EU Assessments & Compliance

DORA (Digital Operational Resilience Act) is an EU regulation that strengthens the digital operational resilience of financial entities. It applies to credit institutions, investment firms, payment institutions, e-money institutions, crypto-asset service providers, insurance and reinsurance undertakings, and other financial entities operating in the EU. DORA requires entities to manage ICT risks, ensure business continuity, and maintain operational resilience.

The EU AI Act is comprehensive legislation regulating artificial intelligence systems in the EU. It applies to AI providers placing AI systems on the EU market, AI users deploying AI systems in the EU, importers and distributors of AI systems, and organizations developing or using AI systems that affect people in the EU. The Act categorizes AI systems by risk level (unacceptable, high-risk, limited risk, minimal risk) with different requirements for each category.

NIS2 Directive is EU cybersecurity legislation that strengthens cybersecurity requirements for essential and important entities. Essential entities include operators of essential services in sectors like energy, transport, banking, financial market infrastructures, health, drinking water, digital infrastructure, and public administration. Important entities include digital service providers, postal services, waste management, manufacturing, and other sectors. Both categories must implement cybersecurity risk management measures and report incidents.

EU Cloud Code of Conduct is a GDPR Article 40 code of conduct providing voluntary certification framework for cloud service providers. It demonstrates GDPR compliance through independent third-party assessment. Cloud service providers including Infrastructure as a Service (IaaS), Platform as a Service (PaaS), Software as a Service (SaaS), and managed service providers operating in the EU can certify. Certification provides evidence of GDPR compliance to regulators and customers.

Assessment timelines vary based on the framework, entity size, complexity, and current compliance maturity. DORA assessments typically take 3-6 months, EU AI Act conformity assessments 2-4 months, EU Cloud Code of Conduct certification 3-5 months, and NIS2 Directive compliance 2-4 months. Organizations pursuing compliance for the first time may need 6-12 months for gap assessment, remediation, and formal validation depending on the framework and entity complexity.

Penalties vary by framework. DORA violations can result in fines up to €10 million or 5% of annual turnover. EU AI Act violations can result in fines up to €35 million or 7% of global annual turnover for prohibited AI practices, and up to €15 million or 3% for other violations. NIS2 Directive violations can result in fines up to €10 million or 2% of annual turnover. All frameworks may also result in operational restrictions, market access limitations, and reputational damage.

Yes, many organizations combine multiple EU assessments to maximize efficiency and reduce costs. Financial entities often coordinate DORA and NIS2 assessments as they have overlapping cybersecurity requirements. Organizations using AI systems may combine EU AI Act compliance with other frameworks. EU Cloud Code of Conduct certification can complement GDPR compliance. Our team helps coordinate multiple assessments to leverage shared evidence, common controls, and unified governance while ensuring comprehensive compliance.

Required documentation varies by framework but typically includes risk management policies and procedures, incident response plans, business continuity plans, security policies, technical documentation, conformity assessments (for EU AI Act), records of processing activities, data protection impact assessments, vendor management procedures, and evidence of control implementation. We help you identify required documentation and develop missing policies and procedures as part of the assessment process.

EU compliance is an ongoing process. After initial validation, organizations must maintain controls, conduct regular assessments, update documentation as operations change, monitor for incidents, and ensure ongoing compliance with evolving regulations. Most frameworks require annual reassessment or continuous monitoring. DORA requires annual testing and regular reviews. EU AI Act requires ongoing monitoring of AI systems. We provide ongoing support to help you maintain compliance and prepare for reassessment.

Yes, many EU regulations have extraterritorial scope. DORA applies to financial entities operating in the EU regardless of where they are headquartered. EU AI Act applies to AI providers placing AI systems on the EU market, regardless of location. NIS2 Directive applies to entities providing services in the EU. EU Cloud Code of Conduct applies to cloud service providers processing personal data of EU residents. Organizations outside the EU must comply if they meet the scope criteria for these regulations.