| Scope boundary | Focus on the product or combination supplied as a single functional unit for the end user, including components or sub-assemblies intended for end-user incorporation and mobile installations. | Focus on the permanent site combination, its geographical boundary, its external interfaces, and the electromagnetic environment at the predefined location. | Draw the product boundary and the site boundary separately. A product may be apparatus even when it will later be incorporated into a fixed installation. |
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| Covered actors | The apparatus route turns on making available or placing apparatus on the Union market, including the first making available of apparatus. | A fixed installation is put into service as a site installation rather than placed on the market as apparatus. | Use apparatus checks for commercial supply of end-user equipment; use fixed-installation checks for the installed site combination. |
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| Trigger | Apparatus is intended for the end user and must be assessed for normal intended operating conditions and representative configurations. | A fixed installation is intended for permanent use at a defined location and must respect the intended-use information for its components. | Do not classify only by hardware type. The intended user, intended use, mobility, and location permanence are part of the EMC category decision. |
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| Core obligations | The manufacturer designs and manufactures for Annex I essential requirements, prepares technical documentation, performs or has performed the conformity assessment, draws up the EU declaration of conformity, and affixes CE marking. | The person responsible for the fixed installation documents good engineering practices and keeps that documentation available for national authorities while the installation operates. | Apparatus compliance is a product conformity route. Fixed-installation compliance is a site engineering and documentation route. |
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| Evidence record | Keep the apparatus EMC assessment, risk analysis, design and manufacturing information, applied harmonised standards or other technical specifications, examinations, test reports, EU declaration, CE marking evidence, instructions, and traceability information. | Keep the installation boundary, component instructions, EMC environment assumptions, interface analysis, cable and screening choices, earthing or bonding approach, filters or other mitigation, maintenance assumptions, and responsible-person record. | A fixed-installation file may reference apparatus declarations and instructions, but it still needs site evidence showing how the installed combination meets EMC requirements. |
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| Timing and deadlines | If apparatus is made available generally, all relevant apparatus provisions apply even if the apparatus will be incorporated into a fixed installation. | If apparatus is intended for incorporation into a particular fixed installation and is otherwise not made available on the market, Articles 6 to 12 and 14 to 18 are not compulsory for that apparatus, but special accompanying documentation is required. | Use the Article 19 exception narrowly. The evidence must identify the fixed installation, its EMC characteristics, and incorporation precautions. |
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| Enforcement | Harmonised standards published for the EMC Directive can support presumption of conformity for apparatus to the essential requirements they cover. | A fixed installation may use standards, codes of practice, and component instructions as part of good engineering practice, but the site-specific conditions still matter. | For apparatus, track the standards applied in the technical documentation and EU declaration. For fixed installations, record why the chosen practices fit the actual site. |
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| Overlap and reuse | Choose apparatus when the immediate question is whether an end-user product can be supplied, CE marked, declared, imported, distributed, or supported on the Union market. | Choose fixed installation when the immediate question is whether a permanent site combination has been installed with suitable EMC practices and documented for the responsible person. | Choose both when market-supplied apparatus is incorporated into a permanent site installation; keep the product evidence and site evidence linked but distinct. |
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| Practical decision rule | For apparatus, authorities may request information and documentation needed to demonstrate conformity, and non-conforming apparatus can require corrective action, withdrawal, or recall. | For fixed installations, authorities may request evidence where there are indications of non-compliance, especially disturbance complaints, and may require measures to bring the installation into compliance. | Prepare different response packs: a product technical file for apparatus and a site compliance file for fixed installations. |
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