EU Declaration of Conformity (DoC)

The importance of the document

Manufacturers have to make sure that their products comply with all applicable legislation.
Once they have done this, they create and sign a document called an EU Declaration of Conformity (DoC) to underwrite that their product satisfies all applicable EU legislation.
By signing the EU DoC, the manufacturer takes full responsibility for the compliance of the product.
This obligation for manufacturers applies to all products that require a CE marking.

Sharing the EU DoC

EU harmonisation legislation may require that the product is accompanied by a copy of the EU Declaration of Conformity.

The obligation to accompany the product with a copy of the EU DoC is stated in the following legislation: Machinery Directive 2006/42/EC, Machinery Regulation (EU) 2023/1230, Radio Equipment Directive 2014/53/EU, Personal Protective Equipment Regulation (EU) 2016/425, Gas Appliances Regulation (EU) 2016/426, Measuring Instruments Directive 2014/32/EU, Outdoor Noise Directive 2000/14/EC, and ATEX Directive 2014/34/EU.

In some cases a simplified EU DoC is allowed, that shall contain the exact internet address where the full text of the EU DoC can be obtained.

This obligation is highlighted in ProductIP's technical file requirements list.

The date matters

The date on the DoC is important because it shows that all the steps have been carried out in the right order: product conformity was demonstrated before the product was first placed on the (EU) market.

Manufacturers shall draw up an EU DoC after the compliance of a product with the applicable requirements has been demonstrated. The earliest possible date is when all the tests were successfully completed.

The latest possible date on the DoC is the same or earlier as the market release date. This is because the product has to be designed and produced according to all requirements before it can be placed on the market.

The market release date is the reference date in your ProductIP file because it determines the applicable requirements.
The date on the DoC should logically fit into the period of production, testing and sales. The further away the date on the DoC is from the market release date, the more likely the market surveillance authorities may consider the DoC to be incomplete or incorrect!

The template

The generic template of the (EU) Declaration of Conformity is given in Annex III of Decision 768/2008/EC.
Additional information to be mentioned on the DoC may be required by product specific legislation, this can be found in the related directive or regulation. A non-exhaustive overview is given below.

Notified Bodies

Many directives and regulations have conformity assessment procedures (‘modules’) that require the involvement of one or more Notified Bodies.  An overview of possible modules can be found in this article on ProductIPedia.

If a Notified Body is involved then additional information shall be added to the DoC about:

• Name, address and identification number of the Notified Body;
• Details on the performed activities: conformity assessment procedure module, description of ‘intervention’;
• Identification, number, date and validity of the certificate(s) issued.

Medical Devices

Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices require additional information on the DoC about:

• The Basic UDI-DI (Unique Device Identifier);
• The Single Registration Number (SRN) - a unique number issued by the competent authority to an organisation (manufacturer, authorised representative or importer) that requires registration in the European Database on Medical Devices (EUDAMED). Optional until May 2024;
• The intended purpose - the use for which the medical device is intended according to the manufacturer;
• The Risk class of the medical device, classified in accordance with the rules.

Outdoor Noise

Directive 2000/14/EC about the noise emission in the environment by certain equipment for use outdoors requires that the measured sound power level and the guaranteed sound power level for the products are mentioned on the DoC.
The noise levels shall be rounded to integers (whole numbers) and expressed in dB (decibel).

Pyrotechnics

Directive 2013/29/EU for pyrotechnical articles, such as fireworks or airbags, requires a registration number for traceability purposes. The  registration number is assigned by the Notified Body carrying out the conformity assessment.
The registration numbers shall be on the product label and on the DoC.

Additional information

In a few cases additional information shall be added to the DoC:

• Directive 2014/53/EU on radio equipment (wireless products) requires where applicable, “a description of accessories and components, including software, which allow the radio equipment to operate as intended and covered by the EU declaration of conformity”;
• Regulation (EU) 2016/426 on gas appliances requires in the case of fittings, “instructions on how the fitting should be incorporated into an appliance or assembled to constitute an appliance in order to assist compliance with the essential requirements applicable to finished appliances”;
• Directive 2013/53/EU on recreational craft and personal watercraft requires a statement of the propulsion engine.

And there is more

Regulation (EC) 1935/2004 requires that food contact materials are accompanied by a written Declaration of Compliance stating that the materials comply with the applicable rules. Annex IV of Regulation (EU) 10/2011 provides information about the information that is required for the declaration of compliance of plastic food contact materials.

Regulation (EU) 305/2011 on construction products requires CE marking if a harmonised standard exists. But instead of a DoC, the construction products regulation requires a Declaration of Performance (DoP). It could be that other “CE” legislation is also applicable, in that a DoC is required in combination with the DoP. Its successor, Construction Products Regulation (EU) 2024/3110 requires a 'Declaration of Performance and Conformity' per 8 January 2026.

The new Packaging and Packaging Waste Regulation (PPWR) (EU) 2025/40 introduced the obligation to draw up an EU Declaration of Conformity for each packaging (but no CE marking) from 12 August 2026.

And the new Batteries and Waste Batteries Regulation (BWBR) (EU) 2023/1542 demands CE marking and an EU Declaration of Declaration in addition to many more requirements that will enter into force in stages (ProductIPedia: battery deadlines).

Your file in ProductIP

Each technical file in ProductIP lists the applicable legislation and standards for the product in question. 
Whenever the product requires an EU DoC, the requirements overview will show the “EU DoC’ tool.
The tool will guide users through the necessary steps to generate an EU Declaration of Conformity.

The EU Declaration of Conformity is part of the technical documentation that in most cases shall remain available for 10 years after the last product has been sold.

Authorities may request the EU Declaration of Conformity as part of the technical documentation.