EU technical documentation and the declaration of conformity: contents and how long to keep them

Your Europe's page on preparing technical documentation says a manufacturer must prepare technical documentation before placing a product on the market, and keep it for 10 years from the date the product is placed on the market, unless explicitly specified otherwise in the relevant legislation. Your Europe's page on signing an EU declaration of conformity says a copy of the most recent declaration must be kept for 10 years after the product is placed on the EU market. That page does not carry the same "unless explicitly specified otherwise" wording, and other sources set out different conditions, so the period is worth reading per legislation rather than assuming.

Technical documentation: what it contains

The Your Europe page on preparing technical documentation describes the file as detailed information on the design, manufacture, and operation of a product, and says it must demonstrate that the product complies with all EU requirements. That page states the documentation must include an adequate analysis and assessment of the risk(s) and should include at least:

• a brief description of the product
• product identification, e.g. serial number
• the manufacturer's name and address, or those of any authorised representatives
• the name(s) and address(es) of the facilities involved in the design and manufacture of the product
• product label and user instructions
• the conformity assessment procedure followed
• identification and analysis of applicable EU rules, including a description of which essential requirements are relevant
• identification of technical standards used to demonstrate compliance (e.g. EN, ISO, IEC)
• a risk assessment and an explanation of how identified risks are addressed (e.g. through design or standards)
• a list of critical components and materials that affect evidence of compliance with applicable standards (e.g. test reports)
• the name and address of any notified body involved in assessing the conformity of the product (if applicable)

Alongside the contents, the same page frames one of the manufacturer's duties as ensuring the technical documentation is made available to the market surveillance authorities upon request.

The same page carries a caution about standards: one of the most important rules of product legislation is that the use of harmonised standards is voluntary, but they give a "presumption of conformity" with the law.

On language and storage, that page says you may prepare the technical documentation in one of the official EU languages of your choice, and that market surveillance authorities may require a translation of the relevant parts of the documentation into a language which they can understand. It also says the documentation may be stored in electronic format, provided it remains accessible, well-organised, and available upon request.

The declaration of conformity: what it contains

Your Europe's page on signing an EU declaration of conformity calls the DoC a mandatory legal document that you as a manufacturer, or your authorised representative, must sign to declare that your products comply with all EU requirements. That page also says the DoC is signed only after you have complied with the legal requirements for your product, that is, undertaken the relevant conformity assessment and compiled all the supporting technical documentation.

The contents on that page are:

• your name and full business address or that of your authorised representative
• the product's serial number, model or type identification
• means of identification of product allowing traceability, which can include an image
• a statement, stating you take full responsibility
• the relevant legislation with which the product complies, as well as any harmonised standards or other means used to prove compliance
• the details of the notified body which carried out the conformity assessment procedure (if applicable)
• your name and signature
• the date the declaration was issued

Your Europe also states that the declaration must include the signatory's name, position, signature, and the date of issue, and that you must translate the EU declaration of conformity into the language or languages required by the EU country in which your product is sold.

On availability, the page says the DoC must be made available to national market surveillance authorities upon request, although some EU product rules require that the DoC accompany the product, for example radio equipment.

The Blue Guide 2022 (2022/C 247/01) states that the EU Declaration of Conformity must contain all relevant information to identify the Union harmonisation legislation according to which it is issued, as well as the manufacturer, the authorised representative, the notified body if applicable, the product, and where appropriate a reference to harmonised standards or other technical specifications. The same document states that a single declaration of conformity is required whenever a product is covered by several pieces of Union harmonisation legislation requiring an EU Declaration of Conformity.

Decision No 768/2008/EC, in Annex III, gives a model declaration whose headings include:

• Name and address of the manufacturer or his authorised representative:
• This declaration of conformity is issued under the sole responsibility of the manufacturer (or installer):
• References to the relevant harmonised standards used or references to the specifications in relation to which conformity is declared:

Your Europe also says the DoC must be reviewed and updated to reflect any changes, including:

• product modifications, for example design, components, materials
• updates to applicable EU legislation or harmonised standards
• changes to contact details of the manufacturer or authorised representative
• switches in conformity assessment bodies or procedures

How long to keep them

Source	Document	Period and condition
Your Europe, preparing technical documentation	Technical documentation	Keep for 10 years from the date the product is placed on the market (unless explicitly specified otherwise in the relevant legislation)
Your Europe, signing an EU declaration of conformity	Copy of the most recent declaration of conformity	Keep for 10 years after the product is placed on the EU market
Blue Guide 2022	Technical documentation	Keep for 10 years from the date of placing the product on the market, unless the applicable Union harmonisation legislation expressly provides for any other duration
Blue Guide 2022	EU Declaration of Conformity	Keep for ten years from the date of placing the product on the market, unless the legislation provides for any other duration
Blue Guide 2022, manufacturer duty	Technical documentation and the EU Declaration of Conformity	Keep for 10 years after the product has been placed on the market, or for the period specified in the relevant Union harmonisation act
Blue Guide 2022, importer duty	Copy of the EU Declaration of Conformity	Keep for 10 years after the product has been placed on the market, or for the period specified in the relevant Union harmonisation act
Regulation (EU) 2023/988, Article 9(3)	Technical documentation (manufacturer)	Keep for a period of 10 years after the product has been placed on the market, and make available to market surveillance authorities upon request
Regulation (EU) 2023/988, Article 11(6)	Copy of technical documentation referred to in Article 9(2) (importer)	Keep for a period of 10 years after the importer has placed the product on the market

The Regulation (EU) 2023/988 texts are quoted here as published in the Official Journal, not from a consolidated version. Article 52 provides that it shall apply from 13 December 2024.

The Blue Guide 2022 also states that for imported products, the importer must take on this responsibility for the Declaration of Conformity.

Who is responsible

Your Europe's page on signing an EU declaration of conformity says manufacturers are legally responsible for ensuring their product meets all EU requirements and for issuing the declaration of conformity, regardless of whether they are based inside or outside the EU. The same page warns that the legal obligation for the DoC lies with the party placing the finished product on the market under their own name or brand.

Decision No 768/2008/EC puts the duties in similar terms. Article R2(2) states that manufacturers shall draw up the required technical documentation and carry out the conformity assessment procedure applicable or have it carried out, and that where compliance of a product with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EC declaration of conformity and affix the conformity marking. Article R10(3) states that by drawing up the EC declaration of conformity, the manufacturer shall assume responsibility for the compliance of the product.

Sources

• Preparing technical documentation, European Union (Your Europe)
• Signing an EU declaration of conformity, European Union (Your Europe)
• The 'Blue Guide' on the implementation of EU product rules 2022, European Commission
• DECISION No 768/2008/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, European Parliament and Council (EUR-Lex)
• REGULATION (EU) 2023/988 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, European Parliament and Council (EUR-Lex)

Checked 11 October 2026.

This page is an unofficial summary and is not affiliated with the European Commission or any EU body; the official text governs.