The EU Machinery Directive, formally Directive 2006/42/EC, is the safety law that any machinery must comply with before it can be sold or put into service in the European Economic Area. It sets the essential health and safety requirements for design, defines who must do what to prove compliance, and controls the use of the CE marking on machinery. It replaced Directive 98/37/EC on December 29, 2009,1European Agency for Safety and Health at Work. Directive 2006/42/EC – Machinery Directive and it will itself be replaced by Regulation (EU) 2023/1230 on January 20, 2027.2EUR-Lex. Regulation (EU) 2023/1230 of the European Parliament and of the Council Until then, this directive is the rulebook.
What Counts as Machinery
The directive defines machinery as an assembly of linked parts or components with at least one moving part, driven by an energy source other than direct human or animal effort.3European Commission. Machinery That single definition pulls in factory robots, powered conveyors, presses, saws, and most industrial equipment. Alongside complete machines, the directive covers interchangeable equipment that changes a machine’s function after it is put into service, safety components sold separately (light curtains, pressure-sensitive mats), lifting accessories such as slings and chains, removable mechanical transmission devices, and partly completed machinery.1European Agency for Safety and Health at Work. Directive 2006/42/EC – Machinery Directive
Article 1(2) excludes products already regulated elsewhere. The exclusions that trip up manufacturers most often are household appliances, audio and video equipment, IT equipment, and office machinery that fall under the Low Voltage Directive (2014/35/EU);4European Commission. Low Voltage Directive (LVD) motor vehicles and trailers with their own type-approval regime; transport by air, water, and rail; weapons including firearms; specially designed military and police equipment; fairground and amusement park equipment; and nuclear machinery.5EUR-Lex. Directive 2006/42/EC of the European Parliament and of the Council One nuance is worth keeping in mind: machinery mounted on an excluded vehicle (a crane on a truck, equipment installed on a ship) remains within scope even when the vehicle itself is not.
Essential Health and Safety Requirements
Annex I sets out the mandatory health and safety requirements a machine must satisfy before it goes on the market. The organizing principle is safety integration: hazards are addressed at the design stage rather than covered by warning labels afterward. Compliance begins with a risk assessment. You identify the machine’s intended use and any reasonably foreseeable misuse, map every potential hazard, and evaluate the severity and likelihood of harm. The hazards to consider include mechanical risks such as crushing and shearing, electrical risks, thermal hazards, noise, vibration, radiation, and risks from the materials the machine processes or emits.
The Risk-Reduction Hierarchy
Annex I requires manufacturers to reduce identified risks in a fixed order, matching the methodology in EN ISO 12100:6International Organization for Standardization. ISO 12100:2010 – Safety of Machinery – General Principles for Design – Risk Assessment and Risk Reduction
- Eliminate the hazard through design. Change the geometry, materials, or operating principle so the hazard does not exist.
- Add protective measures when the hazard cannot be designed out: guards, interlocks, emergency stops, safeguards that prevent access or stop the machine if someone enters the danger zone.
- Provide information for use for any residual risk that survives the first two steps: signs, signals, and detailed instructions.
The order is not a menu. A manufacturer cannot go straight to warning labels because engineering a guard is expensive. Market surveillance authorities will review the risk assessment and check whether higher-priority measures were genuinely considered before lower-priority ones were relied on.
The Technical File and Declaration of Conformity
Two documents carry the compliance case. The technical file, defined in Annex VII, contains everything needed to demonstrate the machine meets the essential requirements: general arrangement drawings, electrical and hydraulic circuit diagrams, the full risk assessment, test results, a list of the essential requirements that apply, the harmonized standards used, and a description of the methods used to eliminate or reduce the hazards identified.5EUR-Lex. Directive 2006/42/EC of the European Parliament and of the Council The file does not ship with the machine, but it must be produced within a reasonable time on request from a national authority, and it must be kept for at least 10 years after the last unit is manufactured.
The EC Declaration of Conformity, defined in Annex II, is the manufacturer’s legally binding statement that the machine meets all applicable directive requirements.1European Agency for Safety and Health at Work. Directive 2006/42/EC – Machinery Directive It carries the manufacturer’s name and full address, the identity of the person authorized to compile the technical file (who must be established in the EEA), the machinery’s description and identification including model and serial number, a statement of conformity, and the harmonized standards or technical specifications applied. Someone with authority to bind the company signs it.
Conformity Assessment: Self-Certification or Notified Body
For most machinery, the manufacturer performs the conformity assessment internally. You carry out the risk assessment, build the technical file, confirm the machine meets the essential requirements, issue the Declaration of Conformity, and apply the CE marking. No external body reviews the design.
Annex IV lists high-risk categories where a design error is especially likely to cause serious injury. These include circular saws and band saws for wood or meat, hand-fed surface planers, injection and compression molding machines with manual loading, presses for cold-working metals, portable chainsaws, vehicle servicing lifts, underground mining locomotives, manually loaded refuse trucks with compression mechanisms, guards for removable transmission devices, and logic units performing safety functions, among others.5EUR-Lex. Directive 2006/42/EC of the European Parliament and of the Council
If your Annex IV machine was designed entirely in accordance with harmonized standards that cover all relevant essential requirements, you can still self-certify. Otherwise, you must involve a Notified Body through one of two routes: EC type-examination under Annex IX, where the Notified Body reviews the technical file and tests a representative sample; or full quality assurance under Annex X, where the Notified Body audits and approves your quality system.
The CE Marking
The CE marking is the visible sign that the machine has passed a conformity assessment and meets all applicable EU safety legislation. The letters “CE” appear in the prescribed proportional format at a minimum height of 5 millimeters, placed on the machine itself near the manufacturer’s name or trademark, using the same technique as the identification plate.7Your Europe. CE Marking – Obtaining the Certificate, EU Requirements
The marking is not a quality mark or a certification of product performance. It is a legal declaration that the product complies with every EU directive that applies to it, which for a typical machine will include others alongside the Machinery Directive, such as the directive on electromagnetic compatibility. Applying the marking without genuine compliance, or leaving it off when it is required, are both enforcement violations.
Instructions and Language
Every machine must ship with instructions in the official language or languages of the member state where it is placed on the market or put into service. Annex I, Section 1.7.4 requires the instructions to be labeled either “Original instructions” (where the manufacturer wrote them in that language) or “Translation of the original instructions,” and a translation must be accompanied by the original-language version. The manufacturer is responsible for the accuracy of the translations even when a distributor or importer arranges them. Maintenance instructions intended for specialized technicians appointed by the manufacturer may be supplied in a single EU language those technicians understand.
Partly Completed Machinery
If you make a motor-driven gearbox intended to be built into a larger machine, or a similar assembly that cannot function on its own, the compliance route is different. Instead of an EC Declaration of Conformity, you issue a Declaration of Incorporation stating which essential health and safety requirements were applied and fulfilled, along with a clear statement that the equipment must not be put into service until the final machinery it is built into has been declared compliant.8Health and Safety Executive for Northern Ireland. Declaration of Incorporation Assembly instructions must ship with the unit and become part of the technical file of the final machinery. The 10-year retention rule for technical documentation still applies.5EUR-Lex. Directive 2006/42/EC of the European Parliament and of the Council
Selling into the EU from Outside
Manufacturers based outside the EU can sell machinery into the European market, but the compliance chain must include someone physically established in the EEA. Under Regulation (EU) 2019/1020 on market surveillance, every product within scope must have an economic operator in the EU who can respond to authority requests. In practice this is either an authorized representative appointed by the manufacturer, or an importer established in the EU.
An authorized representative can hold copies of the technical file and Declaration of Conformity, produce documentation for national authorities, cooperate on corrective actions, and sign the Declaration of Conformity on the manufacturer’s behalf. Appointing a representative does not shift liability. The manufacturer remains fully responsible for the safety of the product and the accuracy of the conformity assessment.
Enforcement
The directive itself does not specify fines or criminal penalties. Article 23 requires each member state to establish its own enforcement rules, mandating only that penalties be “effective, proportionate and dissuasive.”5EUR-Lex. Directive 2006/42/EC of the European Parliament and of the Council Penalties therefore vary across the EU: some states impose administrative fines, others pursue criminal prosecution for serious cases, and market surveillance authorities can order products withdrawn from sale or recalled.
In practice, the enforcement action manufacturers meet is a market surveillance inspection. Authorities can demand the technical file, verify the Declaration of Conformity, check the CE marking, and test the machine against the harmonized standards you declared. Failing to produce the technical file within a reasonable time is itself a violation, which is why the 10-year retention rule matters.
What Changes on January 20, 2027
Regulation (EU) 2023/1230, published on June 14, 2023, replaces Directive 2006/42/EC starting January 20, 2027.2EUR-Lex. Regulation (EU) 2023/1230 of the European Parliament and of the Council After that date, CE marking of machinery and the treatment of partly completed machinery follow the new rules. Products placed on the market before January 20, 2027 under the current directive remain lawfully on the market, but new products, and machines that undergo substantial modification, must comply with the regulation.
Several changes matter for planning:
- It is a regulation rather than a directive, so it applies directly and uniformly across all member states without national transposition, removing some of the current interpretive variation between countries.
- Instructions for use may be provided in digital format, as long as users can easily access and understand them.9European Agency for Safety and Health at Work. Regulation 2023/1230/EU – Machinery
- Safety components with self-evolving behavior using machine learning, and machinery with embedded AI systems that ensure safety functions, are placed in the high-risk Annex I, Part A and require Notified Body involvement regardless of whether harmonized standards were applied.
- Substantial modifications, physical or software, that create a new hazard or increase an existing risk to the point that significant new protective measures are needed, trigger a new conformity assessment performed by the person who made the modification.
If you are designing machinery in 2026 that will still be produced in 2027, compare your existing risk assessments and technical files against the regulation’s requirements now rather than closer to the switchover.