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The Machinery Directive 2006/42/EC sets out the obligations that every manufacturer must meet before placing a machine on the European market. Risk assessment, technical file, instructions for use, CE marking: each step determines compliance and the legal conditions for placing the equipment on the market. LCSI supports industrial manufacturers in building this regulatory documentation, from the initial assessment through to the delivery of final documents.
What is the Machinery Directive 2006/42/EC?
The Machinery Directive 2006/42/EC is a European regulatory text that came into force on 29 December 2009. It harmonises the legislation of Member States on the design and construction of machinery. It also defines the essential health and safety requirements that any equipment placed on the market within the European Union must meet.
Its scope covers:
Machinery and industrial equipment
Interchangeable equipment modifying the function of a machine
Safety components marketed separately
Lifting accessories (chains, cables, slings)
Partly completed machinery, sub-assemblies intended to be incorporated into a complete machine
Certain equipment is excluded from the scope: domestic-use machinery, active implantable medical devices, aircraft, and road transport vehicles. If you are unsure whether the Directive applies to your equipment, LCSI can provide an initial assessment.
The manufacturer's documentary obligations
CE compliance for a machine rests on five documentary obligations that the manufacturer must fulfil before any product is placed on the market. These obligations are cumulative: the absence of a single document is sufficient to invalidate the compliance of the whole.
1. Risk assessment
The risk assessment is the starting point of any compliance process. It identifies the hazards associated with the machine, evaluates the likelihood and severity of the associated risks, and defines the risk-reduction measures implemented. It determines the content of all subsequent regulatory documents.
The method to be applied is defined by harmonised standard EN ISO 12100, which is the European reference for machinery risk assessment.
2. The technical construction file (TCF)
The technical construction file brings together all the elements needed to demonstrate the machine's conformity with the essential requirements of the Directive. It is not systematically submitted to the authorities, but the manufacturer must be able to produce it on demand at any time.
It includes in particular:
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Design drawings and diagrams of the machine
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The list of harmonised standards applied
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The risk assessment report
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Calculations, test results and verification reports
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Declarations of conformity of incorporated components
The TCF must be retained for at least ten years after the manufacture of the last unit of the machine. In the event of a transfer of business or sale, this retention obligation is passed on to the successor.
3. The instructions for use
The instructions for use is the regulatory document provided to the user with each machine. It must be written in the official language or languages of the country or countries of destination of the equipment. Its minimum content is defined by Annex I, section 1.7.4, of the Machinery Directive 2006/42/EC.
Compliant instructions for use must cover:
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The description and identification of the machine (designation, model, serial number)
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The conditions of intended use and reasonably foreseeable misuse
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Specific safety instructions and warnings
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Procedures for commissioning, adjustment and shutdown
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Maintenance and servicing operations and inspection intervals
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Information on noise, vibration and emissions
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Instructions for disposal at end of life
Incomplete instructions, or instructions written in a language not understood by the user, render the manufacturer civilly and criminally liable in the event of an accident. The quality of the writing is just as critical as the regulatory content.
4. The EC declaration of conformity
The EC declaration of conformity is the document by which the manufacturer attests, under their sole responsibility, that the machine meets all applicable essential requirements. It must compulsorily include:
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The full name and address of the manufacturer (or their authorised representative)
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The precise identification of the machine: description, series, type, serial number
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The European directives applied and the harmonised standards used
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The contact details and signature of the manufacturer's authorised representative
This document accompanies the machine when it is placed on the market. It must be retained alongside the technical construction file.
5. CE marking
CE marking is the visible expression of all the preceding steps. It attests that the machine meets the essential requirements of the applicable European directives. It may only be affixed once the technical file has been compiled and the EC declaration of conformity has been signed.
CE marking must comply with precise formal requirements: minimum height of 5 mm, indelible, legible and unobscured characters. Affixing the marking without a complete compliance file constitutes an offence subject to penalties.
Conformity assessment procedure: which route to choose?
The Machinery Directive 2006/42/EC provides for several assessment procedures depending on the nature and risk level of the machine.
01
Internal manufacturing control
For the vast majority of machines, the manufacturer can carry out the conformity assessment themselves without involving a third-party body. They compile the technical file, apply the relevant harmonised standards, and sign the EC declaration of conformity.
02
EC type-examination by a notified body
For machines listed in Annex IV of the Directive, mechanical presses, band saws, portable cartridge-operated fixing tools, platforms for lifting persons, etc, the mandatory involvement of a notified body is required. This body verifies the machine's conformity with the essential requirements before any product is placed on the market.
03
Full quality assurance
Manufacturers with a certified quality management system may use the full quality assurance procedure as an alternative to EC type-examination. This route requires prior certification of the quality system by a notified body.
Machinery Regulation 2023/1230: what will change from 2027
The Machinery Directive 2006/42/EC will be replaced by Regulation (EU) 2023/1230, applicable from 20 January 2027. Unlike a directive, a regulation applies directly in all Member States without national transposition.
The main changes introduced by this new text concern:
The explicit inclusion of connected, autonomous and self-learning machinery
Reinforced cybersecurity requirements for communicating machinery
A revised list of high-risk machinery requiring the involvement of a notified body
Specific rules governing substantial modifications made to machinery already in service
Simplified documentary procedures for small series
Machines placed on the market before 20 January 2027 remain covered by Directive 2006/42/EC. Those placed on the market after that date must comply with Regulation 2023/1230. Anticipating this transition now avoids a complete last-minute documentary overhaul.
What are the risks of non-compliant documentation?
Incomplete or non-compliant documentation exposes the manufacturer to immediate and concrete consequences:
1. Market withdrawal ordered by the supervisory authorities (DGCCRF, DREETS depending on the sector)
2. Civil and criminal liability of the manufacturer in the event of an accident resulting from a documentary failure
3. Legal inability to export to countries that require CE compliance as a customs prerequisite
4. Commercial disputes with distributors or clients who have contractually required CE compliance
5. Loss of business on industrial tenders where documentary compliance is an eliminatory criterion
How LCSI supports manufacturers on documentary compliance
LCSI works with machine manufacturers at every stage of building their regulatory documentation. Our team brings together specialist technical writers, experienced in the requirements of the Machinery Directive 2006/42/EC, Regulation 2023/1230 and the associated harmonised standards (EN ISO 12100, EN ISO 4413, EN 60204-1, etc.).
We provide:
Drafting of compliant instructions for use, in the language of the country of destination
Structuring and updating of the technical construction file
Proofreading, documentary audit and compliance review of existing documents
Support through the documentary transition to Regulation 2023/1230
On-site or remote assignments depending on your project constraints
We work on both one-off projects, a single machine, an urgent regulatory update, and on recurring needs involving ongoing documentary management of a full product range. Our clients operate across a variety of sectors: machine tools, industrial equipment, special-purpose machinery, and consumer goods. They share one common need: reliable, compliant documentation delivered on time.
Frequently asked questions about the Machinery Directive 2006/42/EC
LCSI related services
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