Declaration of Conformity

Characteristics of the Declaration of Conformity

The Declaration of Conformity must be drawn up by the manufacturer of the machine or his authorized representative in the European Community and must accompany the machine to the user of the same.

The Declaration of Conformity and its translations must have the following characteristics:

it must be written in one or more official languages of the European Community. The manufacturer or his authorised representative shall be responsible for this declaration by affixing the words “Declaration of Conformity” in the official language or languages of the country of use of the machinery,
where there is no Declaration of Conformity in the official language or languages of the country of use of the machinery, the manufacturer or his authorised representative or the person who places the machinery in the language area concerned must provide a translation into the local language. These translations must bear the words “Translation of the original Declaration of Conformity” (in the language of each version produced) and must be accompanied by the original Declaration of Conformity.

This declaration shall only cover the machine in the state in which it was placed on the market, excluding the added components and/or operations subsequently carried out by the end user. In particular, if the manufacturer authorises another economic operator, such as an importer or a distributor, to modify the machine before it has been supplied to the end user, the manufacturer shall remain legally responsible for the machine supplied. The manufacturer is not legally responsible for any additions or changes made to the machine without its permission from other economic operators or the end user. This shall be taken into account when the machinery in use is examined by the market surveillance authorities.

The Declaration of Conformity must be either included in the instruction manual or provided separately. In this case, a document setting out the content of the EC Declaration of Conformity must be included in the instruction manual.

Elements of the Declaration of Conformity

The CE declaration of conformity must contain certain mandatory elements. These include, of course, the name and full address of the manufacturer (or his authorised representative) and must correspond to those marked on the machinery.

If the manufacturer has chosen to appoint an authorised representative in the EU to fulfil all or part of his obligations under Article 5 of the Machinery Directive, the details of the authorised representative must also be indicated in the EC Declaration of Conformity: the name and address of the person authorised to compile the technical file, to be established in the Community.

That person is a natural or legal person established in the EU who has been entrusted by the manufacturer with the task of gathering and making available the relevant elements of the technical file in response to a duly reasoned request from the market surveillance authorities of one of Member States. This ensures a contact point in the EU for non-EU producers.

The person authorised to complete the technical file shall not, as such, be responsible for the design, construction or assessment of conformity of the machinery, for the preparation of the documents included in the technical documentation, the affixing of the CE marking or the drawing up and signing of the EC Declaration of Conformity. These responsibilities remain with the manufacturer.

For manufacturers established in the EU, the person authorised to complete the technical file may be the manufacturer himself, his authorised representative, a person belonging to the manufacturer’s staff (who may be the same signatory to the EC declaration of conformity) or another natural or legal person established in the EU to whom the manufacturer entrusts this task. It is not necessary to create new functions as “EC manager” within companies as there is no obligation regarding the status of this person, provided that he has access and the necessary means to compile the information. However, the responsibility for making the technical file available remains with the company and is not with the person compiling the technical file.

For manufacturers established outside the EU, the person authorised to complete the technical file may be either a natural person or a legal person established in the EU. He shall be responsible for assembling and making available the technical file in response to a duly reasoned request. If a manufacturer established outside the EU has chosen to entrust an authorised representative in the EU with all or part of the obligations set out in Article 5 of the Machinery Directive, the authorised representative in the EU may also be the authorised person at compile the technical file.

The indications required for the description and identification of the machine are substantially identical to those of the marking of the machine. The generic designation of the machine may be in the same language as on the marking, but not necessarily in the same language as the declaration of conformity. However, in the EC declaration of conformity, the details of the machinery must be provided in full. The purpose of this information is to allow both the user and the market surveillance authorities to identify the machine covered by the declaration without ambiguity. As a general rule, the serial number of the machinery covered by the EC Declaration of Conformity must be indicated. In the case of machinery produced in large series, it is possible to draw up a single EC declaration of conformity covering a range of machines produced. This declaration must explicitly include each individual machine (for example by referring to a specific identification number or product code or batch, to a reference that is marked on the machine. In any case, the product range covered by the declaration must be specified and a new EC declaration of conformity must be issued for each new range.

When the machine is subject to other EU directives

in particular where the machinery in question is subject to other EU directives besides the Machinery Directive, the manufacturer may draw up a single CE declaration of conformity for these other directives or regulations, provided that the declaration contains all the information required by each Directive. This is not always possible as some directives specify a particular format for the declaration of conformity.

In particular, the RESS of the Low Voltage Directive (LVD) 2014/35 /EU must be applied to machines. All relevant harmonised standards to the LVD shall also be applied. The LVD procedures for placing on the market and putting into service are not applicable to machinery subject to the Machinery Directive. This means that the Declaration of Conformity for machines subject to the Machinery Directive must not refer to the LVD. It should be recalled that certain categories of low voltage electrical equipment are excluded from the scope of the Machinery Directive. General specifications for the design of electrical equipment of machines are given in EN 60204-1; specifications for high voltage electrical equipment of machines are given in EN 60204-11. Specifications for electrical equipment must also meet the standards required by the specific categories of individual machinery.

Manufacturers may indicate the references of harmonised standards applied in the EC declaration of conformity to inform on the presumption of conformity conferred through the application of harmonised standards covering all essential health and safety requirements (RESS). However, it should be remembered that the application of harmonised standards remains voluntary. Where no harmonised standards have been used, the manufacturer may indicate references to other technical documents used to design and construct the machinery. Please note that the application of such documents does not give a presumption of conformity.

The place of the declaration to be indicated is usually the city where the manufacturer’s premises are located or his authorised representative. Since the CE declaration of conformity must be drawn up before the machinery is placed on the market or put into service, the date of declaration indicated in the EC declaration of conformity must be no later than the date of placing on the market of the machinery or, in the case of machinery for the manufacturer’s own use, no later than the date of putting the machinery into service,

The identity of the person authorised by the manufacturer or his authorised representative to draw up the EC Declaration of Conformity must be indicated next to his signature. The identity of the person shall be understood as including his name, surname and position. The CE declaration of conformity may be signed by the Managing Director of the Company concerned or by another representative of the Company to whom this responsibility has been delegated. The CE declaration of conformity must be signed and retained by the producer or his authorised representative. The signature can be a handwritten signature or a printed digital print. The signature may be reproduced on the copies of the Declaration of Conformity accompanying the machinery.

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