Preparing technical documentation

As a manufacturer, you must:

• prepare technical documentation before placing a product on the market
• ensure the technical documentation is made available to the market surveillance authorities upon request
• keep the technical documentation for 10 years from the date the product is placed on the market (unless explicitly specified otherwise in the relevant legislation)

Technical documentation provides detailed information on the design, manufacture, and operation of a product. It must demonstrate that the product complies with all EU requirements.

Technical documentation is necessary to prove the product meets essential requirements under harmonised EU rules and to justify and support an EU declaration of conformity. You also need this documentation to affix the CE marking  to your product when required.

What to include in your technical documentation

The technical documentation must include an adequate analysis and assessment of the risk(s) and should include at least:

• the manufacturer’s name and address, or those of any authorised representatives
• a brief description of the product
• product identification, e.g. serial number
• the name(s) and address(es) of the facilities involved in the design and manufacture of the product
• the name and address of any notified body involved in assessing the conformity of the product (if applicable)
• 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)
• product label and user instructions

Standards compliance for complex products

If your product falls under multiple EU laws, your technical documentation must:

• clearly indicate which parts or functions of the product are subject to which EU rules
• identify which technical standards (e.g. harmonised EN, ISO, IEC, national standards) have been used for each aspect of compliance
• where non-harmonised standards or in-house methods are used, provide a justification and explain how they demonstrate conformity
• ensure that the documentation structure reflects this mapping clearly, so it can be assessed by market surveillance authorities

Find out more about standards.

Risk assessment

Manufacturers are required to identify and evaluate all potential risks associated with their product. This includes:

• identifying hazards the product may pose to users, property, or the environment
• determining which essential requirements apply (i.e. the basic safety, health, environmental and other requirements protecting certain public interest set out in the relevant EU rules)
• describing the steps taken to eliminate or reduce those risks (e.g. by applying harmonised standards)

This risk analysis must be documented and included in the technical documentation.

Language and format

You may prepare the technical documentation in one of the official EU languages of your choice. However, market surveillance authorities may require a translation of the relevant parts of the documentation into a language which they can understand.

The documentation may be stored in electronic format, provided it remains accessible, well-organised, and available upon request.

As a manufacturer, you should also be able to demonstrate where and how the documentation is stored and maintained beyond the legally required retention period (usually 10 years).