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EMC Directive 2014/30/EU

New EMC Directive 2014/30/EU

Afternew emc directive 2014 April 2016, manufacturers, distributors and importers of EMC products should adapt the CE Marking conformity assessments processes to the new EMC Directive 2014/30/EU. Even though the main changes are quite limited, they should be known and taken into account.

Scope

The scope remains the same, however, ‘Custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes’ are now excluded from the Directive. The criteria and conditions under which custom build evaluation kit would be excluded are still under discussion.

Obligations for economic operators

‘Economic operators’ are manufacturers, authorized representatives, importer and distributors.

New, or enhanced, requirements for manufacturers include:

  • Manufacturers shall indicate, on the apparatus, their name, registered trade name or registered trade mark and the postal address at which they can be contacted, unless not possible, in which case it should be included on the packaging or in the accompanying documentation.
  • Equipment should bear a type, batch or serial number, or other element, allowing its identification, or, where the size or nature of the apparatus does not allow it, that the required information is provided on the packaging or in a document accompanying the apparatus.
  • Equipment must be accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users.
  • Manufacturers who have reason to believe that their equipment is not in conformity with 2014/30/EU shall immediately take corrective measures, withdraw it or recall it, as appropriate. Furthermore, where there is a risk to consumers, the appropriate competent National Authorities must be made aware of the non-conformity and any corrective measures taken

Additionally, Directive 2014/30/EU specifically details obligations of authorized representatives, importers and distributors. The requirements for importers have particularly been elaborated, and include:

  • Importers shall ensure that the appropriate conformity assessment procedure has been carried out by the manufacturer. They shall also ensure that the manufacturer has drawn up the technical documentation, that the apparatus bears the CE marking and is accompanied by the required documents.
  • Importers shall indicate their name, registered trade name or registered trade mark and the postal address at which they can be contacted on the apparatus (unless that is not possible, in which case it should be included on the packaging or in an accompanying document). This is additional to the Manufacturer’s details.
  • Importers shall ensure that apparatus is accompanied by instructions and safety information in an appropriate language.
  • Importers shall ensure that, while apparatus is under their responsibility, its storage or transport conditions do not jeopardize its compliance with the safety objectives.
  • Importers shall keep a copy of the EU declaration of conformity (for 10 years) and must ensure that this and the technical documentation are made available to the market surveillance authorities.

The new Directive also includes increased information regarding Notified Bodies, Notifying Authorities, and Penalties for serious infringements.

The EMC Directive 2014/30/EU is already published. Besides this the European Commission has already released draft guidance on new EMC Directive.

Express check

For express check of your product compliance with European EMC requirements, do the following steps:

  • Check revision dates of the harmonised standards listed in your documentation;
  • Review Annex IV EMC Directive 2014/30/EU and update the Declaration of Conformity accordingly:
    • Update the EMC Directive reference to 2014/30/EU
    • List all current revisions of the harmonized standards applied
    • Clearly identify the apparatus in the Declaration of Conformity to allow traceability
  • For self-declared products, update Technical Documentation as specified in Annex II (3)
  • Review the CE label and confirm it’s correctly applied
  • Confirm the operator’s information and technical instructions comply with Article 18.

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