Technical Files

SafeMech can help you compile a CE marking Technical File to support the CE marking on your machinery.

CE marking Technical FileA Technical File is a collection of documentation describing how a product meets the requirements of the Directives relevant to it.

The individual Directives broadly specify what needs to go into a technical file. The contents vary between Directives but typical content would be:-

  • A description of the equipment including drawings and circuit diagrams
  • A checklist against the Essential Requirements of the relevant Directive
  • A checklist against the requirements of relevant standards
  • Calculations and test reports
  • Copy of User instructions

SafeMech has a lot of experience of compiling Technical Files. We have templates for the Technical File itself and documents that it should contain. Because of this experience, we can normally compile a Technical File much faster than a manufacturer's own staff.

In particular we can quickly create risk assessments and an Essential Health and Safety Requirements (EHSR) checklist for Machinery Directive 2006/42/EC Technical Files.

Once we have complied one Technical File, in many cases, it can be used by the manufacturer's own staff as a template for the creation of others for other equipment in the manufacturer's product range. 

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Frequently Asked Questions

Q. Must I have a Technical File prepared for all my products?
A. The legal requirement is that you must be able to compile a Technical File within a reasonable time if EU enforcement authorities demand it. In practice, most of the work of compiling a technical file is already done by the process of checking that your product is in conformity. 

Q. Can customers demand to see a copy of the Technical File?
A. Customers do not have a right to demand a copy of a Technical File, but if you don't understand what a Technical File is and cannot even supply basic components like a Risk assessment, the customer may suspect that you do not really understand the CE marking process and your technical compliance may be as bad as your documentary compliance.

Q. Do I need to make a separate Technical File for every product with a CE marking?
A. No. One Technical file can cover a  range of products and you could have a "framework" Technical File which could be adapted to a specific product on demand.

 

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Tel  0151 336 7754
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