The Technical File is the collection of documents that demonstrate the machine’s compliance with the Essential Safety Requirements (ESR) .
This documents allows the market surveillance appointed authorities to easily checl the conformity of the machinery considered.
The responsibility for preparing the technical file lies with the manufacturer of the machine.
If the machine is imported from a country outside the EU—where the manufacturer is not required to prepare the technical file—this responsibility falls tothe importer or the authorized representative.
It must be drafted in one or more languages of the European Community and must be made available to the competent authorities of the member states for at least 10 years following its publication or drafting.
DOCUMENTATION IN THE TECHNICAL FILE
As defined in Annex VII of the Machinery Directive 2006/42/EC, the Technical File consists of the following documents:
- General Description of the Machine
- overall design of the machine, control circuit diagrams, as well as the related descriptions and explanations necessary to understand how the machine operates
- detailed and complete drawings, accompanied, where applicable, by calculation notes, test results, and certificates; this information must make it possible to verify the machine’s compliance with the essential health and safety requirements,
- documentation related to the risk assessment that must demonstrate the procedure followed, including:
- List of Essential Safety and Health Requirements Applicable to the Machine
- protective measures implemented to eliminate identified hazards or to reduce risks; if necessary, an indication of any residual risks associated with the machine
- standards and other technical specifications applied that specify the essential health and safety requirements covered by those standards,
- any technical report providing the results of tests conducted by the manufacturer itself or by a body selected by the manufacturer or its authorized representative,
- a copy of the machine’s instructions,
- if applicable, the declaration of incorporation for the included partly completed machinery and the related assembly instructions,
- if applicable, a copy of the EC Declaration of Conformity for the machinery or other products incorporated into the machinery,
- a copy of the EC Declaration of Conformity.
