A guide into stress-free product compliance

The Declaration of Conformity (DOC)

Disclaimer: This document provides guidance and is not a legally binding interpretation and shall therefore not be relied upon as legal advice.

What is Declaration of Conformity (DoC)?

Several Compliance Clips mention the EU Declaration of Conformity (also referred to as: 'EU-DoC or DoC'). But what is it? This clip will explain the basic information on the Declaration of Conformity.

The DoC is the declaration that the product complies with all relevant requirements of the applicable EU legislation and in which the (legal) responsibility is assumed. The manufacturer, or his authorised representative established within EU, must draw up and sign a DoC as part of the conformity assessment procedure provided for in the harmonisation legislation. The legislation further imposes the obligation to draw up and sign the DoC, before placing a product on the EU market. 

Preparation is everything!

Before you can start drafting a DoC for a product, you must know to which EU legislation your product must comply. The documentation that supports a claim that a product is compliant is called a 'technical file.' You cannot draft a DoC if the technical file is not complete (the DoC would also not be complete).

We advise you to gather all necessary information early in the manufacturing or buying process. Tip: Your ProductIP technical file contains a list of all legislation your product must comply to.
When the product falls within the scope of certain legislation, CE-marking is also obliged. A list of all CE-marking legislation can be found here.
Compliance clip 622 informs about CE-marking.

Content of the DoC

The DoC may take the form of a document, a label or equivalent. It must contain sufficient information to enable all products covered by it, to be traced back to it.

The DoC must contain at least the following information:
General requirements

  • all relevant information to identify the applicable harmonisation legislation;
  • the manufacturer;
  • the authorised representative;
  • the notified body, if applicable;
  • the product;
  • where appropriate a reference to harmonised standards or other technical specifications.

Legislative specific requirements
There is also specific legislation that defines specific information to be added to the DoC. For example, the Toys directive requires a picture of the product in the DoC, and the Noise directive requires the sound power level to be indicated.

Multiple legislation applicable?

We are often asked if several DoC's must be drafted if more than one law applies to the product (for example: the Toys directive + EMC directive). The answer is that a single DoC is required whenever a product is covered by several pieces of Union harmonisation legisla­tion requiring a DoC.

The DoC and the corresponding technical file must in general be kept for 10 years. However there is also legislation requiring a period between 5 and 15 years from the date of placing the product on the market.

The ProductIP DoC Generator

ProductIP supports you in drafting an EU DoC with the 'CE Declaration' application in 22 languages.
Your technical file contains all information to be included in the DoC.
In addition, in early 2020 it will be possible to generate a Mutual Recognition Declaration (MRD) through the ProductIP-system (see Compliance clip 620).

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