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.
We have the Technical and Compliance Personnel who can advise you on how to draw up a technical documentation.
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.
Although we are not a consultancy, we can advise on Technical & Compliance issues, we can also recommend Consultancy Firms who have been vetted by our team.
Copyright © 2025 - All rights reserved. Made with 💖 by Irish Steel
