🩺NIS2 for Medical Device Manufacturing — deadlines, obligations, fines
Medical Device Manufacturing fall under NIS2 (Directive (EU) 2022/2555 + Romanian Emergency Ordinance 155/2024). See Art.21 obligations, deadlines, max fines and compliance roadmap for Annex II.
📋 Key obligations
- ▸ MDR + NIS2 combined compliance
- ▸ Cybersecurity by design (FDA + EU MDR)
- ▸ Audit anual
- ▸ SBOM (Software Bill of Materials) per device
- ▸ Plan continuitate suport
⚠️ Typical threats
- • Atacuri pe device-uri connected (pompe insulină, pacemakere)
- • Supply chain pe firmware
- • Espionaj IP
💰 Maximum fines
Max 7 mil. EUR sau 1.4% cifra afaceri
📊 Romania compliance status
Producători RO (Romsoft Medical, Optimasonic) în implementare.
🛡️ How CAI Technology helps
AEGIS — Observability + SecOps with AI
Unified SIEM for on-premise DCs: logs + metrics + threat detection + AI incident analysis.
ARTEMIS — AI Pentest · Hunt · Reveal · Strike
Autonomous pentest platform with 5 AI agents and 6 audit types. From 2€ per scan, no subscription.
CAI-AUTH — Post-Quantum Identity Provider
OIDC IdP built in Romania with post-quantum cryptography (hybrid post-quantum signatures). Patent Pending.
Lexnomia — EU Compliance Audit Platform
Self-serve compliance audit across 7+ EU regulations: GDPR, NIS2, DORA, EU AI Act, ISO 27001, CRA, DSA.
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