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Declaration of Conformity

Ferry Vermeulen Law & Legislation

According to the CE marking directives, every manufacturer or duly authorized representative of the manufacturer, based in any country within the European Economic Area (EEA), is obligated to draw up a Declaration of Conformity. This is in compliance with the conformity assessment procedure. This declaration must be issued prior to the placement of products on the market in Europe.

What Is A Declaration Of Conformity?

In summary, the EU Declaration of Conformity can be defined as a document, wherein a manufacturer formally declares the compliance of a particular product with the essential health and safety requirements of the relevant product safety directives. With the drawing up and the signing of the EU Declaration of Conformity, the said manufacturer takes full responsibility for the product’s compliance with applicable laws.

The Declaration of Conformity is deemed a very important legal document. Provided that there are no noticeable or known flaws with the product, with the declaration drawn up properly, and with CE markings displayed on the product, suppliers and end users will assume that the product conforms with the directives mentioned on the Declaration of Conformity.

In addition, CE marked products, accompanied by a Declaration of Conformity are considered as complying with the requirements of the directives by market surveillance authorities, unless there is evidence to the contrary.

The authenticity of a Declaration of Conformity is determined by who the issuer is. When properly issued, it will be issued by the manufacturer of the product, the importer or the distributor. Never by a Notified Body or a test house.

The signature on the document should be of the person with authority to make decisions on behalf of the manufacturer, or of the manufacturer himself of course. So the signature should come from the manufacturer or his authorized representative. This is especially, in regard to committing the necessary means by which the CE marking procedure can be finalized. Thus, in essence, the signatory should also be the person to be held accountable for any invalidity regarding CE compliance.

In the case of products falling under more than one directive, a single Declaration will be issued declaring conformity to more than one directive. Alternatively, there may be more than one Declaration for each directive product falls under.

In cases where a CE marked product falls under a different incorporated product, as in a lock in a machine, the Declaration for the main product may only declare the conformity of the main product. Thus, the Declarations for the CE marked parts of the main product should be included in a technical file for the main product.

Contents of The Declaration Of Conformity

Though the basic features of a Declaration are common through-out the board, the requirements on the content of the declaration of conformity can differ slightly per directive.

The following is required by most of the directives:

  • Name and full business address of the manufacturer or the representative authorized to issue the Declaration;
  • An identification number of some sort. This number could easily refer to the serial number, product number, model or type.
  • A Declaration statement, stating that the Declaration is issued under the manufacturer.
  • The name, address and identification number of the Notified Body which carried out the conformity assessment procedure;
  • The relevant legislation complied with; standards used, with dates and amendments specified.
  • Identity and signature of an authorized person
  • The date the Declaration was issued;

The Declaration of Conformity should be drawn up in one of the official languages of the EU. However, member states of the EU might require the Declaration to be translated.

When to Provide A Declaration Of Conformity

 The Declaration of Conformity should be part of the technical file and made available upon request of market authorities. Only in some cases it should be provided with the product.

Templates for the Declaration Of Conformity

Templates of Declaration of Conformity’s for each individual directive can be downloaded below. Have a look at (http://instrktiv.com/en/declaration-of-conformity/) if you want to know more about how to draw up your own DoC.