Advice on the Machinery Regulation and Machinery Directive
Implementing CE conformity for machinery safely and in compliance with the law
Anyone placing machinery or equipment on the market in the European Union must be able to demonstrate that all applicable safety and health requirements are met. Currently, this conformity assessment is still carried out on the basis of the Machinery Directive 2006/42/EC. From 20 January 2027, it will be replaced by the Machinery Regulation (EU) 2023/1230.
For manufacturers, integrators, and machine builders, this means that CE marking remains a key component of market access. At the same time, the requirements must be correctly classified, technically implemented, and transparently documented.
Cobot Safety supports companies in advising on the Machinery Directive and Machinery Regulation – from the initial classification of the product to the risk assessment, technical documentation and a ready-to-sign EU declaration of conformity.
Machinery Directive today – Machinery Regulation from 2027
Until 19 January 2027, the Machinery Directive 2006/42/EC will continue to apply to machinery. From 20 January 2027, the Machinery Regulation (EU) 2023/1230 will apply directly in all EU Member States.
For practical purposes, it's important to understand that this isn't just a name change. The manufacturer's fundamental responsibility remains. Machines must be designed safely, risks must be assessed, and appropriate protective measures must be implemented. Furthermore, technical documentation, operating instructions, declarations of conformity, and CE marking must be complete and comprehensible.
The new Machinery Directive clarifies and expands certain requirements, for example, regarding digital operating instructions, networked machines, software, AI, cyber safety, and specific machines with increased risk. Therefore, it is advisable to review current and future machinery projects early on to determine whether they still fall under the Machinery Directive or should already be prepared with the Machinery Directive in mind.
What does conformity mean in the context of machinery?
Conformity means that a machine meets all applicable European requirements. This includes not only the mechanical or electrical safety of the machine, but the entire conformity assessment process.
In practice, the following questions, among others, need to be answered:
- Which EU directives and regulations apply to the machine?
- Is it a complete machine, an incomplete machine, or a set of machines?
- Which harmonized standards can be applied to establish conformity?
- Were all phases of the machine's life cycle considered in the risk assessment?
- Are the chosen protective measures sufficient and justifiable from a regulatory perspective?
- Are safety-related control functions correctly assessed and validated?
- Is the technical documentation complete?
- Does the operating manual contain all the necessary information and warnings?
- Is the EU declaration of conformity or declaration of incorporation correctly worded?
- Is a CE marking permitted and required?
Our consulting services will help you to answer these questions in a structured way and to set up the CE process in a legally compliant manner.
Who is responsible for machine conformity?
The responsibility for a machine's conformity generally lies with the manufacturer or the economic operator who places the machine on the market or makes it available under their own name. In practice, however, this responsibility can become complex.
This becomes particularly relevant in the following cases:
- machine manufacturers
- Integrators of robot and automation systems
- Special machine manufacturers
- Companies that modify or substantially alter machinery
- Operators who manufacture or modify machinery for their own use
- Importers and dealers
- Companies that combine several machines into a complete system
- Manufacturers of incomplete machinery
Especially with interconnected systems, retrofit projects, robot cells, or custom-built machines, it is often not immediately clear who is responsible for which tasks. Cobot Safety helps you to clearly define responsibilities and to create the necessary documentation and evidence tailored to each role.
What is required for a machine to be CE compliant?
Signing a declaration of conformity is not sufficient for legally compliant CE marking. The declaration is only the final step in a complete technical assessment and documentation process.
Typically, the following documents and evidence are required for the conformity of a machine:
Description of the machine and its intended use
Machine delineation and definition of interfaces
Determining the applicable guidelines and regulations
Standards research and standards list
Risk assessment across all relevant life phases
Description of risk mitigation measures
Evidence of functional safety, e.g. SISTEMA calculations according to EN ISO 13849-1
Validation and test documentation, e.g. for safety functions, protective devices or overrun times
Operating instructions with safety and warning information
Technical documentation of the machine (circuit diagrams, drawings, etc.)
Our consulting services regarding the Machinery Directive and Machinery Regulation
Our consulting services are aimed at companies that want to place machinery on the market safely, in compliance with standards and legal regulations. We consider not only the formal CE marking, but the entire process leading up to it.
We can assist you with, among other things:
- Classification of whether your product falls under the Machinery Directive or Machinery Regulation
- Clarification of whether a complete machine, an incomplete machine or an assembly of machines is involved.
- Determination of the applicable EU directives and regulations
- Assessment of responsibilities in the CE process
- Conducting or reviewing the risk assessment
- Derivation of suitable risk reduction measures
- Selection and application of harmonized standards
- Evaluation of safety-related control functions
- SISTEMA calculations according to EN ISO 13849-1
- Review of safety concepts and protective devices
- Support with validation and verification
- Creation or review of technical documentation
- Creation or revision of operating instructions
- Drafting of EU declarations of conformity and declarations of incorporation
- Preparation for the requirements of the Machinery Directive from 2027
Consulting for new machines, conversions and retrofit projects
Not only new machines require a thorough conformity assessment. Conversions, modernizations, and retrofit projects can also necessitate a reassessment of the safety and conformity status.
Typical examples include:
- Replacement or modification of the control system
- Integration of a robot
- Retrofitting of protective devices
- Change of operating modes
- Expansion of an existing plant
- Linking of several machines
- Change of intended use
- Software changes affecting machine functions
- Adaptation or extension of safety-related control functions
In such cases, we will assist you in assessing whether a new risk assessment, an adjustment of the documentation, or, if necessary, a new conformity assessment is required.
Why Cobot Safety?
Cobot Safety combines many years of practical experience in mechanical engineering with in-depth expertise in machine safety, robotics, functional safety, and CE conformity. This means you receive not just formal advice, but technically sound support for your specific machine.
Our goal is to process the requirements from the Machinery Directive, Machinery Regulation and harmonized standards in such a way that they become comprehensible and implementable for design, electrical engineering, software, documentation and management.
You will receive clear information on what is required, what evidence is needed, and how the CE process can be documented in a legally compliant manner.
Frequently asked questions about the Cyber Resilience Act:
Is the Machinery Directive currently in effect?
The Machinery Regulation (EU) 2023/1230 has already been published, but will only become mandatory for placing machinery on the market from 20 January 2027. Until 19 January 2027, the Machinery Directive 2006/42/EC remains in force.
As a mechanical engineer, do I still need to familiarize myself with the Machinery Directive?
Yes, especially for machine projects that will only be delivered in 2027 or later, for series production machines, or for long-term development projects. It should be checked early on whether the documentation and the CE marking process already need to be prepared for the Machinery Directive.
What is included in a complete CE conformity assessment?
A complete CE conformity assessment includes, among other things, determining the applicable legal regulations, conducting a risk assessment, implementing appropriate protective measures, applying relevant standards, providing technical documentation, operating instructions, and issuing the EU declaration of conformity.
Who is responsible for CE marking?
The manufacturer or the party who places the machine on the market or makes it available under their own name is generally responsible. In the case of modifications, imports, integrations, or interconnected systems, the specific role of each company must be examined on a case-by-case basis.
Does Cobot Safety also support individual parts of the CE process?
Yes. We provide support for both complete conformity assessment procedures and individual components, such as risk assessment, safety concept, SISTEMA calculation, operating instructions, technical documentation or declaration of conformity.
Can existing CE documentation be reviewed?
Yes. We review existing risk assessments, operating instructions, declarations of conformity, standards lists and technical documentation for plausibility, completeness and legal or normative weaknesses.
Request a consultation on machine conformity now
Do you want to know which requirements from the Machinery Directive or Machinery Regulation apply to your machine? Or do you need support with risk assessment, technical documentation, operating instructions, or EU declaration of conformity?
Cobot Safety guides you safely through the CE process – practical, technically sound and with special expertise in mechanical engineering, robotics and functional safety.
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