A technical file provides a technical justification for your claim to conformity on which your CE marking is based. NPS can help you compile a Technical File that will meet the requirements of any client or enforcement officer. The process of compiling a Technical File also provides a structured way of assessing conformity. NPShas a great deal of experience in making risk assessments and compiling checklists against harmonised standards, Essential Health and Safety Requirements.
A technical file is the Technical Justification for the claim to CE conformity. Different Directives have different requirements for Technical File content, but fundamental content is:-
A technical description of the equipment including mechanical drawings and schematics.
Copies of user instructions.
Test reports
Checklists against essential requirements of Directives
Checklists against requirements of standards.
It is not mandatory for a manufacturer to hold a Technical File at all times, but without actually going through the process required to compile a Technical File, it is hard to decide whether your equipment is actually in conformity.
The only persons who have a right to demand a copy of a Technical File are enforcement authorities such as HSE inspectors or customs officials. They may request a copy of the Technical File fi they have any doubts about the conformity of some equipment.
Purchasers of equipment have no legal right to demand that a copy of a technical file is provided to them, but many larger purchasers have started to include a contractual requirement that a copy of a Technical File is provided to them as an assurance.