than being a burdensome regulation, this cybersecurity act offers businesses a structured, flexible, and forward thinking path to cybersecurity assurance. Through voluntary certifications, clear frameworks, and consistent standards, organizations can demonstrate their commitment to security.
Aligning with this EU cybersecurity act can help you:
- Enhance your market credibility
- Improve your security posture
- Future-proof your business for upcoming cybersecurity regulations
- Expand into the EU market with greater ease
Start implementing today and turn compliance into a competitive edge.
