NIS2
EU regulation enhancing cybersecurity resilience in critical sectors
CE Marking
EU marking for product safety and market access compliance
Quick Verdict
NIS2 mandates cybersecurity resilience for EU critical entities via risk management and reporting, while CE Marking requires manufacturers to declare product safety conformity through assessments. Companies adopt NIS2 for regulatory compliance and cyber defense; CE Marking for EEA market access.
NIS2
Network and Information Systems Directive 2 (NIS2)
Key Features
- Broadens scope via size-cap rule to medium/large entities
- Mandates strict 24/72-hour incident reporting timelines
- Enforces direct senior management accountability
- Requires continuous risk management and supply chain security
- Imposes fines up to 2% global annual turnover
CE Marking
CE Marking (Conformité Européenne)
Key Features
- Manufacturer self-declaration of conformity to EU rules
- Harmonised standards provide presumption of conformity
- Risk-based conformity assessment modules A-H
- Technical file retention for 10+ years
- Notified Body involvement for high-risk products
Detailed Analysis
A comprehensive look at the specific requirements, scope, and impact of each standard.
NIS2 Details
What It Is
The NIS2 Directive (Directive (EU) 2022/2555) is an EU regulation expanding the original NIS Directive to achieve a high common cybersecurity level across member states. It targets essential and important entities in broadened sectors like energy, transport, health, and digital infrastructure. NIS2 adopts a risk-based approach emphasizing continuous assurance over static compliance.
Key Components
- **Risk managementOngoing assessments, supply chain security, access controls, encryption.
- **Incident reporting24-hour early warning, 72-hour notification, one-month final report.
- **Business continuityResilience plans, recovery procedures.
- **Corporate accountabilityDirect responsibility for senior management. Compliance relies on national authorities' supervision, spot checks, and no formal certification but mandatory registration.
Why Organizations Use It
- Legal obligation for covered entities to avoid fines up to 2% global turnover.
- Bolsters resilience against cyber threats, ensures service continuity.
- Enhances trust, aligns with ISO 27001/NIST, supports multi-country operations.
Implementation Overview
- Conduct gap analysis, deploy measures, setup reporting to CSIRTs.
- Targets medium/large entities (50+ employees, €10M+ turnover) in EU sectors.
- Member states transpose by October 2024; involves training, audits, cross-border coordination.
CE Marking Details
What It Is
CE Marking (Conformité Européenne) is the EU's mandatory compliance marking for products under harmonised legislation. It serves as the manufacturer's declaration that products meet essential health, safety, and environmental requirements, enabling free movement across the EEA. The approach is risk-based, scaling conformity assessment from self-declaration to third-party verification via Notified Bodies.
Key Components
- Identification of applicable directives (e.g., LVD, Machinery, RED).
- Essential requirements met via harmonised standards (OJEU-published for presumption of conformity).
- Conformity modules A-H; technical documentation; EU Declaration of Conformity (DoC).
- Self-assessment for low-risk; Notified Body for high-risk; no central certification.
Why Organizations Use It
- Legal market access to €5T EEA market.
- Risk mitigation against fines, recalls, liability.
- Builds trust, procurement preference, supply chain efficiency.
- Strategic enabler for innovation under standards.
Implementation Overview
- Map legislation, assess conformity route, compile technical file, issue DoC, affix mark.
- Applies to manufacturers/importers of covered products; all sizes, EEA-focused.
- Audit-ready documentation; NB certification where required; post-market surveillance essential.
Key Differences
| Aspect | NIS2 | CE Marking |
|---|---|---|
| Scope | Cybersecurity risk management, incident reporting for critical sectors | Product health, safety, environmental conformity for specific categories |
| Industry | Essential/important entities in EU sectors like energy, transport | Manufacturers of electrical, machinery, medical devices in EEA |
| Nature | Mandatory EU directive, national transposition, fines enforcement | Manufacturer self-declaration under harmonised legislation |
| Testing | Risk assessments, incident response plans, no notified bodies | Conformity modules, notified body for high-risk, lab testing |
| Penalties | Up to 2% global turnover or €10M fines | Market withdrawal, fines, no fixed percentage specified |
Scope
Industry
Nature
Testing
Penalties
Frequently Asked Questions
Common questions about NIS2 and CE Marking
NIS2 FAQ
CE Marking FAQ
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