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.
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 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.
The EU DoC is not a marketing document!
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.
- 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.
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).
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.
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.
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.
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) No 10/2011 provides information about the information that is required for the declaration of compliance of plastic food contact materials.
A new Packaging and Waste Regulation is expected to come into force in 2023. This will introduce a conformity declaration for each packaging. Not CE but similar.
A new Battery Regulation is also expected to come into force in 2023. Batteries will be placed under a CE “regime”. This means that there an EU DoC will be required for batteries and or that products incorporating batteries need an updated conformity assessment resulting in a new EU DoC that then also shall mention the Battery Regulation (and if applicable by then also the Packaging Regulation - even without CE this needs to merge onto the EU DoC in case a product has CE).
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.