Directive 2014/30/EU requires apparatus to meet electromagnetic compatibility essential requirements before it is placed on the EU market.
Use this page to structure the manufacturer assessment, technical file, EU declaration of conformity, CE marking, instructions, and evidence records for EMC Directive apparatus.
Structured answer sets in this page tree.
Cited legal and guidance references.
For apparatus under the EMC Directive, conformity assessment is not just a lab report. The manufacturer must demonstrate compliance with the Annex I essential requirements, choose the applicable assessment route under Article 14, prepare technical documentation, draw up the EU declaration of conformity, affix CE marking, and keep the required evidence available for authorities.
Article 14 gives the manufacturer two routes for apparatus. The first is Annex II internal production control, where the manufacturer performs the EMC assessment, establishes technical documentation, controls manufacturing, affixes CE marking, and issues the EU declaration of conformity on its own responsibility.
The second route is Annex III: EU-type examination by a notified body, followed by conformity to type based on internal production control. The manufacturer can use this route for some aspects of the essential requirements and use Annex II for the remaining aspects.
Annex II and Annex III both require technical documentation that makes it possible to assess apparatus conformity. The file must include an adequate analysis and assessment of EMC risks and cover the design, manufacture, and operation of the apparatus as far as relevant.
A practical EMC technical file should connect the apparatus identification in the declaration, the product drawings and circuit information, the EMC assessment, the standards or alternative specifications used, the test reports, and the manufacturing controls. That link is important because Article 7 requires the manufacturer to keep the technical documentation and EU declaration of conformity for 10 years after the apparatus has been placed on the market.
Use this page to check whether the apparatus file connects the EMC assessment, standards or alternative specifications, test reports, EU declaration of conformity, CE marking, instructions, and retention evidence.
Article 13 gives a presumption of conformity only for equipment that conforms with harmonised standards, or relevant parts of them, whose references have been published in the Official Journal of the European Union. The technical file should therefore show the exact dated standard references used and which essential requirements they cover.
Commission Implementing Decision (EU) 2019/1326 publishes and withdraws EMC harmonised-standard references. Because the published list changes, a release review should confirm the standard reference still supports presumption of conformity for the apparatus and should preserve any transition or withdrawal rationale used for that model.
The EU declaration of conformity must state that fulfilment of the Annex I essential requirements has been demonstrated, follow the model structure in Annex IV, contain the elements from the relevant modules, and be kept continuously updated. Where multiple Union acts require an EU declaration for the same apparatus, Article 15 allows a single declaration covering all of them, with the Union acts identified.
CE marking is the visible result of the conformity assessment process. Under Article 17 it must be affixed visibly, legibly, and indelibly to the apparatus or data plate; where that is not possible or not warranted because of the apparatus nature, it goes on the packaging and accompanying documents. The marking must be affixed before the apparatus is placed on the market.
"references of harmonised standards"
"for 10 years"