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:
- prepare the technical documentation before placing a product on the market
- ensure the technical documentation is made available to the market surveillance authorities (should they request to see it) as soon as the product is placed on the market
- keep the technical documentation for 10 years from the date the product is placed on the market (unless explicitly specified otherwise)
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:
- your name and address, or those of any authorised representatives
- a brief description of the product
- identification of the product, for example, the product’s 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
- a statement of the conformity assessment procedure that has been followed
- the EU declaration of conformity
- label and instructions of use
- a statement of relevant regulations to which the product complies
- identification of technical standards with which compliance is claimed
- list of parts
- test results
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.
In general the Technical File should include the following information
Technical description and colour photographs of the product
Design documents: schematics, construction drawings, parts lists and certificates
List of standards applied and details of solutions used to comply with the essential requirements
Construction review against harmonised standard
Results of design calculations and assumptions
Test reports
User and installation instructions
Marking and labelling information
Declaration of Conformity
The Technical File must be made available on demand by the national regulatory authorities.
Risk assessment
As a manufacturer, you are responsible for identifying all the possible risks your product could pose and determine the applicable essential requirements. This 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.
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