Belgium continues to strengthen its national cybersecurity framework through a combination of strategic policy initiatives and a rapidly evolving body of legislation. The country’s overarching policy blueprint is the National Cybersecurity Strategy 2.0 (2021–2025), led by the Centre for Cybersecurity Belgium (CCB). This strategy aims to position Belgium among the least cyber-vulnerable countries in Europe by:
The CCB plays a central role in co-ordinating implementation, supported by sectoral authorities and the National Crisis Center (NCCN). An updated cybersecurity strategy for the period 2025–2030 has been announced but not yet published. The National Cybersecurity Strategy 3.0 is expected to build on the foundations of the previous Strategy, with an emphasis on improving national detection capabilities in order to strengthen overall resilience.
Belgium’s legislative landscape has undergone significant development as part of this broader policy effort. The most consequential reform is the transposition of the EU NIS 2 Directive through the Belgian Act of 26 April 2024, which entered into force on 18 October 2024. This law considerably broadens the scope of cybersecurity regulation in Belgium by classifying organisations as “essential” or “important” entities based on the nature of their services and their size, and by imposing detailed cybersecurity risk management, governance, supply chain oversight and incident notification requirements. Registration of in-scope entities through the CCB’s Safeonweb@Work portal became mandatory as of 18 October 2024.
Parallel regulatory developments apply to the financial sector. The EU Digital Operational Resilience Act (DORA), effective since January 2025, establishes a harmonised framework for ICT risk management, major incident reporting, operational resilience testing and the oversight of Critical Third Party ICT Service Providers. In Belgium, supervision is exercised by the National Bank of Belgium (NBB) and the Financial Services and Markets Authority (FSMA). While many financial institutions also fall within the scope of NIS 2, DORA operates as a lex specialis for the sector. Incident reporting under DORA is made directly to the NBB or FSMA, which then ensures co-ordination with the CCB as needed.
Another important component of the EU cybersecurity framework with direct relevance for companies doing business in Belgium is the Cyber Resilience Act (CRA) (Regulation (EU) 2024/2847). This horizontal regulation applies to products with digital elements (eg, connected devices) placed on the EU market. It introduces secure by design obligations, detailed requirements for vulnerability management and incident reporting, and market surveillance mechanisms. While the CRA entered into force in December 2024, its substantive obligations will become fully applicable in December 2027, with certain intermediary obligations taking effect in September 2026, such as reporting actively exploited vulnerabilities.
Belgium also continues to develop its national cybersecurity certification framework under the EU Cybersecurity Act. The CCB, acting as Belgium’s National Cybersecurity Certification Authority, has created the CyberFundamentals (CyFun®) Framework, which offers a structured set of controls aligned with widely recognised international standards. The framework provides a presumption of conformity for NIS 2 purposes when verified or certified by an authorised Conformity Assessment Body. Therefore, achieving CyFun® certification/verification (or ISO 27001, if aligned with CyFun®) means an entity is presumed to have implemented the necessary, proportionate and adequate cybersecurity measures required by the NIS 2 Directive in Belgium. A new version of the framework, CyFun® 2025, introduces enhanced governance provisions, clearer control formulations and an expanded focus on supply chain and operational technology security.
In addition to these horizontal regimes, sector-specific rules continue to play an important role. For example:
Taken together, these developments reflect Belgium’s shift toward a more comprehensive, integrated and assurance-driven cybersecurity regulatory environment. The Belgian legislature now frames cybersecurity as a matter of both national security and economic continuity, embedding obligations directly at the organisational, sectoral and product levels. The combined effect is a regulatory model that prioritises robust governance, verifiable risk management practices, transparent incident reporting and greater accountability across supply chains. For companies operating in Belgium, understanding the interplay between NIS 2, DORA, the CRA, the GDPR and sector-specific regimes has therefore become an essential element of compliance planning and a core component of overall cyber resilience strategy.
Principal Cybersecurity Statutes and Regulations in Belgium
Belgium’s cybersecurity regulatory landscape consists of a layered system built from constitutional guarantees, EU level regulations and national implementing legislation. The key instruments governing cybersecurity and cyber risk management are as follows.
Belgian Constitution – Article 22
GDPR (Regulation (EU) 2016/679)
Belgian data protection framework
Belgian Criminal Code and Criminal Procedure Code
NIS 2 Act – Belgian Act of 26 April 2024
DORA (Regulation (EU) 2022/2554)
Cyber Resilience Act (CRA – Regulation (EU) 2024/2847)
Cybersecurity Act (Regulation (EU) 2019/881)
Critical Entities Regulation (CER Directive – EU 2022/2557) and Belgian Critical Infrastructures Act (2011, amended 2023)
AI Act (Regulation (EU) 2024/1689)
Interplay Between NIS 2, DORA, the CRA and Other Instruments
Belgium’s cybersecurity framework is now characterised by vertical (sector-specific) and horizontal (cross-sectoral) EU legislation. Their relationship can be summarised as follows.
NIS 2 as the horizontal baseline
NIS 2 is the overarching EU cybersecurity instrument, which:
In Belgium, the NIS 2 Act ensures integration with national crisis management structures and sectoral regulators co-ordinated by the CCB.
DORA as a sector-specific lex specialis for the financial sector
CRA as a product security regime complementing NIS 2
Cybersecurity Act and certification as a connecting layer
AI Act interactions
Belgium’s cybersecurity enforcement framework is built around several federal authorities with complementary mandates. These bodies supervise compliance with key cybersecurity laws, including the NIS 2 Act, the Cybersecurity Act, DORA, the Critical Infrastructures Act and sector-specific security requirements. Their roles, powers and operational capabilities, including incident response functions, are summarised below.
Centre for Cybersecurity Belgium (CCB)
Mandate
The CCB is Belgium’s central cybersecurity authority, reporting to the Federal Prime Minister. It designs, co-ordinates and oversees national cybersecurity strategy, and leads implementation of the NIS 2 Act. It also serves as Belgium’s national point of contact for EU cybersecurity bodies.
Supervisory and enforcement powers
Investigative tools
Incident response role
The CCB hosts Belgium’s national Computer Emergency Response Team (CERT.be), providing 24/7 monitoring, triage and incident co-ordination. CERT.be collaborates with sectoral Computer Security Incident Response Teams (CSIRTs) and EU-level networks.
Sectoral Competent Authorities Under the NIS 2 Act
Sector-specific authorities work alongside the CCB to supervise cybersecurity obligations within their respective domains. They hold regulatory, investigative and enforcement powers tailored to sector risks.
Energy sector: Federal Public Service Economy
Mandate
Powers
Incident response
Transport sector
Powers
Incident response
Health sector – Federal Public Service Public Health
Mandate
Powers
Incident response
Digital infrastructure and digital services – BIPT
Mandate
Powers
Incident response
National Crisis Center (NCCN)
Mandate
Powers
Incident response
While not a CSIRT, the NCCN works closely with the CCB and CERT.be during major cyber incidents affecting public safety or national security.
Belgian Data Protection Authority (DPA)
Mandate
Powers
Incident response
Coordination Unit for Threat Analysis (CUTA)
Mandate
Powers
National Security Council (NSC)
Mandate
Belgium has implemented the NIS 2 Directive through the NIS 2 Act of 26 April 2024, which significantly expands the types of public and private entities subject to cybersecurity oversight.
The NIS 2 Act applies to the following organisations established in Belgium that provide services listed in Annex I (essential sectors) or Annex II (important sectors) within the EU:
Whether an entity falls within scope depends on the nature of the activity and whether it meets the applicable size criteria under Commission Recommendation 2003/361/EC, unless the Annex introduces a different size-based test.
Belgium’s approach is intentionally broad. The CCB has clarified that the NIS 2 Act applies to the entirety of an in-scope organisation, not only the business unit performing the regulated service. Even where the regulated activity is ancillary, the NIS 2 Act may still apply unless the Annex expressly limits scope based on principal or ancillary activities.
From a territorial standpoint, “establishment” requires stable and continuous operations in Belgium, including subsidiaries, branches or permanent installations. Operators designated as critical infrastructure under the Belgian Critical Infrastructures Act are automatically deemed essential entities under the NIS 2 Act.
While the NIS 2 Act reduces many uncertainties that existed under the former NIS 1 regime, organisations must still engage in careful mapping of their services, supply chains and group structures to determine coverage. Despite extensive guidance from the CCB, the most persistent uncertainties and challenges concern:
Entities subject to the NIS 2 Act must implement a comprehensive, risk-based cybersecurity programme that aligns with the heightened obligations introduced under the NIS 2 Directive. Belgian law requires in-scope organisations to:
The CCB’s CyFun® Framework remains the primary national reference point for demonstrating compliance. Entities that obtain CyFun® or ISO/IEC 27001 certification benefit from a presumption of conformity with NIS 2 security requirements.
Incident Classification and Thresholds
Under the Belgian NIS 2 Act, incident reporting obligations apply only to significant incidents – ie, those that have a substantial impact on the continuity or security of Annex I/II services and that:
Mandatory Multi-Stage Notification Timeline
The Belgian NIS 2 Act adopts a three-phase reporting model that mirrors the requirements of the NIS 2 Directive. Reporting deadlines run from the moment the entity becomes aware of the significant incident.
Early warning – within 24 hours
Entities must notify the CCB:
The early warning aims to provide preliminary situational awareness to the CCB. It may include suspected causes, early indicators of compromise, initial containment measures and any cross-border implications. The CCB recognises that information at this stage is preliminary, and encourages early notification even when investigative findings remain incomplete.
Incident notification – within 72 hours
A more detailed incident notification must be submitted:
The notification should include updated technical details, the systems and services affected, the assessed or likely impact, known or suspected attack vectors, indicators of compromise, and measures taken or planned to contain the incident.
For entities in the financial sector subject to DORA, notifications must be submitted to the NBB or the FSMA; these authorities then transmit the notification to the CCB.
Final report – within one month
A comprehensive final report must be submitted within one month after the detailed notification.
The report must include a root cause analysis, a complete timeline from detection through recovery, a detailed impact and remediation analysis, and long-term mitigation measures. The CCB or relevant sectoral authority may request additional interim updates.
Notification Channels and Competent Authorities
All notifications must be submitted through the CCB’s secure online reporting platform, accessible via Safeonweb@Work. The CCB functions as Belgium’s:
The CCB shares information with relevant sectoral authorities and, for essential entities, with the NCCN, which co-ordinates national level crisis management.
Sector-specific oversight bodies include:
Required Content of Notifications
Regulators expect the following elements, tailored to the maturity of the investigation.
Early warning (24 hours)
Incident notification (72 hours)
Final report (one month)
The CCB has released a “NIS 2 Quickstart Guide” and provides a library of template policies (eg, for risk management and incident handling) to help organisations standardise their internal procedures. The CCB is also expected to issue unified templates to standardise reporting across sectors.
Treatment of Early Warnings
The CCB treats early warnings as situational awareness tools, not enforcement triggers. It recognises that information may be incomplete or subject to change, and typically does not penalise entities for corrections or updates. Instead, the CCB encourages swift reporting to prevent potential incident escalation.
Obligation to Inform Recipients and the Public
If an incident is likely to adversely affect service recipients, the entity must:
In cases of broader public risk, the CCB may require public disclosure.
Multi-Agency and Parallel Reporting Obligations
Depending on the nature of the incident, additional reporting requirements may apply, as follows.
The CCB is responsible for overseeing all aspects of NIS 2 implementation in Belgium, including:
The CCB represents Belgium in the NIS Cooperation Group, the CSIRT Network and the European Cyber Crisis Liaison Organisation Network (EU CyCLONe).
The NCCN supports the CCB in national cyber crisis management, risk preparedness and handling incidents with cross-sector or national level impact.
Sectoral regulators continue to enforce sector-specific obligations, with enhanced collaboration mechanisms introduced under NIS 2 to ensure coherent national supervision and co-ordinated incident response.
Belgium applies DORA as the primary regulatory framework governing the operational resilience of financial entities. DORA has applied since 17 January 2025 and covers a broad range of regulated financial entities established in Belgium or operating through Belgian or other EU branches, including:
DORA also applies indirectly to third-party ICT service providers that supply ICT services to financial entities. An ICT provider that is designated as “critical” by the European Supervisory Authorities becomes subject to direct EU level oversight and must establish an EU legal presence, even if headquartered outside the European Union. In this way, DORA has a limited but significant extraterritorial impact on non-EU critical ICT service providers that support the EU financial sector.
The NBB and the FSMA serve as the competent authorities responsible for supervising DORA implementation by financial entities. Where DORA applies as a sector-specific lex specialis, its requirements prevail over horizontal obligations under the NIS 2 Act.
DORA imposes detailed contractual, governance and oversight obligations on financial entities engaging third-party ICT service providers. “ICT service providers” are broadly defined to include providers of cloud computing, data centres, hosting and storage, cybersecurity services, network services, managed IT services, software, data analytics, back-up and recovery solutions, and related support and maintenance.
Financial entities within scope of DORA must maintain a comprehensive Register of Information (RoI) covering all third-party ICT arrangements. Contracts supporting “critical or important functions” must meet specific minimum standards, including:
Belgian supervisory practice reflects the EU level regulatory technical standards (RTS/ITS), including those on contractual requirements, subcontracting, classification of incidents, and RoI harmonisation.
Financial entities must implement a management body-owned ICT risk management framework addressing identification, protection, detection, response and recovery.
Financial entities must classify ICT-related incidents using EU harmonised materiality thresholds. If they determine that an ICT incident is “major” based on factors like impact on clients, transactions, data and duration, they must report the major incident within the following strict timelines.
Financial entities must also notify clients where major incidents materially affect the financial interests or the continuity of services provided to them. DORA introduces a voluntary notification mechanism for “significant cyber threats”, enabling authorities to share threat information horizontally across the sector.
For financial entities in Belgium that are subject to DORA, incident reports are submitted to the NBB or FSMA, as applicable. These authorities subsequently transmit the reports to the CCB, ensuring alignment with the Belgian NIS 2 notification framework.
The NBB and FSMA supervise compliance by financial entities with DORA’s ICT risk management and third-party oversight requirements. National supervisory measures may include remedial actions, heightened supervision and administrative fines for breaches of DORA obligations.
In parallel, the European Supervisory Authorities (EBA, EIOPA and ESMA) designate certain ICT service providers as Critical ICT Third Party Providers (CTPPs). For each designated CTPP, one of the ESAs acts as the Lead Overseer. The Lead Overseer’s enforcement and oversight tools include requesting information, conducting investigations and on-site inspections, issuing recommendations, performing ongoing oversight activities, and imposing periodic penalty payments to ensure the CTPP’s compliance with DORA’s operational resilience requirements.
DORA does not impose general EU data localisation requirements; however, it requires transparency and risk mitigation for all locations in which data is processed or stored. Where ICT services involve personal data, the GDPR’s rules on international data transfers (Chapter V) apply, including obligations to ensure that the transferred data remains protected via adequacy decisions, Standard Contractual Clauses or Binding Corporate Rules, and that Transfer Impact Assessments are performed, where required.
Financial entities should integrate GDPR transfer risk assessments into their DORA third-party risk management processes. Contractual arrangements should specify data processing locations and set out notification and approval mechanisms for the relocation of data or services to third countries.
Under Articles 26–27 of DORA, certain “significant” financial entities must conduct threat-led penetration testing (TLPT) every three years. The EU TLPT Regulatory Technical Standards, effective July 2025, align with the EU’s Threat Intelligence Based Ethical Red Teaming (TIBER EU) framework, which Belgium implements through the NBB’s TIBER BE programme.
TIBER BE co-ordinates intelligence-led red team testing of entities’ critical or important functions using realistic cyber-attack scenarios. Co-operation from ICT service providers may be required where they are identified as CTPPs for the systems in scope.
TLPT exercises performed in accordance with TIBER EU’s mandatory requirements may be recognised across borders by competent TLPT authorities.
Financial entities in Belgium likely to be designated as “significant” should prepare by:
Belgium’s cyber-resilience framework is defined largely by directly applicable EU legislation – most notably the Cyber Resilience Act (CRA), which entered into force on 10 December 2024. As a horizontal regulatory framework, the CRA establishes mandatory cybersecurity requirements for PDEs placed on the EU/Belgian market. The CRA applies irrespective of where the manufacturer of the PDE is located; non-EU entities placing PDEs on the Belgian market are fully in scope.
The CRA requires cybersecurity to be embedded throughout the entire life cycle of a PDE, from initial design and development to post-market monitoring and end of support activities.
The CRA complements, rather than replaces, sector-specific Belgian and EU regimes, such as the NIS 2 Act, the Cybersecurity Act and sectoral instruments governing telecoms, medical devices and financial services.
Its scope is intentionally broad. PDEs include nearly any software or hardware product – such as consumer and industrial IoT devices, embedded systems, connected hardware, enterprise and standalone software – whose intended or foreseeable use involves a direct or indirect data connection to a device or network. Pure SaaS and cloud services are generally excluded unless the service forms part of a PDE or is required for a PDE’s functioning. Cloud service providers may still fall under other regulatory frameworks such as NIS 2, and under DORA when providing ICT services to in-scope financial entities.
The CCB will play a central role in co-ordination, market surveillance and enforcement support, working alongside the Federal Public Service Economy and relevant EU bodies. It is expected to materially strengthen Belgium’s security posture by reducing systemic vulnerabilities in the digital products that underpin commercial operations and public services.
The CRA imposes a set of cybersecurity obligations on manufacturers, importers and distributors of PDEs placed on the EU/Belgian market, and (in limited cases) open source software stewards. These obligations focus on embedding cybersecurity into the design, development, distribution and maintenance of all PDEs placed on the Belgian market.
Security by Design and Security by Default Requirements
PDE manufacturers must ensure that cybersecurity is built into PDEs from the earliest stages of product conception. Key requirements include:
Manufacturers must also implement processes for continuous improvement and adhere to “state of the art” security expectations throughout the product’s life cycle.
Vulnerability Handling, Patching and Update Timelines
The CRA introduces harmonised EU rules for vulnerability management. Manufacturers of PDEs must:
As of 11 September 2026, manufacturers will also be required to report actively exploited vulnerabilities and severe cybersecurity incidents through the EU’s new single reporting platform. This includes:
Post-Market Surveillance Obligations
Manufacturers of PDEs are required under the CRA to conduct post-market monitoring and ensure continued cybersecurity throughout the product’s support period. This includes:
Importers and distributors operating in Belgium must ensure that any PDE they place on the EU market:
Conformity Assessment and CE Marking
All PDEs must undergo a conformity assessment to demonstrate compliance with the CRA’s essential cybersecurity requirements. Public EU guidance makes clear that:
These conformity assessment obligations become mandatory from 11 December 2027, when the CRA enters into full application.
Transparency and Information Requirements
Manufacturers of PDEs must provide users with clear and accessible information, including:
These disclosures aim to support more informed procurement decisions by Belgian businesses and public entities.
Product Recall, Withdrawal and Corrective Measures
When cybersecurity risks cannot be mitigated through patches or updates, authorities may require PDE manufacturers, importers or distributors to:
Market surveillance authorities may also require insecure product functionality to be disabled where necessary.
Enforcement and Penalty Structures
The CRA establishes a unified EU-wide enforcement and market surveillance framework aimed at ensuring consistent oversight of cybersecurity requirements for PDEs across all EU member states. Enforcement operates under the EU’s horizontal market surveillance architecture (Regulation (EU) 2019/1020), with each EU member state designating its own competent authorities.
In Belgium, CRA supervision is carried out by the CCB and the Federal Public Service Economy, which together perform the roles of market surveillance authority and enforcement body within the national context.
Competent authorities – whether Belgian or EU level – are empowered to undertake a broad range of supervisory actions, including:
In addition, the CRA introduces a harmonised penalty framework, setting the following maximum administrative fines:
Belgium adopts a multi-layered approach to cybersecurity certification that combines national, EU-wide and sector-specific frameworks. Together, these create both voluntary and mandatory obligations depending on the product, service or sector concerned, and increasingly influence procurement, supply chain assurance and market access for companies operating in Belgium.
National Framework: CyberFundamentals (CyFun®)
Belgium’s flagship national scheme is CyFun®, managed by the CCB, which also serves as the National Cybersecurity Certification Authority. CyFun® is designed to raise cybersecurity maturity across Belgian organisations and support compliance with the Belgian NIS 2 Act. CyFun® offers four levels:
Basic and Important require independent verification, whereas Essential requires full certification by an accredited and CCB-authorised Conformity Assessment Body (CAB). CyFun® is not legally mandatory but is widely used because it provides for the presumption of conformity with NIS 2 requirements.
EU Level Schemes Under the Cybersecurity Act
At the EU level, certification follows the Cybersecurity Act (Regulation (EU) 2019/881), which establishes an EU‑wide framework for harmonised cybersecurity certification schemes.
The first adopted scheme is the EUCC, formalised by Implementing Regulation (EU) 2024/482. The EUCC is based on the Common Criteria (ISO/IEC 15408) and the Common Evaluation Methodology (ISO/IEC 18045). It provides two assurance levels: Substantial and High, applicable to a wide range of ICT products, including software, hardware and security components. EUCC certification is voluntary under the Cybersecurity Act, but may become mandatory where required by EU sectoral legislation or EU member state law, and procurement rules may also impose it.
Two additional schemes, still under development, will have significant future impact.
The proposed 2026 revision of the Cybersecurity Act aims to streamline certification, strengthen supply chain protections, and enhance the role of the EU Agency for Cybersecurity (ENISA), likely making certification increasingly relevant for access to public sector markets.
Mandatory Sector-Specific Schemes
Some certification regimes are not voluntary and directly determine market access.
Interactions With Belgian Practice
Organisations operating in Belgium typically use a combination of CyFun® (organisational maturity), EUCC (product assurance), RED compliance (IoT devices) and sectoral schemes, such as UNECE R155. NIS 2-regulated entities increasingly require suppliers to demonstrate certification, making these schemes important not only for regulatory compliance but also for staying competitive in procurement.
Belgium’s cybersecurity and personal data breach notification obligations derive primarily from the GDPR and the Belgian Data Protection Act of 30 July 2018, which supplements the GDPR at national level. The DPA is the competent supervisory authority. The combined framework imposes robust expectations on organisations regarding technical and organisational security measures, risk management, vendor oversight and timely incident reporting.
This section outlines the core cybersecurity requirements applicable when processing personal data in Belgium and provides an overview of the thresholds, timelines and content obligations for breach notifications.
Security Requirements for Processing Personal Data
General obligations
Controllers and processors must implement appropriate technical and organisational measures to ensure a level of security appropriate to the risk associated with the processing of personal data. This requirement obliges organisations to consider:
Typical measures expected in Belgium
While Belgian law remains technology-neutral, the DPA generally expects measures such as:
Where appropriate, Belgium also expects regular testing and evaluation of security measures (eg, penetration tests, audits, tabletop exercises).
Definition and Assessment of a Personal Data Breach
Belgium applies the GDPR definition of a personal data breach, under which a personal data breach is “a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorised disclosure of, or access to, personal data”. The Belgian DPA emphasises that not every security incident amounts to a breach; however, controllers must conduct a prompt and documented assessment of every incident involving personal data.
Notification to the Belgian DPA
Threshold for notification
Controllers must notify the DPA unless the personal data breach is unlikely to result in a risk to the rights and freedoms of individuals. Risk indicators include:
Deadline
The DPA launched a new, centralised online portal for data breach notifications in June 2025 that introduces a structured, mandatory two-stage notification process.
Required content
The notification to the DPA must include at least the following:
Belgium’s AI-specific cybersecurity obligations are now primarily driven by the directly applicable EU Artificial Intelligence Act (AI Act), which imposes security by design and security by default requirements throughout the life cycle of AI systems.
Under the AI Act, high-risk AI systems must be technically resilient, protected against data poisoning, model evasion and other adversarial attacks, and supported by secure logging, monitoring and post market surveillance mechanisms. Providers and deployers of high-risk AI systems must also address supply chain and model component risks, ensuring that upstream general purpose or foundational models are subject to appropriate due diligence, vulnerability testing and mitigation measures.
The AI Act’s incident reporting framework requires notification of “serious incidents”, including systemic cybersecurity failures, while any personal data breach triggered by an AI security incident must also be notified under Belgium’s GDPR regime.
For entities already subject to NIS 2, the AI Act operates alongside Belgium’s 24-hour early warning and 72-hour incident notification rules, creating a layered reporting landscape. Belgian regulators have emphasised that AI-related obligations do not displace existing cybersecurity or data protection duties; instead, the AI Act complements the GDPR’s security requirements by imposing additional model-specific safeguards and enhanced accountability for organisations developing or deploying AI systems.
Cybersecurity requirements in Belgium’s healthcare sector stem from a combination of EU-level product regulations, horizontal cybersecurity legislation and sector-specific supervisory expectations. Healthcare providers, hospitals, medical device manufacturers and operators of electronic health record (EHR) systems must comply not only with the GDPR and NIS 2 Act but also with the security and safety requirements embedded in the EU Medical Devices Regulation (MDR). Belgium’s Federal Agency for Medicines and Health Products (FAMHP) plays a central role in supervising device-related incidents, while the DPA oversees data protection and breach notification obligations.
Healthcare Providers and Hospitals
Hospitals and many other healthcare providers qualify as “essential” or “important” entities under the NIS 2 Act. As a result, they must implement proportionate technical and organisational cybersecurity measures, including:
They must also comply with Belgium’s multi-stage incident reporting framework, which requires an early warning within 24 hours, a 72-hour incident notification, and a final report within one month. These expectations are reinforced by sector-specific guidance and broader national trends toward assurance-based supervision.
Where incidents involve personal data such as patient records, healthcare providers must also comply with notification obligations under the GDPR.
Medical Devices and Software as a Medical Device (SaMD)
The EU Medical Device Regulation (MDR) imposes detailed cybersecurity obligations on manufacturers. Devices incorporating software – including SaMD and connected medical devices – must be “developed and manufactured in accordance with the state of the art”, including robust information security controls. Manufacturers must define minimum IT network characteristics, hardware requirements and security controls, including protections against unauthorised access.
Manufacturers must also operate post-market surveillance systems, monitor emerging vulnerabilities, and implement corrective and preventative measures when security flaws are identified. Cybersecurity weaknesses that could affect patient safety require immediate reporting to the FAMHP through the EU’s vigilance system.
Electronic Health Record Systems
EHR systems process large quantities of sensitive health data and therefore fall within the GDPR’s heightened security framework. Controllers must:
If an EHR provider meets the criteria of an essential or important NIS 2 entity, or acts as a critical third-party ICT provider to a hospital, it must comply with Belgium’s NIS 2 risk management and incident reporting requirements.
Procurement and Certification
Belgium’s shift toward assurance-based cybersecurity also affects procurement. While certification is not mandatory for healthcare providers, the national CyFun® framework is increasingly used to demonstrate compliance and is relevant for suppliers of medical IT systems. Healthcare sector procurement increasingly includes requirements relating to secure development, patch management, supplier assurance and conformity assessment for MDR-regulated devices.
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Introduction
Cybercrime has significantly increased in recent years, with a growing number of ransomware attacks, increasingly sophisticated phishing campaigns, and major data breaches affecting both private companies and public institutions. As a result, cybersecurity has become a key strategic concern in Belgium for both the public and private sectors.
The regulatory landscape in this area remains under construction, with certain legislation already in force and other requirements set to apply in the coming years, as follows.
An analysis of some of these topics and developments follows.
CCB Publishes Second Version of the NIS 2 FAQ
In 2025, the CCB released a second version of its FAQ, clarifying several key aspects of the Belgian NIS 2 implementation act (the “NIS 2 Law”).
The main points clarified by the CCB include the following.
Cybersecurity Measures to Gain a Competitive Edge in the Supply Chain
Cybersecurity is no longer evaluated solely within the boundaries of an organisation’s own systems: it is assessed across the entire value chain. Indeed, supply chains have become one of the most common vectors for cyber incidents, and the NIS 2 Directive requires in-scope entities to implement specific cybersecurity measures to manage their supply chains. As a result, in-scope organisations impose obligations on their suppliers, including those not directly subject to NIS 2, which are now increasingly indirectly impacted by this legislation.
Many suppliers have understood that they can gain a strategic advantage by embedding cybersecurity into their operations. By adopting robust security practices, they strengthen client and partner trust, increase operational resilience, and position themselves as more competitive players in the market. This trust translates into tangible commercial value. Customers are more likely to work with suppliers who can demonstrate effective management of third-party risks, particularly when services are business-critical or involve sensitive data. In competitive tenders, credible cybersecurity governance can serve as a clear differentiator, especially where price or functionality alone would not suffice. What was once a distinguishing feature of the most security-conscious organisations is rapidly becoming a baseline expectation across the market.
CyFun® 2025 as a Major Framework in Belgium
Since the entry into force of the NIS 2 Directive in Belgium, many organisations have adopted the Belgian CyFun® framework.
CyFun® is a structured framework providing:
The key advantage of CyFun® lies in providing a common language for authorities, auditors and organisations, reducing ambiguity about what constitutes satisfactory NIS 2 compliance. It is designed to:
It is important to note that CyFun® certification also grants a legal presumption of compliance with the Belgian NIS 2 Law.
Although developed at a national level in Belgium, CyFun® is designed for recognition and use at a broader EU level. Romania has already officially adopted the framework, and several other EU member states, including France, acknowledge CyFun®’s value and are exploring integration or full adoption.
Transposition of CER Directive into Belgian Law
The law transposing the Critical Entities Resilience Directive into Belgian law is expected in 2026. This represents a significant step toward completing the long-overdue transposition, which was initially required by 17 October 2024. This new legislation will replace the Critical Infrastructures Directive (2008/114/EC) and its 2011 Belgian transposition law.
The sectors covered by the CER Directive are similar to NIS 2, although the list is not identical:
Whereas NIS 2 focuses on the cybersecurity of networks, information systems and data, the CER Directive adopts a broader approach aimed at the overall resilience of critical entities. It addresses all risks (physical, natural, human or cyber) that could disrupt the provision of essential services.
The two laws are thus complementary: NIS 2 governs digital security, while CER ensures the operational continuity and robustness of critical infrastructures. Entities designated as “critical” under CER will generally also be considered “essential” under NIS 2.
For sectors subject to detailed European regulatory regimes (notably banking, financial market infrastructures and digital infrastructures), certain CER provisions may not apply when equivalent sector-specific obligations exist.
Companies’ principal obligations under the CER Directive are as follows.
Entities providing essential services in six or more EU member states are subject to special compliance procedures due to their European significance.
In accordance with the draft CER implementation law, a number of additional provisions will apply in Belgium compared to the general framework set out in the CER Directive.
Conclusion – Key Points to Keep in Mind
Belgium is rapidly advancing its cybersecurity and critical infrastructure regulatory framework, aligning closely with EU directives.
Organisations must recognise that compliance is not optional; it is a strategic necessity affecting internal operations as well as supply chain relationships and market competitiveness.
The CCB’s latest NIS 2 FAQ provides useful clarifications.
The CyFun® framework has emerged as a major tool in Belgium (as well as in certain other EU jurisdictions) for achieving structured, auditable and EU-recognised compliance. Its adoption helps organisations demonstrate adherence to NIS 2 standards while also facilitating cross-border recognition and audit processes.
The CER Directive is expected to be transposed in Belgium in 2026, and requires organisations to prepare for sector-specific obligations, resilience planning, reporting and co-operation with authorities. The introduction of sanctions underscores the importance of proactive compliance.
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