June 8, 2016
The New Blue Guide of the European Commission Goes into Manufacturer Obligations in Detail
The Blue Guide of the European Commission is the guideline for implementation of all directives and regulations for CE marking. In this revision of the 2000 version, it goes further into the obligations of economic operators in detail and, along with this, into instructions.
The Blue Guide is – as emphasized by the European Commission in the foreword – not legally binding. Nevertheless, it is a significant document on implementing directives according to the New Legislative Framework and provides important reference points for the interpretation of legal terms.
According to the template [Decision No 768/2008] of the New Legislative Framework it is a general obligation of economic operators that products are accompanied by instructions.
Instructions are explicitly named as an example in "4.1 Essential Product Requirements". Under 3, "The Actors in the Product Supply Chain and their Obligations", the following can be read about instructions as a manufacturer obligation:
"…accompany the product with instructions and safety information as required by the applicable Union harmonisation legislation, in a language easily understood by consumers and other end-users, as determined by the Member State concerned. Unless otherwise specified in specific legislation, instructions and safety information need to be provided, whether the product is intended for consumers or other end-users. This should include all the necessary information for the safe use of the product, to enable the consumer to assemble, install, operate, store, maintain, and dispose of the product. Instructions for assembly or installation should include the inventory parts and special skills or tools. Instructions on operation should include information for restriction of use, need for personal protective equipment, maintenance and cleaning or repair. It is for the manufacturer to determine the relevant information which should be included in the instructions and safety information for a particular product. Manufacturers have to look beyond what they consider the intended use of a product and place themselves in the position of the average user of a particular product and envisage in what way they would reasonably consider to use the product. Furthermore, a tool designed and intended to be used by professionals only might also be used by non-professionals, the design and instructions accompanied must take this possibility into account; [...] "
Details are further elaborated upon in numerous footnotes.
The Blue Guide is recommended reading for everyone concerned with CE marking and its requirements. It is available for free download on the European Commission website.