DORA
EU regulation for digital operational resilience in financial sector
CE Marking
EU conformity marking for health, safety, and environmental requirements
Quick Verdict
DORA mandates digital resilience for EU financial entities against ICT risks, while CE Marking requires manufacturers to declare product safety compliance for EEA market access. Financial firms adopt DORA for regulatory survival; manufacturers use CE Marking to enable free trade.
DORA
Regulation (EU) 2022/2554, Digital Operational Resilience Act
Key Features
- Mandates comprehensive ICT risk management frameworks
- Enforces 4-hour major incident reporting timelines
- Requires triennial threat-led penetration testing
- Oversees critical third-party ICT providers
- Applies proportionality principle to entity size
CE Marking
CE Marking (Conformité Européenne)
Key Features
- Manufacturer declaration of conformity to EU essential requirements
- Harmonised standards provide presumption of conformity via OJEU
- Risk-based conformity modules A-H with Notified Body option
- Technical file retention for 10+ years post-market
- Enables free product movement across EEA single market
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
DORA Details
What It Is
Digital Operational Resilience Act (DORA), formally Regulation (EU) 2022/2554, is an EU-wide regulation enhancing digital operational resilience in the financial sector against ICT disruptions like cyberattacks and third-party failures. Applicable from January 17, 2025, it targets 20 financial entity types and critical ICT providers (CTPPs) across 27 member states, using a risk-based, proportional approach.
Key Components
- **ICT Risk ManagementFrameworks for risk identification, mitigation, controls, and annual reviews overseen by management.
- **Incident ReportingLog, classify, report major incidents within 4 hours, 72-hour updates, 1-month analysis.
- **Resilience TestingAnnual basic tests; triennial threat-led penetration testing (TLPT) for critical entities.
- **Third-Party OversightDue diligence, standardized contracts, ESAs supervision of CTPPs. Compliance via RTS/ITS, no certification.
Why Organizations Use It
Mandated to avoid fines up to 2% global turnover, mitigate risks (74% ransomware hit), ensure systemic stability, build trust. Drives cybersecurity investments, harmonizes practices.
Implementation Overview
Gap analyses, framework/policy development, testing programs, vendor management. Applies to ~22,000 EU entities; proportional by size/risk. Ongoing monitoring, audits per Batch 1/2 standards.
CE Marking Details
What It Is
CE Marking (Conformité Européenne) is the EU's mandatory conformity marking for products under harmonised legislation. It serves as the manufacturer's declaration that products meet essential health, safety, environmental, and consumer protection requirements. The approach is risk-based, using New Legislative Framework (NLF) modules for conformity assessment.
Key Components
- Identifies applicable directives (e.g., LVD 2014/35/EU, Machinery Directive).
- Harmonised standards from OJEU for presumption of conformity.
- Conformity modules A-H (self-assessment or Notified Body).
- Technical documentation, EU Declaration of Conformity (DoC), and CE affixation. Self-declaration common for low-risk; third-party for high-risk.
Why Organizations Use It
Mandated for EEA market access; enables free movement. Reduces trade barriers, manages liability, builds trust. Strategic for tenders, competition; supports sustainability.
Implementation Overview
Map legislation, assess risks, test via standards/Notified Bodies, compile technical file/DoC, affix mark. Applies to manufacturers/importers in EEA-impacted industries. No central certification; audit-ready files for surveillance. Typical for mid-large orgs; 6-12 months.
Key Differences
| Aspect | DORA | CE Marking |
|---|---|---|
| Scope | Digital operational resilience in finance | Product health, safety, environmental compliance |
| Industry | EU financial entities and ICT providers | Manufacturers across multiple product sectors |
| Nature | Mandatory EU regulation with ESAs enforcement | Manufacturer self-declaration under harmonised laws |
| Testing | Annual basic, triennial TLPT by independents | Conformity modules, risk-based notified body optional |
| Penalties | Up to 2% global turnover fines | Product withdrawal, fines by national authorities |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about DORA and CE Marking
DORA FAQ
CE Marking FAQ
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