This guide helps manufacturers and integrators identify the questions to resolve before choosing standards, commissioning tests or appointing a machinery specialist.
Which machinery legislation applies?
As of 27 September 2026, Directive 2006/42/EC remains the principal EU machinery framework for products within its scope. The main application date of Regulation (EU) 2023/1230 is 20 January 2027; some provisions have separate dates. The European Commission's machinery guidance explains the change.
Establish the product's legal category, intended use and planned placing-on-the-market or putting-into-service event. Check the applicable transitional provisions. Do not select the legal regime using the order date, design-start date or the newest standard's publication date alone.
Other product rules may also apply, depending on the machine and its functions. Identify relevant interactions and exclusions rather than adding every possible directive to the declaration.
Legal requirements and standards have different roles
Under the Machinery Directive, the manufacturer or authorised representative must ensure that a risk assessment is carried out and that the machinery is designed and constructed with its results in mind. The applicable essential health and safety requirements are legal requirements. EN ISO 12100 provides a recognised framework for organising risk assessment and risk reduction; that does not make the purchase or use of this one document universally mandatory.
The Directive provides a presumption of conformity for the essential requirements covered by an applicable harmonised standard whose reference has been published in the Official Journal. That presumption is limited to the requirements covered. It is not a blanket guarantee of safety or compliance with every law. See Article 7 and Annex I of Directive 2006/42/EC.
For a project under the new Regulation, check the references and conditions applicable to that Regulation. A citation under the Directive should not simply be treated as a citation under the Regulation.
A standards selection starting point
The following families illustrate different engineering tasks. They are not an exhaustive list or a statement that any particular edition is currently cited for your project. Check the exact EN adoption, amendments, scope and official reference before selection.
| Reference family | Planning use | Question to resolve |
|---|---|---|
| EN ISO 12100 | General approach to machinery risk assessment and risk reduction. | What hazards arise over the machine's lifecycle, and how will the chosen measures be verified? |
| EN 60204-1 | Electrical equipment of machines. | Does the equipment fall within the selected edition's scope, and what inspection and test evidence is needed? |
| EN ISO 13849-1 | Safety-related parts of control systems. | Which safety functions are required, what performance is needed and how will the design be assessed and validated? |
| EN ISO 14120 | Design and construction of fixed and movable guards. | Which guarding measures suit the hazards, foreseeable access and operating conditions? |
| Machine-specific standards | Requirements for a particular machine type or application. | Is there a more specific standard whose scope matches the complete machine and intended use? |
The ISO catalogue describes ISO 12100's risk-assessment and risk-reduction scope. International catalogue status is one input; it does not confirm the status of the corresponding European harmonised reference.
For the other publication scopes, consult the official records for IEC 60204-1, ISO 13849-1 and ISO 14120, then check the relevant European adoption and citation separately.
Check the cited edition before relying on it
Use the Commission's machinery standards page to locate the relevant implementing decisions and amendments. Check restrictions, the requirements covered, replacement references and dates when a reference ceases to give its legal effect.
The Commission's consolidated summary is a useful navigation aid; the page explains that the summary itself has no legal effect. Keep a record of the actual decision and reference used. Do not label a list “current harmonised standards” merely because its documents are the newest catalogue editions.
Build an evidence plan before commissioning work
- Define the machine: boundaries, intended use, users, operating modes, environment and interfaces.
- Assess risk: identify hazards, evaluate risks and document the protective measures.
- Map requirements: connect legal requirements to standards or other technical solutions and the evidence needed.
- Agree verification: define calculations, inspections, tests, safety-function assessment and validation appropriate to the design.
- Prepare documentation: compile the technical file, instructions, required declaration and marking information for the applicable regime.
- Manage changes: review whether modifications affect the evidence, assessment route or legal responsibilities.
This is a planning sequence. It must be adapted to the machine and the applicable assessment procedure.
Does every machine need a notified body?
No. For machinery under Directive 2006/42/EC, Article 12 sets out the procedures, with different conditions for machinery listed in Annex IV. The correct route depends on the product and the relevant conditions. Do not treat every industrial machine as requiring third-party certification, or every use of harmonised standards as sufficient for an internal assessment route.
Check the procedure under the legislation that will apply to the project. Where a notified body is required, verify its designation and scope through the register linked from the Commission's machinery page.
Partly completed machinery, existing equipment and modifications
Partly completed machinery has a distinct procedure. Under the Directive this includes relevant technical documentation, assembly instructions and a declaration of incorporation. It is not given CE marking under the Machinery Directive as if it were a completed machine. Other applicable legislation must still be considered. See Article 13 and Annexes II, VI and VII.
The publication of a new standard does not by itself require every existing machine to be re-marked. Continued-use duties and the consequences of modifications depend on the circumstances and applicable rules. The Commission explains that sufficiently extensive changes can make equipment effectively new machinery. A modification project therefore needs a specific assessment; “all upgrades require re-certification” is not an adequate rule.
Request the right machinery support
Prepare the machine description, intended markets, expected supply or commissioning date, drawings, known hazards, existing assessments and the question you need resolved. State whether you need risk-assessment support, electrical testing, control-system verification, documentation review or assessment by a designated body.
Prepare a test request · Explore laboratory support · Browse product-compliance providers
Confirm the provider's relevant legal entity, technical scope and availability before appointment. European Standards is an independent information and introductions platform; it does not approve machinery or perform the manufacturer's conformity assessment.
General planning guidance. Official sources checked on 27 September 2026. Confirm project-specific obligations and current references before relying on them.