New EMC Directive - What are the changes?

emc-testing The EMC Directive 2004/108/EC is one of a number of CE Marking Directives that are getting a make-over to bring them into line with EU Decision No. 768/2008/EU, in accordance with the New Legislative Framework (NLF) that was introduced in 2008. Subsequently, a NEW recast Electromagnetic Conformity (EMC) 2014/30/EU came into force on the 18^th April 2014, however, the current directive (2004/108/EC) will not be repealed until April 20^th 2016 and until this 2016 date, manufacturers can continue to place products on the market that comply with the current Directive.

OVERVIEW:

The new Directive appears quite different to the Directive it will replace, and the pdf. version has actually doubled in size, but other than rewording, reformatting and reordering the actual changes, the impact on manufacturers is relatively slight; changing to the new Directive should not be too difficult.

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 also now excluded from scope.

OBLIGATIONS:

As with most of the other recast Directives that have been aligned with the NLF, for manufacturers the changes are relatively subtle, with the process being very similar as the current Directive, whilst ensuring that it follows the general principles of Article 30 of Regulation (EC) No 765/2008.

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, the Directive now specifically details the obligations of Authorised 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 jeopardise 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.

Article 14 of the Directive states that the manufacturer may choose to restrict the application of the EU-Type Examination (Annex III) procedure to some aspects of the essential requirements, provided that for the other aspects of the essential requirements the Internal Product Control (Annex II) procedure is applied.

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

TECHNICAL FILE requirements:

It is now stated that the Technical Documentation shall make it possible to assess the apparatus’ conformity with the applicable requirements of this Directive and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall cover, as far as relevant, the design, manufacture and operation of the apparatus. The technical documentation shall include at least the following;

a general description;
conceptual design and manufacturing drawings and schemes of components, sub-assemblies, circuits, etc., and the descriptions and explanations necessary for their understanding;
a list of the harmonised standards applied in full or in part, and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential requirements. Where applied, parts of partly applied harmonised standards should be specified;
results of design calculations made, examinations carried out, etc.;
test reports.

Essential requirements:

The Essential Requirements for Apparatus have not changed (other than replacing the word ‘Protection’ with ‘General’) however, some of the requirements for Fixed Installations are no longer contained in Annex I and are now contained within the body of the Directive.

DECLARATION:

The Declaration of Conformity shall have the model structure set out in Annex IV (a template is now provided), shall contain the elements specified in the modules of Annexes II and III as appropriate, and shall be continuously updated as required. It must also be translated into the language or languages required by the member state in which the apparatus is placed or made available on the market.

The new contents include;

The title is now ‘EU Declaration of Conformity’
The Declaration can be numbered (optional).
It should include: This declaration is issued under the sole responsibility of the manufacturer.
It should state: The object of the declaration is in conformity with the relevant Union harmonisation Legislation.
Suitable identification of the product should be included, sufficient to allow product traceability (there is a suggestion that a colour image of sufficient clarity could be employed).
And, of course, the new Directive number should be employed: 2014/30/EU.

The new EMC Directive 2014/30/EU can be found:

http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32014L0030&from=EN

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New EMC Directive – What are the changes?