Learn how to document scope, the EMC assessment, standards, test results and the conformity procedure for apparatus.
What does the EMC Directive cover?
Directive 2014/30/EU distinguishes apparatus from fixed installations. Apparatus placed on the market is subject to conformity assessment, technical documentation, a declaration and CE marking, while fixed installations follow specific provisions.
Determine whether the product falls within scope and check exclusions, including equipment fully covered by more specific legislation.
EMC Directive or RED: not both
Where a product qualifies as radio equipment under Radio Equipment Directive 2014/53/EU, the RED applies instead of the EMC Directive. The two Directives are therefore not both listed as applicable legislation for the same product. The EU Declaration of Conformity for radio equipment refers to the RED, not additionally to the EMC Directive.
Electromagnetic compatibility must still be assessed. Article 3(1)(b) of the RED incorporates the level of protection set out in the EMC Directive. EMC standards, assessments and tests may therefore remain necessary, but they support conformity with the RED.
A product without radio functionality may fall under the EMC Directive. Where a product falls outside both scopes or more specific EU legislation governs these requirements, neither Directive may apply. Always assess the complete end product, its intended functions and every configuration.
What is an EMC assessment?
The assessment addresses relevant electromagnetic phenomena and intended operating conditions. Equipment must not generate disturbance that prevents radio, telecommunications or other equipment from operating as intended and must have adequate immunity.
Assess configurations, cables, power supplies, enclosures and accessories that affect EMC performance.
Standards, testing and technical justification
Harmonised standards may provide a presumption of conformity for covered requirements. Select standards based on product type, environment and functions and record which parts were applied.
Where standards are not applied or are only partly applied, describe the technical solutions and justification. Test results must be traceable to the assessed configuration.
What belongs in an EMC dossier?
Technical documentation contains the product description, design and manufacturing information, diagrams, applied standards or alternatives, calculations, examinations and test reports. It should also clearly include an adequate risk analysis and the relevant EMC assessment.
Retain design decisions such as filtering, grounding, shielding and cable routing together with their supporting evidence.
Conformity assessment and declaration
Article 14 allows internal production control or EU-type examination followed by conformity to type based on internal production control. Select and document the procedure used.
Once conformity is demonstrated, issue the EU Declaration of Conformity and affix CE marking. Documentation and declaration are generally retained for ten years.
How DME-CE supports the EMC Directive
The questionnaire in DME-CE helps determine whether the EMC Directive is relevant to the product and its intended functions and selects the applicable essential requirements. Where the product falls under the RED, the EMC Directive is not additionally selected as a separate legal framework; electromagnetic compatibility is addressed within the RED assessment.
Teams record assessed configurations, EMC phenomena, applied standards and design measures and connect them to examinations and test reports. This keeps the evidence for each requirement and product revision visible and shows which aspects still require substantiation.
DME-CE connects assessment, evidence and the declaration, but does not independently determine whether a configuration technically meets the EMC requirements. That assessment remains the responsibility of the manufacturer and competent specialists.