On the 5th April 2016, the European Commission published an updated version of “The Blue Guide on the Implementation of EU Product Rules”. The document, commonly referred to as the “Blue Guide”, sets out guidelines on introducing products to the EU market. It serves as a reference point for the implementation of all the CE marking directives and regulations. The new version of Blue Guide replaces the 2000 edition.
Key topics & changes
The Blue Guide explains how the EU regulates the free movement of goods. Some of the key points covered by the guide include:
- actors in the product supply chain and their legal obligations
- product requirements
- conformity assessment
- market surveillance
The 2016 version includes both revised and brand new chapters. The new ones concern, among other things, the obligations of manufacturers and other actors as well as the application of legislation for online sales. The 2016 edition also sets out new guidance on the update and translation of the Declaration of Conformity and on the format of instructions for use.
One of the key actors in the supply chain, as listed in the Blue Guide, is the Authorized Representative. The Authorized Representative is a legal representative required for all non-European manufacturers placing goods on the EU market. Its main role consists of providing a registered address in the EU, serving as a vigilance contact point, completing EU notification, national registration and representing the manufacturer towards the competent authorities.
Blue Guide available on Obelis website
The entire text of the 2016 edition of Blue Guide is now available on the Obelis website in the CE Marking Legislation section. If you wish to know more about the guide and the legal requirements for introducing goods into the European market, do not hesitate to contact us.