Machinery Regulation Conformity Assessment Routes: Module A, Module B+C, and Module H Compared
What conformity assessment modules are available under Machinery Regulation (EU) 2023/1230? Regulation (EU) 2023/1230 establishes three primary conformity assessment procedures detailed in Article 25: Module A (Internal Production Control, Annex VIII), Module B followed by Module C (EU Type-Examination followed by Conformity to Type based on Internal Production Control, Annex IX & X), and Module H (Full Quality Assurance, Annex X). Module A is the standard route for over 90% of industrial machinery not listed in Annex I; Annex I Part A machines strictly require Module B+C or Module H, while Annex I Part B machines require Notified Body intervention only if harmonized standards are not applied in full.
Detailed comparison of Module A (Internal Production Control), Module B+C (EU Type-Examination), and Module H (Full Quality Assurance) under Regulation (EU) 2023/1230.
Technical Specifications & Regulatory Comparison Matrix
| Module | Official Name | Notified Body Required? | Best Suited For | Cost & Timeline Impact |
|---|---|---|---|---|
| Module A | Internal Production Control | No (Manufacturer self-declaration) | Standard machinery, serial packaging lines, conveyors | |
| Module B + C | EU Type-Examination + Conformity to Type | Yes (Module B testing of prototype by Notified Body) | Annex I machinery, innovative prototypes, unique custom units | |
| Module H | Full Quality Assurance | Yes (ISO 9001-style audit of design & manufacturing) | High-volume Annex I manufacturers with mature QM systems | |
| Module G | Unit Verification | Yes (Notified Body tests individual custom machine) | One-off massive industrial plants, heavy tunnel boring machines |
1. Module A: Internal Production Control (Annex VIII)
Under Module A, the manufacturer compiles the technical file, implements quality measures to ensure serial production conforms to the design, affixes the CE mark, and signs the EU Declaration of Conformity. No Notified Body is involved. However, the manufacturer assumes full civil and criminal liability for compliance with all applicable EHSRs.