Format of a Machinery Directive Technical File
There is no specific format for a Technical File required by the EU or UK Authorities, however it must contain all relevant information, see Contents of a Technical File Page.
Key documents are the Essential Health and Safety Requirement (EHSR) report, Risk Assessment, Functional Safety Validation Report, along with drawings, calculations and test reports showing the equipment complies with the Directive, and any other relevant Directives such as EMC, PED or ATEX.
For ease of reading by relevant authorities, it is suggested that PDF format should be used, as this is likely to continue to be able to be read in the future. The file has to be available for at least ten years, more if it is for series machinery, so needs to be able to be read by Authorities, otherwise they may determine it is insufficient.
It can be in different folders or sections if the file is large. Single PDF files of more than 1,000 pages can be difficult to read, and slow to open.
There is a sample Technical File Index here. Technical File Index. There may be sections that are not applicable, this should be identified.
There are a number of software packages available for compiling Technical Files for the Machinery Directive.
We recommend COMPLIANCE Risk Software. This allows EHSR's to be addressed, Risk Assessment to be carried out and pictures linked to hazards to show the before and after. It will generate a Declaration of Incorporation or Conformity, and allows multiple products to be maintained. A free demonstration can be downloaded and tested before buying.