EC declaration of conformity

For products in Class I, the manufacturer must have specified technical documentation on the design of the product showing that it conforms to the essential requirements manufacturing aspects are not covered and a notified body is not involved imless there is a measuring function and/or the product is sterilised. (Annex VII EC declaration of conformity.)... 

The EC Declaration of Conformity procedure (full quality assurance Annex IV), or... 

Annex VI) or the EC Declaration of Conformity (production quality assurance Annex VII). 

All devices other than those covered by Annex II are subject to the EC Declaration of Conformity procedure (Annex III), which does not involve the intervention of a notified body, but which includes supplementary requirements for devices for self-testing, which does involve a notified body (Annex III). 

The EC declaration of conformity must contain the following elements reference to the harmonized standards (see directive for other elements) (93/68/EEC, No L220, p. 21). 

A product must be in compliance with all of the safety directives that apply to it and a manufacturer declares that his product satisfies all the essential requirements of the directives via the EC declaration of conformity (D of C), discussed in Section 11. 

The EC declaration of conformity (D of C) is the manufacturer s statement that he has fulfilled the requirements of all the Community harmonisation legislation relating to his product. The declaration identifies the product or type (for traceability) and all the legislation and standards (in whole or in part) with which conformity is declared. 

The EC declaration of conformity must contain the following elements ... 

Declaration of oonformity the responsible person must then draw up an EC declaration of conformity, described in Annex G, for each machine or safety component supplied. This declaration is intended to be issued with the machine or safety component and... 

Obligations are put on employers to ensure that before lifting equipment is put into use it is thorou y examined for any defects unless the equipment is new, i.e. has not been used before, and it is supported by a valid EC declaration of conformity. V ftth lifting equipment that has to be installed before it can work, the employer must ensure that the safe operation of the equipment is not prejudiced by the manner in which it is installed. This applies particularly to lifting equipment that is moved from one site to another, such as tower cranes. 

After the conclusion of the conformity assessment procedure and of the tests perhaps required, the manufacturer issues an EC-declaration of conformity for his product. He affixes the explosion protection marking (Ex marking) to the product and if the product fulfills the requirements of other applicable European directives he affixes a CE marking to the product as well. 

Before a device can be legally placed on the market in Europe, it must go through an appropriate conformity assessment process to establish that it meets all the essential requirements of the applicable directive. This enables the manufacturer to make a formal declaration of conformity and apply the CE mark of conformity to the device. The manufacturer, or an authorised representative (EC Rep), who takes on the responsibilities imposed by the directives on behalf of the manufacturer, must be established in the EU. 

The requirements for European Community (EC)-type certification are declaration of conformity and technical documentation files for all categories of gloves. For categories II and III, there are additional requirements EC-type examination testing by approved laboratories, certified by approved notified bodies and manufacturing under a formal EC quality assurance system. 

FRRSs must be capable of being opened and closed manually by the fire service in the direction of the approach when positioned across fire fighting routes. Power operated FRRSs must be provided with a Declaration of Conformity and following installation should be CE labelled in accordance with the EC Machinery Directive. Power operated FRRSs also fall within the scope of the Supply of Machinery (Safety) Regulations 1992. Where an FRRS is held in the open position there should be controlled descent when the automatic selfclosing device operates. 

The manufacturer (or his representative) draws up a declaration of conformity and affixes an EC mark to the machinery. Before this can be done, the manufacturer has to document that the machinery meets the requirements in the Machinery Directives. This technical documentation... 

The self-declaration process is that provided by Module A of the Conformity Assessment Procedures of Annex II of Decision 768/2008/EC of 9 July 2008 (EC 2008). Conformity assessment procedures (Modules) cover both design and production phases and shown in Table 1. 

Regulation 11 contains requirements for record-keeping. Any EC conformity declaration received must be kept for as long as the equipment is operated. The reports of thorough examination must be kept as follows ... 

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