Machinery Directive and CE Marking: A Guide for Industrial Manufacturers

What is the Machinery Directive and why is it changing in 2027?

The Machinery Directive 2006/42/CE has been for two decades the standard that establishes the essential health and safety requirements for all machinery placed on the market in the European Economic Area. Any machine — from a hand tool to an automated production line — must meet these requirements and bear the CE marking before being put into service.

From 20 January 2027, the directive will be replaced by Regulation (EU) 2023/1230, adopted in June 2023. Unlike a directive, a regulation is directly applicable in all Member States without the need for national transposition, which eliminates discrepancies between countries.

The main changes in the new regulation respond to the technological evolution of industrial machinery:

• Cybersecurity: connected machines must implement protective measures against unauthorised access and data manipulation
• Software as a safety component: the definition of safety component now explicitly includes software (physical, digital or mixed)
• Artificial intelligence: control systems with machine learning functions require stricter conformity assessments
• Digital documentation: technical documentation may be delivered in digital format (including via QR codes), while maintaining the obligation to provide a paper copy upon request
• Substantial modification: a formal definition is introduced; whoever carries out a substantial modification is considered the manufacturer of the assembly

At MECVIL, as manufacturers of special machinery, we closely follow this regulatory transition because it directly affects every machine we design, manufacture and deliver.

The CE marking process step by step

CE marking is not a label that is placed at the end of a project. It is a process that must be integrated from the design phase:

1. 1.Risk assessment according to ISO 12100: identify the limits of the machine (intended use and reasonably foreseeable misuse), identify hazards and hazardous situations, estimate and evaluate risks. If the risk is unacceptable, apply reduction measures (inherently safe design → guards → information for the user).
2. 2.Application of harmonised standards: there are more than 600 harmonised standards for machinery. Applying them creates a presumption of conformity with the essential requirements of Annex I.
3. 3.Preparation of the technical file: it must include drawings, electrical diagrams, risk analyses, calculations, list of applied standards, instructions for use and test results. It is kept for a minimum of 10 years.
4. 4.Issuing the EU Declaration of Conformity: a document signed by the manufacturer declaring compliance with the applicable directive/regulation, with identification of the machine, applied standards and authorised person.
5. 5.Affixing the CE marking: it is fixed visually, legibly and indelibly on the machine.

For high-risk machines (Annex IV of the directive, Annex I of the new regulation), a notified body must be involved in the conformity assessment.

Do you need advice on CE marking for your machinery?

At MECVIL we integrate the CE conformity process from the engineering phase. Consult with our technical team.

Who is responsible for CE marking?

This is one of the most critical questions in industrial machinery projects, especially when several suppliers are involved:

• The manufacturer of the machine is the one who assumes responsibility for the CE marking and signs the Declaration of Conformity
• When a set of machines is assembled into a complete system, whoever carries out the integration is considered the manufacturer of the assembly and assumes CE responsibility for the system
• In [industrialisation projects for third parties](/en/servicios/industrializacion), CE responsibility must be defined contractually from the outset

In a turnkey project, the integrator who manages all phases — such as MECVIL with its 360° service — naturally assumes CE responsibility for the assembly, as it controls design, manufacturing, assembly and commissioning.

In projects fragmented among multiple suppliers, CE responsibility falls into a grey area. Who signs the Declaration of Conformity when the design comes from one supplier, the structure from another, the wiring from a third and the programming from a fourth? This ambiguity is one of the strongest arguments in favour of the comprehensive manufacturing partner model.

Risk assessment: ISO 12100

Risk assessment according to EN ISO 12100 is the foundation of the entire CE conformity process. It is an iterative process in three phases:

Determining the limits of the machine

The intended use, reasonably foreseeable use, spatial limits (dimensions, reach), temporal limits (useful life, maintenance intervals) and the limits of safety functions are defined.

Hazard identification

All mechanical, electrical, thermal hazards, those produced by noise, vibrations, radiation, processed materials and substances, and those arising from lack of ergonomics are systematically identified. Each hazard is analysed across all phases of the life cycle: transport, installation, normal use, maintenance, cleaning and decommissioning.

Risk estimation and evaluation

For each identified hazard, the severity of the possible harm and the probability of its occurrence are estimated. If the risk is unacceptable, reduction measures are applied following the hierarchy: inherently safe design → guards and protective devices → information for the user (signals, instructions). After applying the measures, the residual risk is reassessed.

At MECVIL, risk assessment is integrated into the design engineering phase, using FEA simulation and 3D CAD design to validate safety decisions before manufacturing.

Implications of the new regulation for machinery manufacturers

Regulation (EU) 2023/1230 introduces changes that directly affect manufacturers who integrate automation, robotics and machine vision systems:

• PLC and safety software: control programmes that execute safety functions (emergency stops, speed limitations, safety barriers) are now formally safety components and must be assessed according to EN ISO 13849 (Performance Level) or EN 62061 (SIL). At MECVIL, our electrical engineering department programmes Siemens, Omron, Panasonic and Mitsubishi PLCs with integrated safety functions.
• Cobots and industrial robots: machines with collaborative robots that work without safety fencing require specific contact risk assessments according to ISO/TS 15066.
• Machine vision with AI: if a machine vision inspection system uses machine learning algorithms to make decisions that affect safety, the system must undergo a stricter conformity assessment, potentially involving a notified body.

How to prepare for the 2027 regulation

If your company manufactures, integrates or modifies industrial machinery, these are the steps to prepare:

1. 1.Review your risk assessments: verify that they cover the new cybersecurity and safety software requirements
2. 2.Identify safety software: any software that executes safety functions must be specifically documented and assessed
3. 3.Update the technical documentation: prepare for digital documentation and verify that it meets the requirements of Annex IV of the new regulation
4. 4.Assess cybersecurity: connected machines need protective measures against unauthorised access
5. 5.Define CE responsibilities: especially in multi-supplier projects, ensure that the Declaration of Conformity is clearly assigned

At MECVIL, we apply lean manufacturing principles to the CE conformity process, integrating it into every phase of the project so that it is not a formality at the end, but a natural part of the machining, assembly and commissioning workflow.

Do you need a manufacturer who integrates CE conformity into the project from the design stage?

At MECVIL we cover the entire cycle: engineering, manufacturing, assembly, safety programming and technical documentation. Contact our team to ensure that your machinery complies with current regulations.