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How to create a Declaration of Conformity

When creating a declaration of conformity document there is certain information that must be included as a minimum the information required can be found in the relevant directive. CE marked products all require the manufacturer to have available a declaration of conformity even in cases where a Doc is not required to be supplied with the product. As a general rule the DoC need only be a single page. For certain directives the declaration of conformity needs to form part of the user manual. Electronic versions of a declaration of conformity PDF, or other formats are useful as this will allow a manufacturer to send the document electronically should anyone require a copy.

The DoC must contain the following information

Machinery Directive 2006/42/EC

1. Business name and full address of the manufacturer and, where appropriate, his authorised representative;
2. name and address of the person authorised to compile the technical file, who must be established in the Community;
3. description and identification of the machinery, including generic denomination, function, model, type, serial number and commercial name;
4. a sentence expressly declaring that the machinery fulfils all the relevant provisions of this Directive and where appropriate, a similar sentence declaring the conformity with other Directives and/or relevant provisions with which the machinery complies. These references must be those of the texts published in the Official Journal of the European Union;
5. where appropriate, the name, address and identification number of the notified body which carried out the EC type-examination referred to in Annex IX and the number of the EC type-examination certificate;
6. where appropriate, the name, address and identification number of the notified body which approved the full quality assurance system referred to in Annex X;
7. where appropriate, a reference to the harmonised standards used, as referred to in Article 7(2);
8. where appropriate, the reference to other technical standards and specifications used;
9. the place and date of the declaration;
10. the identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or his authorised representative.

Partly completed machinery

1. business name and full address of the manufacturer of the partly completed machinery and, where appropriate, his authorised representative;
2. name and address of the person authorised to compile the relevant technical documentation, who must be established in the Community;
3. description and identification of the partly completed machinery including generic denomination, function, model, type, serial number and commercial name;
4. a sentence declaring which essential requirements of this Directive are applied and fulfilled and that the relevant technical documentation is compiled in accordance with part B of Annex VII, and, where appropriate, a sentence declaring the conformity of the partly completed machinery with other relevant Directives. These references must be those of the texts published in the Official Journal of the European Union;
5. an undertaking to transmit, in response to a reasoned request by the national authorities, relevant information on the partly completed machinery. This shall include the method of transmission and shall be without prejudice to the intellectual property rights of the manufacturer of the partly completed machinery;
6. a statement that the partly completed machinery must not be put into service until the final machinery into which it is to be incorporated has been declared in conformity with the provisions of this Directive, where appropriate;
7. the place and date of the declaration;
8. the identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer or his authorised representative. 1. business name and full address of the manufacturer and, where appropriate, his authorised representative;

Radio Equipment Directive 2014/53/EU

1. Radio equipment (product, type, batch or serial number):
2. Name and address of the manufacturer or his authorised representative:
3. This declaration of conformity is issued under the sole responsibility of the manufacturer.
4. Object of the declaration (identification of the radio equipment allowing traceability; it may include a colour image of sufficient clarity where necessary for the identification of the radio equipment):
5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation: Directive 2014/53/EU Other Union harmonisation legislation where applicable
6. References to the relevant harmonised standards used or references to the other technical specifications in relation to which conformity is declared. References must be listed with their identification number and version and, where applicable, date of issue:
7. Where applicable, the notified body … (name, number) … performed … (description of intervention) … and issued the EU-type examination certificate: …
8. Where applicable, description of accessories and components, including software, which allow the radio equipment to operate as intended and covered by the EU declaration of conformity:
9. Additional information:
Signed for and on behalf of: …
(place and date of issue):
(name, function) (signature)

Electromagnetic Compatibility Directive 2014/30/EU (EMC Directive 2014/30/EU)

1. Apparatus model/Product (product, type, batch or serial number):
2. Name and address of the manufacturer or his authorised representative:
3. This declaration of conformity is issued under the sole responsibility of the manufacturer.
4. Object of the declaration (identification of apparatus allowing traceability; it may include a colour image of sufficient clarity where necessary for the identification of the apparatus):
5. The object of the declaration described above is in conformity with the relevant Union harmonisation legislation:
6. References to the relevant harmonised standards used, including the date of the standard, or references to the other technical specifications, including the date of the specification, in relation to which conformity is declared:
7. Where applicable, the notified body … (name, number) performed … (description of intervention) and issued the certificate:
8. Additional information:
Signed for and on behalf of:
(place and date of issue):
(name, function) (signature)

Toys Directive 2009/48/EC

1. No … (unique identification of the toy(s))
2. Name and address of the manufacturer or his authorised representative:
3. This declaration of conformity is issued under the sole responsibility of the manufacturer:
4. Object of the declaration (identification of toy allowing traceability). It shall include a colour image of sufficient clarity
to enable the identification of the toy.
5. The object of the declaration described in point 4 is in conformity with the relevant Community harmonisation
legislation:
6. References to the relevant harmonised standards used, or references to the specifications in relation to which
conformity is declared:
7. Where applicable: the notified body … (name, number) … performed … (description of intervention) … and issued
the certificate:
8. Additional information:
Signed for and on behalf of:
(place and date of issue)
(name, function)(signature)

Noise Directive 2000/14/EC

1. name and address of the manufacturer or his authorised representative established in the Community
2. name and address of the person who keeps the technical documentation
3. description of the equipment
4. conformity assessment procedure followed, and, where appropriate, name and address of the notified body involved
5. measured sound power level on an equipment representative for this type
6. guaranteed sound power level for this equipment
7. a reference to this Directive
8. the declaration that the equipment conforms to the requirements of this Directive
9. where appropriate, the declaration(s) of conformity and references of the other Community Directives applied
10. the place and date of the declaration
11. particulars of the signatory authorised to sign the legally binding declaration for the manufacturer or his authorised representative established in the Community.

The information to be included varies slightly by directive so the directive itself should be checked to ensure that all mandatory information is included in any declaration.

Example of a Declaration of Conformity:

Declaration of Conformity Example

CEM International Ltd. will supply upon request a declaration of conformity template to any existing customer.

Contact us to see how we can help.
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