What It Is

The NIS2 Directive, officially Directive (EU) 2022/2555, is an EU regulation expanding the original NIS Directive to achieve high cybersecurity levels across member states. It targets essential and important entities in broadened sectors like energy, transport, health, digital infrastructure, and public administration via a size-cap rule (50+ employees or €10M turnover). It adopts a risk-based, all-hazards approach emphasizing resilience and proactive measures.

Key Components

• **Risk managementOngoing assessments, supply chain security, access controls, encryption.
• **Incident reporting24-hour early warning, 72-hour detailed notification, one-month final report to CSIRTs.
• **Corporate accountabilitySenior management and boards directly responsible.
• **Business continuityRecovery plans, crisis procedures.

Enforced by national authorities with spot checks; transposition deadline October 2024.

Why Organizations Use It

• Meets legal obligations, avoids fines up to €10M or 2% global turnover.
• Builds cyber resilience against threats like APTs, ransomware.
• Enhances trust, continuity, aligns with ISO 27001/NIST.
• Supports cross-border cooperation.

Implementation Overview

Requires gap analysis, policy/process updates, training, reporting systems. Applies EU-wide to qualifying entities; ongoing monitoring essential. Tailor to national variations; leverage standards for efficiency. (178 words)

What It Is

ISO 13485:2016, titled Medical devices — Quality management systems — Requirements for regulatory purposes, is an international certification standard for QMS in medical device organizations. It applies a risk-based approach across the device lifecycle, from design to post-market surveillance, ensuring consistent conformity to customer and regulatory requirements.

Key Components

• Organized into Clauses 4–8: QMS/documentation (4), management responsibility (5), resources (6), product realization (7), measurement/improvement (8).
• Emphasizes documented procedures, validation, traceability, risk management (linked to ISO 14971), supplier controls, and post-market activities.
• Built on process approach; requires certification via accredited bodies with stage audits and surveillance.

Why Organizations Use It

• Enables market access (EU MDR, FDA QMSR alignment by 2026), reduces risks/recalls, ensures supply chain resilience.
• Builds stakeholder trust, cuts cost of quality, supports scalability and regulatory convergence.

Implementation Overview

• Phased: gap analysis, process design, documentation, validation, audits, certification (9–18 months typical).
• Applies to manufacturers, suppliers, distributors globally; suits SMEs to multinationals via tailored scope.