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Testing & Conformity BodiesModule B + C / HImportant Class IIAudited: September 2026 (Active SRP Era)

TÜV SÜD CRA Service

Accredited European Notified Body & Formal EU-Type Examination Inspection

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Executive Conformity Assessment Verdict

The gold standard for legal CE mark certitude. Essential for manufacturers of Important Class II products where third-party conformity assessment is a non-negotiable statutory mandate.

Accredited European testing and certification giant providing formal Notified Body inspection and EU-Type examination audits.

Verified Pricing Tier€1,800 – €3,200 / day
Deployment ModelAccredited CAB
Applicable CRA RouteModule B + C / H
Target Product TierImportant Class II
Statutory Audit

Statutory Capability & Article Coverage Matrix

How TÜV SÜD CRA Service performs against non-negotiable statutory mandates of Regulation (EU) 2024/2847.

Technical Documentation Dossier
Annex VIIIngest & Link Rails
EU Declaration of Conformity
Annex VNative Auto-Dossier
Coordinated Vulnerability Disclosure (CVD)
Article 10 & RFC 9116Workflow Only
24-Hour ENISA Early Warning Dispatch
Article 14 (Active Sept 2026)No
Substantial Modification Diff Engine
Article 22Manual Check
Binary Firmware Disassembly & SCA
Annex I Part I (1)(a)Hardware Lab Only
Air-Gapped / Island-Mode Deployment
Data Sovereignty & IP ProtectionBespoke Consulting
Multi-Act Cross-Walk Coverage:CRA (EU) 2024/2847Machinery Directive/RegRED DirectivePressure Equipment
Technical Architecture

Architectural Fit & Deployment Analysis

Formal conformity assessment body. Inspects the manufacturer's technical dossier, tests representative device samples in accredited anechoic and cybersecurity chambers, and verifies quality management.

Provides legal safe harbor. When TÜV SÜD issues an EU-Type Examination Certificate, national market surveillance authorities presume the product satisfies essential requirements.

Capacity crunch: In 2026, European Notified Bodies face a severe backlog. Booking an audit slot must be planned 9 to 12 months in advance to avoid shipping delays.

Verified Key Strengths
Internationally recognized brand providing unassailable regulatory credibility with European authorities
Accredited testing laboratories across Germany, Europe, and Asia for physical and radio testing
Statutory authority to issue official EU-Type Examination certificates under Module B and Module H
Deep institutional expertise in industrial automation (IEC 62443) and functional safety
Structural Limitations & Gaps
Severe industry-wide Notified Body capacity bottleneck resulting in multi-month waiting lists
High day-rate billing structure making certification expensive for smaller manufacturers
Manual, documentation-intensive process that can slow down agile software release cycles
Commercial Model

Pricing, Packaging & Total Cost of Ownership (TCO)

€1,800 – €3,200 / day
Entry Tier
Gap Assessment: €10,000 – €20,000 (Preliminary technical documentation readiness review)
Mid / Scale Tier
Module B Inspection: €30,000 – €60,000 (Formal EU-Type Examination for Class I/II products)
Enterprise Tier
Module H Certification: €80,000 – €150,000+ (Full quality assurance system certification)
Hidden Cost Factors:
  • Travel expenses for on-site facility audits
  • Annual surveillance and re-audit fees
TCO Verdict:Significant capital expense; mandatory for Class II products and Class I products lacking harmonized standards.
Statutory Honesty Notice • Article 32 & Article 24

A Notified Body cannot write your technical file for you. Arriving at an audit with an incomplete Annex VII dossier will result in immediate rejection and billable re-audit charges.

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