Life and travel
Last checked: 14/08/2020

Technical documentation and EU declaration of conformity

Coronavirus, medical supplies and protective equipment

The technical documentation provides information on the design, manufacture, and operation of a product and must contain all the details necessary to demonstrate the product conforms to the applicable requirements.

If you are the manufacturer, there are certain rules that must be followed when placing a product on the market; you must:

The technical documentation is necessary to prove the product meets the essential requirements and therefore justify and support an EU declaration of conformity. You need this documentation in order to affix the CE marking to the product.

How to draw up the technical documentation?

The technical documentation should include at least:

As a manufacturer, you should be able to demonstrate where and how the various parts of the document are held and maintained.

You can usually choose in which language you want to prepare the technical documentation. However, the market surveillance authorities may ask you to translate the technical documentation depending on the EU country where the product has been placed on the market. If requested, you can also provide it in electronic format.

Risk assessment

As a manufacturer, you are responsible for identifying all the possible risks your product could pose and determine the applicable essential requirementsThis analysis must be included in the technical documentation. In addition, you will need to explain the ways in which you have addressed the risks identified to ensure that your product complies with the applicable requirements, for example, by applying harmonised standards.

EU declaration of conformity

An EU declaration of conformity (DoC) is a mandatory document that you as a manufacturer or your authorised representative need to sign to declare that your products comply with the EU requirements. By signing the DoC you take full responsibility for your product's compliance with the applicable EU law.

How to draw up a declaration of conformity

As a manufacturer, it is your responsibility to draw up the EU declaration of conformity(DoC). It should contain the following information:

For imported products, the importer must ensure that the product is accompanied by the DoC and must keep a copy of it for 10 years after the product has been placed on the market.

You must translate the EU declaration of conformity into the language or languages required by the EU country in which your product is sold.

EU legislation

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