Guidelines on the application of Directive 2006/95/EC - V. Conformity Assessment Procedures under the "Low Voltage" Directive

What are the conformity assessment procedures to be applied?

20. Article 8 and Annex IV of the Directive describe the procedure by which the manufacturer or his authorised representative established in the Community [22] ensures and declares conformity of the electrical equipment with the provisions of the Directive. This includes three main elements:

Technical documentation

Before a product is placed on the market the manufacturer puts together the technical documentation which makes it possible to assess whether the electrical equipment complies with the requirements of the Directive (see below)[23].

Declaration of conformity

The manufacturer or his authorised representative established in the Community are also required, and are the only ones authorised to do so, to draw up in writing a declaration of conformity (see below) before placing the product on the market.

CE marking

Before it is placed on the market the electrical equipment must have the "CE" marking affixed. Only the manufacturer or his authorised representative established in the Community are authorised to affix the "CE" marking.

Whilst the importer is not able to declare conformity to the Directive, he/she needs to act with due care to ensure that clearly non-compliant products are not placed onto the market. [24]

21. Where no standards within the meaning of the Directive have been applied, the manufacturer has to provide within the technical documentation a description of the solutions adopted to satisfy the safety requirements of the Directive.

In case of challenge by the authorities in charge of market surveillance, a report in the sense of Article 8(2) (which however is not obligatory) is considered an element of proof. In fact, in addition to the three basic conformity assessment measures, mentioned above, Article 8(2) provides, in the event that conformity is challenged, for the possible submission to the market surveillance authority of a report drawn up by a notified body as evidence that the electrical equipment complies with the safety objectives (Article 2 and Annex I).

The main function of article 8.2 is to provide the conditions most favourable to progress and dynamism in the Electrotechnical industry. It thus facilitates the marketing of high-tech electrical equipment which, being such, cannot benefit from the support of any technical standards since often such standards are drawn up after the development of a technical innovation.

What must be included in the technical documentation?

22. It must include details of the design, manufacture and operation of the electrical equipment in so far as these details are needed to assess the conformity of the electrical equipment with the requirements of the Directive.

Accordingly, it contains:

Who must keep the technical documentation and where?

23. The manufacturer or his authorised representative established in the Community must keep this documentation at the disposal of the national authorities for inspection purposes for at least ten years from the last date of manufacture of the product. The technical documentation may be kept on electronic support, provided that it is easily accessible for inspection. Where the manufacturer is not established in the Community and he has no authorised representative in the Community, this obligation is incumbent upon the importer or the person responsible for placing the product on the Community market.

This technical documentation must be held within the Community in such a way it can be presented to the authorities upon first request and within a reasonable time-frame (e.g. two weeks).

Where must the CE marking be affixed?

24. The CE marking is placed by the manufacturer, or his authorised representative established in the Community, on the electrical equipment or, where this is not practically possible, on the packaging, the instructions for use or the guarantee.

What is the meaning of, and are the requirements of the CE marking?

25. The CE marking declares conformity of an electrical equipment with the essential requirements and conformity assessment procedures set out under the "Low Voltage" Directive and all the other directives applicable to it.

The CE marking must be affixed visibly, legibly and indelibly.

The affixing of markings which are likely to deceive third parties as to the meaning and form of the CE marking is prohibited.

Who must keep the declaration of conformity and where?

26. The manufacturer, or his authorised representative established in the Community, or, when the manufacturer is not established in the Community and has no authorised representative in the Community, the importer or person responsible for placing the product on the market, must keep a copy of the declaration of conformity at the disposal of the national authorities for inspection purposes, in the same way as the technical documentation. Thus the national market surveillance authorities may, if appropriate, require a copy of the declaration of conformity.

What must be included in the declaration of conformity?

27. Annex III.B of the Directive describes the content of the declaration of conformity as follows [25]:

The declaration of conformity must be drawn up at least in one of the official languages of the Community.

A number of questions have been raised on the issue of the Declaration and the need to show compliance to the latest Directive.

It was further accepted, that from the date on which Directive 2006/95/EC came into force (i.e. 16th January 2007), all newly issued documents, especially Declarations of Conformity and Technical Files, where references are made, should refer to this Directive.

However, there is no need to update existing documents, as long as no other corrections are necessary.

[22] These obligations do not extend to an importer who will, in general, not have a detailed knowledge of which directives have been considered or technical specifications applied.

[23] Annex IV of the "Low Voltage" Directive states that the manufacturer must take all measures necessary in order that the manufacturing process ensures compliance of the products with the technical documentation and the requirements of the Directive.

[24] With regard to electrical consumer products, cf. also the obligations of "distributors" under Article 5(2) and (3) of the General Product Safety Directive (GPSD) 2001/95/EC. The relationship between the LVD and the GPSD is discussed in Section VI below.

[25] See also EN 45014 containing an example of a declaration of conformity.