| Scope boundary | Is the product machinery, a related product, or partly completed machinery under Regulation (EU) 2023/1230, and which Machinery obligations follow from that classification? | Does the equipment need a separate EMC assessment for electromagnetic disturbance or immunity under Directive 2014/30/EU? | A powered machine with electronics can need both files: Machinery for safety risks and EMC for electromagnetic compatibility. |
|---|
|
| Covered actors | Machinery starts from hazards, EHSRs, risk assessment, risk reduction, residual risks, and instructions for safe use. | EMC starts from electromagnetic disturbance and immunity evidence; do not use EMC tests as a substitute for the machinery hazard analysis. | Keep separate matrices: one EHSR and risk-reduction matrix for Machinery, one EMC standards and test-evidence matrix for EMC. |
|---|
|
| Trigger | Machinery standards support presumption or evidence of conformity only for the EHSRs they cover; the declaration should identify applied standards and any partial application. | EMC standards support the EMC claim; they should be listed as EMC evidence, not as proof that the machine safety risk assessment is complete. | Create one standards register with columns for regime, requirement, edition, OJEU or source status, test or design evidence, and limits of reliance. |
|---|
|
| Core obligations | Machinery documentation should include the EHSR analysis, risk assessment, design and manufacturing information, instructions, conformity-assessment records, and declaration. | EMC documentation should include the EMC standards, test plan, test reports, design assumptions, and declaration evidence used for the EMC claim. | A combined technical file is acceptable only if reviewers can see which document supports Machinery, EMC, or both. |
|---|
|
| Evidence record | The Machinery declaration identifies the machinery or related product and the Union harmonisation legislation and standards used for the Machinery conformity claim. | Where EMC also applies, the CE declaration set should identify Directive 2014/30/EU separately rather than hiding EMC under the Machinery entry. | Before affixing CE marking, check that each applicable regime has supporting assessment records and a declaration entry. |
|---|
|
| Timing and deadlines | Machinery remains the safety framework, but Article 9 allocates risks to more-specific Union harmonisation legislation where that legislation wholly or partly covers the same EHSR risk. | EMC should be treated as the more-specific workstream for electromagnetic compatibility issues, while Machinery still covers the machine safety hazards not displaced by a specific law. | Do not delete Machinery requirements wholesale; allocate specific risks and keep a written rationale for each allocation. |
|---|
|
| Enforcement | Partly completed machinery follows the Machinery Regulation route for assembly instructions, relevant EHSRs, and an EU declaration of incorporation. | Any EMC work for the component or final assembly should be mapped separately so downstream integrators know which assumptions, installation conditions, and tests they can rely on. | Do not convert a partly completed machinery file into a finished-machine CE pack unless the final machinery conformity assessment has been completed. |
|---|
|
| Overlap and reuse | When Machinery and EMC both apply, keep the machinery safety case and the EMC evidence in separate sections of the same file so each requirement stays traceable. | Treat EMC as a parallel compliance file, not as a substitute for the machinery risk assessment or EHSR matrix. | Reuse design data where it helps both regimes, but record the legal basis, the test basis, and the requirement each item supports. |
|---|
|
| Practical decision rule | Start with Machinery when the product is a machine, related product, or partly completed machinery and you need the safety file, EHSR review, risk reduction record, instructions, and declaration of conformity. | Start with EMC when the item is electrical or electronic apparatus whose main remaining question is electromagnetic disturbance or immunity under Directive 2014/30/EU. | If both apply, finish the machinery safety file first, then add EMC evidence and a separate EMC declaration entry so the final CE pack shows both legal bases clearly. |
|---|
|