- Commission DocsRoom record for national market-surveillance contact points under Directive 2014/30/EU.
"Market Surveillance under Directive 2014/30/EU"
For EMC apparatus, the release pack is not only a test report. It must connect the EU Declaration of Conformity, CE marking, traceability details, instructions, safety-use information, and any required market-language versions.
Use this page to check what belongs in the outward-facing package and what evidence must stay available for market surveillance.
Structured answer sets in this page tree.
Cited legal and guidance references.
Directive 2014/30/EU requires manufacturers to draw up technical documentation, complete the conformity assessment, issue an EU Declaration of Conformity, affix the CE marking, and keep the technical documentation and declaration for 10 years after apparatus is placed on the market. The packaging work is to make those records match the exact apparatus model and the language expectations of each Member State where the apparatus is placed or made available.
The EU Declaration of Conformity must state that the EMC essential requirements have been demonstrated, follow the Annex IV model structure, contain the elements required by the applicable conformity-assessment module, and stay continuously updated. If the apparatus is covered by more than one EU act requiring a declaration, the EMC Directive allows one declaration for all relevant Union acts, provided the acts and publication references are identified.
Treat the declaration as a traceability document. The package should identify the apparatus model, product type, batch or serial number; name and address of the manufacturer or authorised representative; the object of the declaration; the Union legislation covered; the harmonised standards or other technical specifications used, including dates; any notified-body intervention; and the signatory, place, and date.
The manufacturer must put its name, registered trade name or trade mark, and postal contact address on the apparatus. If that is not possible, the same information can go on packaging or an accompanying document. Importers have a parallel duty to show their own name, registered trade name or trade mark, and postal address on the apparatus, packaging, or an accompanying document.
Instructions and Article 18 use information must accompany the apparatus in a language easily understood by consumers and other end-users, as determined by the Member State concerned. The Article 18 pack should cover specific assembly, installation, maintenance, or use precautions needed for EMC conformity; any clear residential-use restriction where compliance is not ensured in residential areas; and information needed to use the apparatus as intended.
The CE marking must be visible, legible, and indelible on the apparatus or its data plate. If that is not possible or not warranted because of the apparatus nature, it must be placed on the packaging and accompanying documents. It must be affixed before the apparatus is placed on the market.
Packaging is also the fallback location for required identification or operator details when the apparatus size or nature does not allow marking on the apparatus itself. That makes the packaging review a regulatory review: the product identifier, CE marking location, manufacturer details, importer details where relevant, instructions, language versions, and EU Declaration of Conformity references should be checked together.
Check that the declaration, CE marking, translated instructions, operator details, packaging proofs, and retained evidence all point to the same apparatus and market release.
"Market Surveillance under Directive 2014/30/EU"
"for 10 years after the apparatus has been placed"
"EMC ADCO information sheet"
"affix the CE marking to a product"