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.
Conformity assessment

As a manufacturer, you must carry out a risk analysis and ensure that your
products comply with certain rules before placing them on the EU market.
This procedure is called a conformity assessment and it is carried out during
both the design and production phase. Even if you subcontract the design or
production of your products, it's still your responsibility to ensure that the
conformity assessment is carried out.
The information obtained from the conformity assessment must be included
in the technical documentation.
How to demonstrate compliance with EU rules
You should check if there are any EU rules applicable to your product, if
there are, you must ensure your product complies with them before it can
be traded freely in the EU.
Harmonised standards, where they exist, can help you demonstrate
compliance with EU rules.
What are harmonised standards?
Harmonised standards are developed by recognised European Standards
Organisations: CEN , CENELEC , or ETSI . Following harmonised
standards in the design and manufacture of your products will ensure your
products are in line with corresponding EU rules; this is known
as ‘presumption of conformity'.
Do you have to follow harmonised standards?
No, the use of harmonised standards remains voluntary. You are free to
choose another technical solution to demonstrate compliance with the
mandatory legal requirements.
If you choose not to follow harmonised standards in your assessment, you
can prove compliance by referring to technical specifications such as
national standards, non-harmonised European and international standards,
or your own technical specifications. In these cases, you will have to
provide more details in your technical documentation explaining how your
products comply with legal requirements.
Assessing the conformity of your products
In some cases, you - as a manufacturer - can make a self-assessment of
your product, in other cases, you will need to involve a conformity
assessment organisation (also known as a notified body)  to assist you.
You should check the relevant EU legislation related to the products you
want to assess to see if you need to request assistance.

Conformity assessment organisations

These notified bodies are organisations designated by EU countries to
assess the conformity of certain products before they can be placed on the
market.
You can choose a notified body from the list on the NANDO website  (New
Approach Notified and Designated Organisations).
Doing the conformity assessment yourself
If your product doesn't need to be verified by an independent body, it is up
to you to perform the conformity assessment of your product. This includes
estimating and documenting the possible risks when using your product.
Compiling the technical documentation
Your technical dossier should include all the documents that prove that your
product complies with the technical requirements. Find out how to compile
the technical documentation