CE Marking Technical File for Machinery: Complete 2027 Requirements and Document Structure
What documents must be included in the Machinery Technical Construction File under Regulation (EU) 2023/1230? Under Annex IV Part A of Regulation (EU) 2023/1230, the Technical Construction File (TCF) must include: a general description of the machinery, overall assembly drawings and control circuit schematics, detailed design calculations and test results, a comprehensive risk assessment carried out in accordance with EN ISO 12100, the documentation of risk reduction measures, assessment of cybersecurity vulnerabilities for control circuits (Annex III 1.1.9), the list of harmonized standards applied, test reports proving structural and electrical safety, copy of user instructions in required languages, and the signed EU Declaration of Conformity. The file must be kept available for market surveillance authorities for at least 10 years.
Exact structure, required calculation reports, cybersecurity assessments, and risk analysis documents for the 2027 CE Technical Construction File.
Technical Specifications & Regulatory Comparison Matrix
| TCF Chapter | Required Documentation | Reference Standards | Mandatory Retention |
|---|---|---|---|
| Chapter 1: General Description | Functional specs, machine rating plate drawing, serial layout | EN ISO 12100 Clause 5 | 10 years |
| Chapter 2: Technical Drawings | Mechanical assembly, hydraulic/pneumatic diagrams, wiring schematics | EN 60204-1, ISO 4413, ISO 4414 | 10 years |
| Chapter 3: Risk Assessment | Identified hazards, severity/probability scores, residual risks | EN ISO 12100:2010 | 10 years |
| Chapter 4: Functional Safety | Performance Level (PL) calculations, SISTEMA reports, architecture Cat B-4 | EN ISO 13849-1:2023 / IEC 62061 | 10 years |
| Chapter 5: Cyber Risk Assessment | Network port inventory, access controls, protection against corruption | Annex III 1.1.9 / IEC 62443 | 10 years |
| Chapter 6: Test Reports | Noise measurement, EMC emissions/immunity, structural load tests | EN ISO 3744, EN 61000-6-2/4 | 10 years |
| Chapter 7: Manuals & Declarations | Operating instructions, maintenance manual, copy of EU Declaration | Annex III 1.7.4 / Article 10(7) | 10 years |
1. Functional Safety Validation (EN ISO 13849-1:2023)
Chapter 4 is the most heavily scrutinized section during market surveillance audits. Every safety function (e.g., interlocked guards, light curtains, emergency stops) must have an assigned Required Performance Level (PLr) and an achieved Performance Level (PL). The documentation must include component MTTFd values, Diagnostic Coverage (DC), Common Cause Failure (CCF) scores, and validation reports proving safety loops cannot be defeated.