The Technical File is the documentary heart of CE marking for machinery: without it you can't demonstrate compliance with the Machinery Directive 2006/42/EC. In this guide we look at what it is, what it must contain (Annex VII) and how to draft it in an organized way.
What Is the Machinery Technical File?
The Technical File is the set of documents the manufacturer (or their representative) must draft and keep to demonstrate that the machine meets the essential safety requirements (ESR) of the Machinery Directive. It is not handed to the customer: it stays with the manufacturer and must be made available to the competent authorities on request. Its structure is set out in Annex VII of the directive.
What Must the Technical File Contain (Annex VII)?
According to Annex VII of Directive 2006/42/EC, the Technical File must contain at least:
- A general description of the machine
- Construction drawings and diagrams (assembly, circuits, etc.) together with the necessary descriptions and explanations
- Documents relating to the risk assessment (risk analysis, measures adopted, residual risk)
- The technical standards and specifications used
- Results of the calculations, technical checks and tests carried out
- Documentation attesting compliance with the Essential Safety Requirements (Annex I)
- The instructions manual
- For series-produced machinery: documentation on production and quality controls; for safety components (Annex V): documentation on the components and their characteristics
- A copy of the EC Declaration of Conformity
If a notified body was involved, the File must also include the required certificates and reports.
How to Draft the Technical File: Order and Tools
Drafting a Technical File by hand (just folders and Word/PDF files) is possible but risky: versions get lost, and inconsistencies build up between the risk assessment, manual and EC Declaration. The most efficient solution is to use CE marking software that guides you through completion (an Annex VII checklist), centralizes the documents and automatically generates the EC Declaration and manual from the same data. This way the File stays consistent and up to date. For the full process: How to CE Mark a Machine.
Reesly ProTip
With Reesly you complete the Technical File following a guided workflow: risk assessment, construction documents, Annex V, manual and EC Declaration in a single place. Discover the features and request a demo.
Retention and Obligations
The manufacturer (or their representative) must keep the Technical File for at least 10 years from the date the last machine of the series (or the single unit) was built. It must be kept within the European Union and made available to national authorities in paper or electronic format, in a language they accept (often the language of the Member State).
The Technical File and Annex V (Safety Components)
For the safety components listed in Annex V (e.g. protective devices, two-hand controls), the machine's manufacturer must include in the Technical File the suppliers' certificates and declarations, as well as the characteristics needed for safe integration. Software that manages an Annex V library and links certificates to projects makes this obligation much easier.
Frequently Asked Questions About the Technical File
What is the machinery Technical File?
It's the set of documents that demonstrate the machine's compliance with the essential safety requirements of the Machinery Directive. It is defined in Annex VII and kept by the manufacturer, not handed to the customer.
What must the Technical File contain?
A description of the machine, drawings and diagrams, the risk assessment, standards used, results of calculations and tests, ESR documentation, the manual, a copy of the EC Declaration, documentation on safety components (Annex V) and, where applicable, notified body certificates.
How long must the Technical File be kept?
At least 10 years from the date the last machine of the series (or the unit) was built. It must be kept within the EU and made available to authorities on request.
Also read: EC Declaration of Conformity, How to CE Mark a Machine, Machinery Directive Regulation.