EU Machinery Regulation and CE marking: who signs what

What changes on 20 January 2027

The EU Machinery Regulation, Regulation (EU) 2023/1230, replaces the Machinery Directive 2006/42/EC. It applies from 20 January 2027. Machinery placed on the EU market before that date can continue under the directive, but a machine placed on the market after the date needs to meet the regulation.

The change is more than a rename. The regulation uses a legal text rather than a directive, so it applies directly in member states without a national transposition step. It also updates the essential health and safety requirements, gives more attention to digital and autonomous functions, and sets out duties for software and digital instructions. The conformity assessment framework remains familiar, but the evidence has to match the new requirements.

For a buyer, the important question is not whether the supplier has heard of the regulation. It is whether the supplier can show which version of the standard, which risk assessment and which declaration apply to the machine or component being supplied. A certificate dated before the change may still be relevant, but it does not answer the question by itself.

Who is responsible for what

The manufacturer of the machine carries the main duty. That is the business that designs and builds the machine, or has it built under its name. It carries out the risk assessment, prepares the technical documentation, follows the applicable conformity assessment procedure, draws up the EU declaration of conformity and applies the CE marking.

An importer established in the EU has a verification role. It must check that the manufacturer has carried out the conformity assessment, that the technical documentation exists, that the marking and identification are present, and that the instructions and declaration are supplied. A distributor must act with due care and must not make a machine available if it knows, or should know, that it does not comply.

A component supplier sits in a different position. A bracket, heat sink, busbar, coil or enclosure supplied to a machine builder is usually not a machine in its own right. It does not get a CE mark as machinery unless it is a safety component placed on the market separately. The component still has to meet the requirements the machine builder specifies, and the builder may need the component's drawings, material data and test results to complete the machine file.

The technical file is the centre of the case

The technical documentation has to show how the machine meets the essential health and safety requirements. In practice it contains the general description, the drawings, the circuit diagrams, the risk assessment, the list of standards applied, the test reports, the instructions and the declaration. For a series machine, it also needs to show how variants are covered.

The file should be assembled before the declaration is signed, not after a customer asks for it. A common failure is a folder of drawings with no link to the risk assessment. Another is a declaration that lists a standard which the design does not actually follow. A third is a file that describes the prototype while the production machine has different guards, different software or a different motor.

Risk assessment and standards

The risk assessment identifies the hazards, estimates the risk, sets out the protective measures and records the residual risk. It should cover the whole life of the machine: transport, installation, commissioning, use, cleaning, maintenance and dismantling. It should also cover reasonably foreseeable misuse, not only the intended operation.

Harmonised standards give a presumption of conformity when they are applied correctly and cover the relevant requirements. They are not a checklist that can be copied from a previous project. The designer has to confirm that the standard applies to the machine type, the version is current, and the design follows the clauses claimed. Where no harmonised standard covers a hazard, the file needs another reasoned route to conformity.

The regulation gives more weight to digital and autonomous behaviour. A machine that makes decisions, moves without a fixed guard or receives software updates needs the related risks assessed. The safety function may depend on software, sensors and communication. That makes the component data more important: response times, failure modes, EMC behaviour and the conditions under which a sensor was tested.

The conformity route and the CE mark

Most machinery can follow an internal production control procedure, where the manufacturer carries out the assessment and prepares the file without a notified body. Some categories listed in the regulation require a notified body, for example certain machinery with particular hazards or safety components. The manufacturer has to select the correct route before the design is frozen.

The EU declaration of conformity identifies the machine, the manufacturer, the applicable legislation and the standards used. It is signed by the person authorised to bind the manufacturer. The CE mark is then applied to the machine, normally on the machine itself and in the instructions. The mark is not a quality mark and it is not issued by the EU. It is the manufacturer's statement that the legal duties have been met.

For a component supplier, the useful output is not a CE certificate for a bracket. It is a clear statement of the requirements the component meets, the tests performed, the limits of use and the changes that would require the machine builder to reassess. That package lets the builder integrate the part without guessing.

What to ask a component supplier

Start with the intended function. State whether the part is structural, insulating, current carrying, guarding or part of a safety function. A supplier cannot assess the consequences of a change without knowing which function the part performs. The same aluminium bracket may be decorative on one machine and load bearing on another.

Ask for the drawing revision, material certificate, surface finish record, dimensional report and any functional test. For a safety related part, ask for the failure mode, the design calculation and the change notification process. If the part includes software or a sensor, ask for the version and the conditions used in the test.

Put change control in the contract. A new material, a new plating, a new subcontractor or a changed tolerance can affect the machine file. The supplier should notify before the change, not after the shipment. The buyer should have a route to reject a change that would trigger a new risk assessment.

• Function of the part and the consequences of failure
• Drawing revision, material grade and finish specification
• Dimensional, functional and material test records
• Declarations for RoHS, REACH and other applicable rules
• Change notification and revalidation terms
• Software or sensor version, if the part includes either

A practical timeline before January 2027

For machines placed on the market from 20 January 2027, work backwards from the launch date. Confirm the product category and the conformity route. Update the risk assessment against the new essential requirements. Check that the standards listed are current and applicable. Revise the technical file and the instructions. Then arrange the declaration and the marking.

Allow time for the supply chain to respond. A new guard may need a new mould or a new sheet metal part. A software change may need a new validation cycle. A notified body route can add weeks or months. The businesses that leave the work until the last quarter will be competing for the same test slots and the same specialist advice.