Directive 2006/42/EC Explained: Scope, CE Marking, and 2027 Transition

Directive 2006/42/EC is the European Union law that sets the safety rules for machinery placed on the market or put into service in the EU and the wider European Economic Area. To sell a covered machine legally, a manufacturer must run a risk assessment against the essential health and safety requirements in Annex I, follow the conformity assessment route that fits the product, compile a technical file, sign an EC Declaration of Conformity, provide user instructions, and affix the CE marking. The directive applies from initial design through end use, and it stays in force until Regulation (EU) 2023/1230 replaces it on 20 January 2027.¹

What Counts as Machinery

Articles 1 and 2 define “machinery” broadly. If a product has linked parts, at least one of which moves, and it runs on something other than direct human or animal effort, it falls within scope.² The directive also covers interchangeable equipment attached to a machine after it is put into service, safety components sold separately whose failure could endanger people, lifting accessories such as slings and chains, and removable mechanical transmission devices that carry power between self-propelled machinery or a tractor and another machine.³

Article 1(2) excludes a long list of products handled by other EU legislation: motor vehicles and their trailers, agricultural and forestry tractors, air, water, and rail transport, household appliances, ordinary IT and office equipment, seagoing vessels, weapons, fairground rides, and nuclear-specific machinery, among others.⁴ One trap catches manufacturers regularly: a machine mounted on an excluded vehicle stays in scope. A crane bolted onto a truck must comply with the directive even though the truck itself does not.

Partly Completed Machinery

An assembly that is almost a finished machine but cannot perform a specific application on its own, such as a drive system, is treated as partly completed machinery under Article 2(g).⁴ The compliance path is different. The manufacturer issues a Declaration of Incorporation stating which essential requirements are already met, does not affix a CE mark under the Machinery Directive, and supplies assembly instructions detailed enough for whoever integrates the equipment to understand the safety-related interfaces. Other directives, such as the EMC Directive, may still require CE marking of their own.

The Six Steps to Legal Placement on the Market

Article 5 sets out what has to be done before a machine can be sold or put into service in the EU. All six steps must be complete:

Satisfy the essential health and safety requirements in Annex I.
Make the technical file available.
Provide instructions for use.
Complete the applicable conformity assessment procedure.
Draw up the EC Declaration of Conformity so that it travels with the machine.
Affix the CE marking.⁴

Essential Health and Safety Requirements

Annex I lists the mandatory design and construction requirements every covered machine must satisfy.⁵ The starting point is a risk assessment covering every hazard the machine could present across its foreseeable life: transport, assembly, use, maintenance, and disposal.

The directive then imposes a strict three-step hierarchy that must be followed in order. Design out the risk first, so the machine’s inherent construction is as safe as possible. Where design cannot eliminate a risk, add protective measures such as guards, interlocks, or light curtains. Only then, for hazards that survive the first two steps, inform users through warnings on the machine, instructions, and where necessary recommendations for protective equipment and training.⁴

The order matters. Slapping a warning label on an exposed blade instead of fitting a guard does not comply, no matter how clear the label. Warnings are a last resort. Annex I also covers control systems, stability, electrical supply, ergonomics, lighting, and emissions.

Harmonised Standards and Presumption of Conformity

The directive states goals rather than exact technical solutions. Those solutions live in harmonised European standards, usually prefixed EN or EN ISO, whose references are published in the Official Journal of the European Union. A machine designed in line with a relevant harmonised standard is presumed to meet the essential requirements that standard covers.⁶

Using harmonised standards is voluntary. A manufacturer can choose an alternative technical solution, but without the presumption of conformity the burden shifts: the design must be independently proven to meet every applicable requirement. Following the published standards is generally the easiest path, and it becomes especially important for high-risk categories on the Annex IV list.

Conformity Assessment Routes

Article 12 lays out how a manufacturer demonstrates compliance. The route depends on two things: whether the machine appears on the Annex IV list of high-risk categories, and whether it was built to harmonised standards.²

Machinery Not on Annex IV

Most machinery falls outside Annex IV. For these products the manufacturer performs an internal assessment under Annex VIII, sometimes called self-certification. No third party is involved. The manufacturer runs the risk assessment, verifies compliance with the essential requirements, compiles the technical file, and signs the Declaration of Conformity.

High-Risk Machinery on Annex IV

Annex IV identifies categories treated as especially hazardous: circular saws, woodworking planers, presses, injection or compression moulding machines for plastics and rubber, certain types of lifting equipment, and vehicle servicing lifts, among others. The route then depends on standards:

If the machine is built fully to harmonised standards that cover all applicable safety requirements, the manufacturer may still self-certify under Annex VIII, or opt for EC type-examination by a Notified Body (Annex IX followed by Annex VIII internal checks), or use the full quality assurance procedure under Annex X.
If the standards were not followed, only partly applied, or none exist, self-certification is unavailable. The manufacturer must submit to EC type-examination by a Notified Body or use the full quality assurance procedure.²

In an EC type-examination, the Notified Body reviews the technical documentation, inspects a representative specimen of the machine, and verifies that the design meets the essential requirements. If satisfied, it issues an EC type-examination certificate. The manufacturer then runs internal production checks so each unit matches the approved type.

Technical File

Annex VII, Part A requires a technical file that proves compliance. It must be available before the machine is placed on the market.⁴ The construction file must contain, at minimum:

A general description of the machine.
Overall drawings and control circuit diagrams with explanations sufficient to understand how the machine operates.
Detailed drawings with calculation notes, test results, and certificates needed to verify compliance.
Risk assessment documentation showing the procedure followed, the essential requirements that apply, protective measures implemented, and any residual risks.
The standards and technical specifications used, indicating which essential requirements they address.
Test reports from the manufacturer or a chosen body.
A copy of the machine’s instructions for use.
Where relevant, declarations of incorporation for included partly completed machinery and copies of EC declarations for other incorporated products.

For series production, the file must also describe the internal measures the manufacturer uses to keep every unit in conformity. The file must be compiled in one or more official EU languages, and it must remain available to national authorities for at least ten years from the date of manufacture, or from the date the last unit of a series was made. It does not need to be physically located in the EU, but the manufacturer must be able to assemble and deliver it within a reasonable time when an authority requests it.⁴

EC Declaration of Conformity

Annex II requires a written EC Declaration of Conformity that must travel with the machine to the end user. It is a binding statement that the machinery meets all relevant provisions of the directive, and it must include ten specific items: the manufacturer’s business name and full address (and the authorized representative’s, where applicable); the name and address of the person authorized to compile the technical file, who must be established in the EU; a description identifying the machinery, including function, model, type, serial number, and commercial name; an express statement that the machinery fulfils all relevant provisions of the directive, plus references to any other applicable directives; where applicable, the name, address, and identification number of the Notified Body that performed EC type-examination, along with the certificate number; where applicable, details of the Notified Body that approved a full quality assurance system; references to harmonised standards used; references to other technical standards and specifications applied; the place and date of the declaration; and the identity and signature of the person empowered to issue the declaration on behalf of the manufacturer.²

Where the machine also falls under other EU directives, such as the Low Voltage Directive or the EMC Directive, those must be listed on the declaration with their Official Journal references. Incomplete or inaccurate declarations are among the most common enforcement triggers during import checks.

Non-EU Manufacturers and Authorized Representatives

Manufacturers based outside the EU face an added requirement. The person authorized to compile the technical file, item 2 on the Declaration of Conformity, must be established in the EU.² In practice, non-EU manufacturers either open an EU office or appoint an Authorized Representative.

The Authorized Representative holds a copy of the technical file and the current Declaration of Conformity, produces them on a reasoned request from a national market surveillance authority, and serves as the point of contact for EU authorities on conformity and safety matters. The manufacturer keeps full responsibility for the product’s actual compliance, but the representative can be held responsible by national authorities for failing to cooperate or for gaps in the documentation they are meant to maintain.

Since July 2021, Regulation (EU) 2019/1020 has added a parallel requirement. Products sold in the EU, including through online marketplaces, must have an EU-based economic operator (an importer, authorized representative, or fulfilment service provider) whose name and contact details appear on the product or its packaging.⁷

CE Marking

Once the conformity assessment is complete and the Declaration of Conformity is signed, the manufacturer affixes the CE marking. Article 16 requires the marking to be visible, legible, and indelible, following the proportions in Annex III. No other marking may be placed on the machine in a way that could be confused with the CE mark or impair its visibility.²

Market Surveillance and Penalties

National authorities in each member state carry out market surveillance to check that machinery in use continues to meet safety standards. Under Regulation (EC) No 765/2008, these authorities can inspect products, request technical files, and test machines already on the market.⁷

When authorities restrict or remove a machine from the market, Article 20 requires them to state the exact grounds for the decision, notify the affected party promptly, and inform them of the legal remedies available under national law. Article 23 requires each member state to set penalties for violations that are effective, proportionate, and dissuasive.⁴ The specific fines and enforcement mechanisms vary by country because the directive leaves the details to national law.

Transition to Regulation (EU) 2023/1230 on 20 January 2027

The directive is being replaced. Regulation (EU) 2023/1230 was adopted in June 2023 and becomes fully applicable on 20 January 2027.¹ From that date, CE marking and conformity assessment for machinery must be carried out under the new regulation.

Because the replacement is a regulation rather than a directive, it applies directly in every member state without national transposition, removing the small variations that exist today. The substantive changes reflect two decades of technological change. Digital user instructions are allowed provided they are downloadable and printable, remain accessible for the machine’s lifetime plus at least ten years, and a paper copy is supplied free within one month if the buyer asks for it at the time of purchase; machinery intended for non-professional users must still include essential safety information on paper by default. The regulation also addresses machines that use learning-based AI to perform safety functions, along with autonomous mobile robots and connected equipment, and it clarifies when modifications to existing machinery are significant enough to trigger a new conformity assessment.

Manufacturers placing machinery on the market before 20 January 2027 may still certify under Directive 2006/42/EC. Anyone designing products now should build the compliance process around the incoming regulation to avoid having to recertify.

1
European Agency for Safety and Health at Work. Regulation 2023/1230/EU – Machinery
2
EUR-Lex. Directive 2006/42/EC of the European Parliament and of the Council
3
Health and Safety Executive for Northern Ireland. Machinery Directive Definitions and Scope
4
EUR-Lex. Directive 2006/42/EC of the European Parliament and of the Council – Official Journal Text
5
European Agency for Safety and Health at Work. Directive 2006/42/EC – Machinery Directive
6
European Commission. New Harmonised Standards Which Provide Presumption of Conformity
7
EUR-Lex. Regulation (EC) No 765/2008 of the European Parliament and of the Council