| Scope boundary | Machinery covers machinery, listed related products, and partly completed machinery. The Machinery Regulation also contains exclusions for specified electrical and electronic products when they fall within Directive 2014/35/EU or Directive 2014/53/EU. | RED is the radio-equipment side of the file. The grounding data supports identifying 2014/53/EU as Radio equipment legislation and as an active EU conformity-assessment legislation entry. | Decide first whether the item is the complete machine, a related product, or the wireless element that may fall under 2014/53/EU. That tells you which file must lead. |
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| Covered actors | Machinery evidence should show how the machine or related product meets applicable essential health and safety requirements, including risks created by control systems or components that affect the safe operation of the machine. | The RED workstream should stay limited to the radio-equipment question and any radio/EMC/safety evidence available for that element; do not use the machinery file to invent unsupported RED requirements. | If the radio part helps the machine work safely, keep the machinery hazard map as the lead record and attach the radio evidence underneath it. |
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| Trigger | For machinery or related products, the manufacturer file should include the risk assessment, EHSR matrix, technical documentation, instructions, conformity assessment route, EU declaration of conformity, and CE marking review. | For the radio-equipment side, keep supplier/module declarations, test records, and identification evidence with clear labels showing whether they support the module, the final machine, or both. | Start the file with the law that controls the main product boundary, then add the other regime only for the records that really support the radio-enabled part. |
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| Core obligations | Machinery remains the controlling workstream for machinery hazards and EHSRs unless a more specific EU law covers the relevant risk for the relevant product boundary. | RED may govern where the radio-enabled element falls within radio-equipment legislation or where the Machinery Regulation's electrical/electronic exclusion points the product out of machinery scope to Directive 2014/53/EU. | Use Machinery first for the machine's safety file, then open RED for the wireless element only if the radio equipment law applies to that element. |
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| Evidence record | Machinery covers machinery, listed related products, and partly completed machinery. The Machinery Regulation also contains exclusions for specified electrical and electronic products when they fall within Directive 2014/35/EU or Directive 2014/53/EU. | RED is the radio-equipment side of the file. The grounding data supports identifying 2014/53/EU as Radio equipment legislation and as an active EU conformity-assessment legislation entry. | Tag the evidence by product boundary: machine file for the machinery item, radio file for the wireless module or radio equipment, and only shared records where both laws are actually supported. |
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| Timing and deadlines | Machinery covers machinery, listed related products, and partly completed machinery. The Machinery Regulation also contains exclusions for specified electrical and electronic products when they fall within Directive 2014/35/EU or Directive 2014/53/EU. | RED is the radio-equipment side of the file. The grounding data supports identifying 2014/53/EU as Radio equipment legislation and as an active EU conformity-assessment legislation entry. | Do not treat timing as a generic shared deadline. Put the machine on the Machinery timeline, and only add a RED timeline if the radio equipment scope actually applies. |
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| Enforcement | Machinery covers machinery, listed related products, and partly completed machinery. The Machinery Regulation also contains exclusions for specified electrical and electronic products when they fall within Directive 2014/35/EU or Directive 2014/53/EU. | RED is the radio-equipment side of the file. The grounding data supports identifying 2014/53/EU as Radio equipment legislation and as an active EU conformity-assessment legislation entry. | Answer the enforcement question by asking which authority would review the relevant product boundary and evidence package. That is usually the machinery file for the machine and the radio file for the module. |
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| Overlap and reuse | Machinery covers machinery, listed related products, and partly completed machinery. The Machinery Regulation also contains exclusions for specified electrical and electronic products when they fall within Directive 2014/35/EU or Directive 2014/53/EU. | RED is the radio-equipment side of the file. The grounding data supports identifying 2014/53/EU as Radio equipment legislation and as an active EU conformity-assessment legislation entry. | Reuse only the records that stay true when the product boundary changes; a module test report can support the machine file, but only for the radio claim it actually covers. |
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| Practical decision rule | Machinery covers machinery, listed related products, and partly completed machinery. The Machinery Regulation also contains exclusions for specified electrical and electronic products when they fall within Directive 2014/35/EU or Directive 2014/53/EU. | RED is the radio-equipment side of the file. The grounding data supports identifying 2014/53/EU as Radio equipment legislation and as an active EU conformity-assessment legislation entry. | Lead with Machinery when the question is machine safety, and lead with RED when the question is the radio-enabled item itself. If both are in play, keep the two scopes separate and only share evidence by reference. |
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