| 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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| Market event | 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. The fixed installation itself is not CE marked or covered by an EU declaration of conformity under the apparatus route. | Apparatus compliance is a product conformity route. Fixed-installation compliance is a site engineering and documentation route; CE-marked incorporated apparatus does not establish compliance of the installed combination by itself. |
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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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| Standards and engineering basis | 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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| Authority response | 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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