Classify the equipment before choosing the EMC route. Apparatus normally needs product conformity assessment, an EU declaration of conformity, and CE marking; a instead needs site-specific engineering and operating-life records.
The narrow exception for apparatus made only for one identified does not apply when that apparatus is otherwise made available on the market.
Classify the equipment before choosing the EMC evidence route. Apparatus is a finished appliance or combination made available as one functional unit for an end user; certain end-user components, sub-assemblies, and mobile installations are also treated as apparatus. A is a particular combination of several types of apparatus and, where applicable, other devices, assembled for permanent use at a predefined location. Apparatus normally follows the conformity-assessment, EU declaration of conformity, and CE-marking route. The fixed installation itself does not follow that apparatus marking route; the responsible person must instead document site-specific good engineering practices for as long as the installation operates.
Side-by-side comparison
Apparatus vs Fixed Installations under the EMC Directive
This table helps decide whether the EMC work belongs in a product conformity route, a site-specific installation route, or both.
A finished appliance, qualifying combination, component or sub-assembly, or mobile installation made available for end use and capable of causing or being affected by electromagnetic disturbance.
Second framework
Fixed installations
A particular combination of apparatus and, where relevant, other devices that is assembled, installed, and intended to be used permanently at a predefined location.
Apparatus vs Fixed Installations under the EMC Directive
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 .
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 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.
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.
Explains that simple fixed installations may rely on supplier installation, use, and maintenance instructions, while complex installations may need more detailed documentation.
If apparatus is made available generally, all relevant apparatus provisions apply even if the apparatus will be incorporated into a .
If apparatus is intended for incorporation into a particular 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 , its EMC characteristics, and incorporation precautions.
Harmonised standards published for the EMC Directive can support presumption of conformity for apparatus to the essential requirements they cover.
A 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.
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 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.
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.
Articles 7, 9, 10, and 19 describe authority requests, corrective measures, and fixed-installation evidence requests.
request evidence of compliance
Scope boundary
Apparatus
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.
Fixed installations
Focus on the permanent site combination, its geographical boundary, its external interfaces, and the electromagnetic environment at the predefined location.
Operational implication
Draw the product boundary and the site boundary separately. A product may be apparatus even when it will later be incorporated into a .
Clarifies that end users may be consumers or legal entities using apparatus for its intended purpose.
using or intending to use the apparatus for its intended purpose
Core obligations
Apparatus
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.
Fixed installations
The person responsible for the 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.
Operational implication
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.
Articles 7, 14 to 18, and 19 separate apparatus conformity assessment and marking from fixed-installation documentation.
affix the CE marking
Evidence record
Apparatus
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.
Fixed installations
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.
Operational implication
A fixed-installation file may reference apparatus declarations and instructions, but it still needs site evidence showing how the installed combination meets EMC requirements.
Explains that simple fixed installations may rely on supplier installation, use, and maintenance instructions, while complex installations may need more detailed documentation.
level of detail of the documentation
Timing and deadlines
Apparatus
If apparatus is made available generally, all relevant apparatus provisions apply even if the apparatus will be incorporated into a .
Fixed installations
If apparatus is intended for incorporation into a particular 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.
Operational implication
Use the Article 19 exception narrowly. The evidence must identify the , its EMC characteristics, and incorporation precautions.
Adds practical guidance that the exception depends on a direct provider-customer link and the identified installation characteristics.
particular fixed installation
Standards and engineering basis
Apparatus
Harmonised standards published for the EMC Directive can support presumption of conformity for apparatus to the essential requirements they cover.
Fixed installations
A may use standards, codes of practice, and component instructions as part of good engineering practice, but the site-specific conditions still matter.
Operational implication
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.
Lists harmonised standards drafted in support of Directive 2014/30/EU.
drafted in support of Directive 2014/30/EU
Overlap and reuse
Apparatus
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.
Fixed installations
Choose when the immediate question is whether a permanent site combination has been installed with suitable EMC practices and documented for the responsible person.
Operational implication
Choose both when market-supplied apparatus is incorporated into a permanent site installation; keep the product evidence and site evidence linked but distinct.
Commission guide emphasizes identifying the correct category because the Directive has separate provisions for each.
separate provisions
Authority response
Apparatus
For apparatus, authorities may request information and documentation needed to demonstrate conformity, and non-conforming apparatus can require corrective action, withdrawal, or recall.
Fixed installations
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.
Operational implication
Prepare different response packs: a product technical file for apparatus and a site compliance file for fixed installations.
Articles 7, 9, 10, and 19 describe authority requests, corrective measures, and fixed-installation evidence requests.
request evidence of compliance
Practical decision rule
How should teams decide between apparatus and fixed-installation evidence?
If the item is commercially supplied for end use, build the apparatus evidence pack before placing it on the Union market.
If the issue is a permanent site combination, build the fixed-installation record around good engineering practice, component intended-use information, site boundaries, interfaces, and the responsible person.
If a bespoke item is only for one particular and is otherwise not made available, document why the Article 19 specific-apparatus route applies and keep the required accompanying documentation.
Primary source for the classification and evidence decision between apparatus, fixed installations, and specific apparatus for a particular fixed installation.
Guidance source for applying the classification and documentation distinction in practice.
Specific apparatus for fixed installations
1
Section 1
Classify the equipment before assigning EMC duties
Start with the commercial and technical facts. If the item is supplied on the Union market as a single functional unit for an end user and it can generate or be affected by electromagnetic disturbance, treat it as apparatus unless an exclusion applies or another Union law lays down the same EMC requirements more specifically.
If the project is a site-specific combination assembled and intended to stay permanently at a predefined location, treat the site combination as a . The incorporated apparatus normally keeps its apparatus duties, unless the narrow Article 19 case applies for apparatus intended only for a particular fixed installation and otherwise not made available on the market.
For example, a commercially supplied combination of programmable logic controllers and motor drives can be one apparatus when it is sold as a single functional unit for an end user; combining CE-marked products does not automatically make that system EMC-compliant. A factory production line assembled for permanent use at one identified site can be a . A mobile installation is treated as apparatus, not as a fixed installation. These are category examples, and the marketed unit, intended user, mobility, and site facts still control the result.
Record whether the item is made available on the Union market, placed on the market for the first time, or only incorporated into one identified .
Check whether the intended user is an end user, an installer or integrator, or the person responsible for a .
Separate the apparatus technical file from the fixed-installation site file so CE marking evidence is not confused with site engineering evidence.
Commission EMCD guide used for the practical classification between apparatus, fixed installations, and specific apparatus for fixed installations.
correct category of equipment
2
Section 2
Documentation differs by route
For apparatus, the manufacturer must support conformity before placing the apparatus on the market. The record should cover the EMC assessment, applicable harmonised standards or other technical solutions, risk analysis, test reports where relevant, EU declaration of conformity, CE marking, identification, contact details, instructions, and specific installation or use precautions.
For fixed installations, the central record is not a product CE-marking file. It should show the installation boundary, incorporated apparatus and other devices, component instructions used, EMC environment, good engineering practices applied, precautions, responsible person, and any evidence needed if authorities request proof following disturbance complaints or other indications of non-compliance.
Keep apparatus technical documentation and the EU declaration of conformity for 10 years after the apparatus is placed on the market.
Keep documented good engineering practices for the for as long as the installation is in operation.
For specific apparatus used only in a particular , include the apparatus identity, manufacturer or importer details, the fixed installation identity and EMC characteristics, and incorporation precautions.
Explains fixed-installation documentation detail, good engineering practice, component instructions, and specific-apparatus documentation.
Identification of fixed installation
Recommended next step
Turn the EMC category decision into an evidence pack
Document whether the matter is apparatus, a fixed installation, or specific apparatus for a particular fixed installation, then attach the right technical file, site file, and source citations.
Good engineering practice is a fixed-installation control
A must be installed using good engineering practices and the information on the intended use of its components. In practical EMC records, that means defining the installation boundary, external interfaces, conducted and radiated disturbance paths, cable and screening choices, earthing or bonding approach, filters or protection devices, and immunity measures for sensitive equipment.
This is site-specific evidence. CE markings and declarations for incorporated apparatus do not, by themselves, show that the installed combination meets the fixed-installation requirements. For a simple installation, the record may be limited to the suppliers' installation, use, and maintenance instructions plus evidence that the installer followed them. A complex installation needs enough additional analysis to show why the chosen practices fit the site and its electromagnetic environment.
Do not use a fixed-installation file as a substitute for apparatus conformity assessment where market-supplied apparatus is involved.
Do not assume a CE-marked apparatus makes the whole compliant without checking site coupling, interfaces, intended use, and installation precautions.
Revisit the site record when equipment, cabling, location, power supply, radio environment, operating mode, or maintenance assumptions change.
Article 19 states the general apparatus rule and the limited exception for apparatus intended for a particular fixed installation.
Article 13 provides presumption of conformity for equipment meeting cited harmonised standards for the covered essential requirements.
The Directive defines both categories and applies different provisions to apparatus and fixed installations.
Articles 7, 9, 10, and 19 describe authority requests, corrective measures, and fixed-installation evidence requests.
Primary source for the classification and evidence decision between apparatus, fixed installations, and specific apparatus for a particular fixed installation.
"apparatus or fixed installation"
More quoted passages
"‘equipment’ means any apparatus or fixed installation"
Commission guidance source for classification, apparatus documentation, fixed-installation procedures, good engineering practice, and specific apparatus for fixed installations.
Commission EMCD guide used for the practical classification between apparatus, fixed installations, and specific apparatus for fixed installations.
Explains fixed-installation documentation detail, good engineering practice, component instructions, and specific-apparatus documentation.
Show 7 more
Provides practical fixed-installation factors such as boundaries, ports, coupling, radiation, filters, cable choices, screening, and earthing.
Explains that the EMCD applies to equipment placed on the market and subsequent making available until it reaches the end user.
Clarifies that end users may be consumers or legal entities using apparatus for its intended purpose.
Explains that simple fixed installations may rely on supplier installation, use, and maintenance instructions, while complex installations may need more detailed documentation.
Adds practical guidance that the exception depends on a direct provider-customer link and the identified installation characteristics.
Commission guide emphasizes identifying the correct category because the Directive has separate provisions for each.
Guidance source for applying the classification and documentation distinction in practice.
"Classification as apparatus or fixed installation"
More quoted passages
"correct category of equipment"
"Identification of fixed installation"
"EMC purposes at the specific site"
"reaches the end-user"
"using or intending to use the apparatus for its intended purpose"