Machinery CE Certification
CE Marking under the Machinery Directive 2006/42/EC
To place a machine on the market in the European Union or in Türkiye, it must bear the CE marking. CE stands for the French Conformité Européenne (European Conformity) and shows that the machine meets the essential health and safety requirements of the Machinery Directive 2006/42/EC and of any other legislation that applies to it.
The CE marking is not just a logo printed on a nameplate. Behind it there must be a correctly chosen conformity assessment procedure, a risk assessment, a technical file, the necessary tests and inspections, and a signed EC Declaration of Conformity. This page summarises the steps of machinery CE certification, the machines for which a notified body is mandatory, and the role of TESTPLUS in the process.
A Short History of the Machinery Directive
| Period | Legislation | Description |
|---|---|---|
| 1989 – 1998 | 89/392/EEC | The first Machinery Directive; mandatory in the EU from 1 January 1995. |
| 1998 – 2009 | 98/37/EC | The consolidated version of the previous directive and its amendments. |
| 29 December 2009 to date | 2006/42/EC | The Machinery Directive currently in force. Applied in Türkiye as the Machinery Safety Regulation (2006/42/EC). |
| From 20 January 2027 | (EU) 2023/1230 | The new Machinery Regulation. It will replace 2006/42/EC in the EU; the harmonisation process in Türkiye is being followed. |
Why Is CE Certification Required for Machinery?
The CE marking is a kind of “product passport” that allows a machine to move freely within the European Union and Turkish markets. Where the CE marking is mandatory – including for production lines and industrial equipment – a machine without it:
- cannot be exported to the European Union,
- cannot be sold or put into service in Türkiye,
- cannot be imported into Türkiye from third countries.
During market surveillance, machines found to lack the CE marking, the technical file or the declaration of conformity may be subject to measures such as corrective action, withdrawal from the market and administrative fines.
Which Machines Require the CE Marking?
| Situation | Is the CE marking required? |
|---|---|
| New machines, manufactured inside or outside the EU, placed on the market for the first time | Yes |
| Second-hand machines imported from outside the EU / Türkiye and made available on the market for the first time | Yes — treated as new machinery |
| Machines that have undergone substantial modification or have been completely rebuilt | Yes — the party carrying out the modification assumes the manufacturer’s responsibility |
| Businesses that manufacture machinery for their own use | Yes — own use also counts as putting into service |
| Partly completed machinery (units that cannot perform a specific application on their own and are to be incorporated into other machinery) | No — instead of the CE marking, a Declaration of Incorporation (Annex II-1.B) and assembly instructions (Annex VI) are issued |
| Safety components (light curtains, safety relays, ROPS/FOPS, etc.) | Yes — safety components are also within the scope of the Directive |
How to Obtain CE Certification for Machinery: Conformity Assessment Procedures
The manufacturer (or its authorised representative) is responsible for affixing the CE marking and placing the machine on the market. Which procedure applies depends on whether the machine is listed in Annex IV and whether harmonised standards have been applied in full.
| Machinery group | Applicable procedure | Notified body |
|---|---|---|
| Machinery outside Annex IV (the great majority of machines) | Annex VIII – Assessment of conformity with internal checks on the manufacture of machinery | Not mandatory; the manufacturer affixes the CE marking on its own declaration. Independent testing and voluntary certification are recommended. |
| Annex IV machinery — harmonised standards applied in full | Annex VIII, or Annex IX EC Type-Examination + Annex VIII point 3 internal checks, or Annex X Full Quality Assurance | Mandatory if Annex IX or Annex X is chosen |
| Annex IV machinery — harmonised standards not applied or only partly applied | Annex IX EC Type-Examination + Annex VIII point 3 or Annex X Full Quality Assurance | Mandatory |
The EC Type-Examination Certificate is reviewed by the notified body every five years. If there has been no significant change in the standards or the state of the art during that period, the certificate can be renewed. The manufacturer is obliged to inform the notified body of any modifications made to the machine.
Why Choose Voluntary Third-Party Certification?
For machinery outside Annex IV, the manufacturer declares conformity on its own, so it is the only party standing behind the product. TESTPLUS also serves this area on a voluntary basis as an independent third-party body. The benefits for the manufacturer are:
- Impartial evidence: the risk assessment, technical file and safety tests are verified against the harmonised standards by a body with no interest in the result
- Early detection: nonconformities are identified before the machine reaches the market, when they are least costly to correct
- Commercial confidence: buyers, importers and tender authorities receive documentation from an independent body
- Readiness: the manufacturer is better prepared for market surveillance and import inspections
Voluntary certificates are issued outside our notified body scope and do not replace the manufacturer’s declaration of conformity.
Annex IV: High-Risk Machinery That May Require a Notified Body
If you manufacture machinery in one of the following categories and have not applied harmonised standards in full, you must obtain an EC Type-Examination Certificate from a notified body.
| No | Annex IV machinery category |
|---|---|
| 1 | Circular saws (single- or multi-blade) for working with wood and similar materials or with meat and similar materials: 1.1 Sawing machinery with fixed blade(s) during cutting, having a fixed bed or support, with manual feed of the workpiece or with a demountable power feed 1.2 Sawing machinery with fixed blade(s) during cutting, having a manually operated reciprocating saw-bench or carriage 1.3 Sawing machinery with fixed blade(s) during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading 1.4 Sawing machinery with movable blade(s) during cutting, having mechanical movement of the blade, with manual loading and/or unloading |
| 2 | Hand-fed surface planing machinery for woodworking |
| 3 | Thicknessers for one-side dressing having a built-in mechanical feed device, with manual loading and/or unloading, for woodworking |
| 4 | Band-saws with manual loading and/or unloading for working with wood, meat and similar materials: 4.1 Sawing machinery with fixed blade(s) during cutting, having a fixed or reciprocating-movement bed or support for the workpiece 4.2 Sawing machinery with blade(s) assembled on a carriage with reciprocating motion |
| 5 | Combined machinery of the types referred to in points 1 to 4 and in point 7, for working with wood and similar materials |
| 6 | Hand-fed tenoning machinery with several tool holders for woodworking |
| 7 | Hand-fed vertical spindle moulding machinery for working with wood and similar materials |
| 8 | Portable chainsaws for woodworking |
| 9 | Presses, including press-brakes, for the cold working of metals, with manual loading and/or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s |
| 10 | Injection or compression plastics-moulding machinery with manual loading or unloading |
| 11 | Injection or compression rubber-moulding machinery with manual loading or unloading |
| 12 | Machinery for underground working: 12.1 Locomotives and brake-vans, 12.2 Hydraulic-powered roof supports |
| 13 | Manually loaded trucks for the collection of household refuse incorporating a compression mechanism |
| 14 | Removable mechanical transmission devices (cardan shafts) including their guards |
| 15 | Guards for removable mechanical transmission devices |
| 16 | Vehicle servicing lifts |
| 17 | Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than three metres |
| 18 | Portable cartridge-operated fixing and other impact machinery |
| 19 | Protective devices designed to detect the presence of persons (light curtains, laser scanners, etc.) |
| 20 | Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11 |
| 21 | Logic units to ensure safety functions (safety relays, safety PLCs, etc.) |
| 22 | Roll-over protective structures (ROPS) |
| 23 | Falling-object protective structures (FOPS) |
Tests and Checks Carried Out for Machinery CE Certification
For every machine, the basic step is the risk assessment carried out according to EN ISO 12100. It addresses all hazards, from mechanical hazards and ergonomics to the electrical equipment and control systems. The machine is then inspected against the checklist of Annex I – Essential Health and Safety Requirements of the Directive. Where a type-C (product) standard exists for the machine, the type-examination is carried out primarily against that standard.
| Standard | Subject | What is checked |
|---|---|---|
| EN ISO 12100 | Risk assessment | Hazard identification, risk estimation, risk reduction measures |
| EN 60204-1 | Electrical equipment of machines | Continuity of the protective bonding circuit, insulation resistance, voltage test, residual voltage, enclosure and wiring |
| EN ISO 13849-1 / -2 | Safety-related parts of control systems | Required performance level (PLr), category, MTTFd, DC, verification and validation |
| EN ISO 13850 | Emergency stop | Stop category, accessibility, latching and resetting |
| EN ISO 13857 | Safety distances | Distances preventing hazard zones being reached by upper and lower limbs, openings |
| EN ISO 14120 | Guards | Design and strength of fixed and movable guards |
| EN ISO 14119 | Interlocking devices | Safety switches, guard locking, measures against defeating |
| EN ISO 14118 | Prevention of unexpected start-up | Isolation and energy dissipation, prevention of restart |
| EN ISO 4413 / EN ISO 4414 | Hydraulic and pneumatic systems | Pressure limitation, hoses and connections, energy release |
| EN ISO 3744 / 3746, EN ISO 11201–11204 | Noise emission | Sound power level and sound pressure level at the operator’s position (must be declared in the instructions) |
| Type-C product standard | Machine-specific requirements | E.g. EN ISO 16092 for presses, the EN ISO 19085 series for woodworking saws, EN 280 for mobile elevating work platforms |
Each of the main tests and checks is explained below.
1. Risk Assessment (EN ISO 12100)
Risk assessment is the starting point of every machinery CE process. In accordance with EN ISO 12100, the limits of the machine are determined; mechanical, electrical, thermal, noise, vibration, ergonomic and material-related hazards are identified; the risk is estimated for each hazard; and risks are reduced by the “three-step method” (inherently safe design → safeguarding → information for use). The inspection checks whether the measures foreseen in the risk assessment have actually been implemented on the machine.
2. EHSR Checklist (2006/42/EC, Annex I)
The essential health and safety requirements in Annex I of the Directive are applied to the machine point by point; for each one, an “applicable / not applicable” decision is matched with the evidence of conformity (test report, clause of a standard, drawing, instruction). Control systems, protection against moving parts, stability, lighting, marking and the instructions are the main subjects of this check.
3. Electrical Safety Tests (EN 60204-1)
The electrical equipment of the machine is verified according to Clause 18 of EN 60204-1:
- Continuity of the protective bonding circuit
- Insulation resistance test
- Voltage (dielectric strength) test
- Protection against residual voltages
- Verification of automatic disconnection of supply (fault loop impedance)
- Functional tests and checks of the enclosure, wiring and marking
4. Safety of Control Systems (EN ISO 13849-1 / -2)
For safety-related control functions (emergency stop, interlocking, two-hand control, safe speed, etc.), the required performance level (PLr) is determined from the risk assessment. The performance level achieved by the system (PL a–e) is then calculated from the category, MTTFd, DCavg and common cause failure (CCF) parameters, and validation is carried out according to EN ISO 13849-2. Alternatively, the EN IEC 62061 (SIL) approach may be used.
5. Guards, Safety Distances and Emergency Stop
- EN ISO 13857: Safety distances and opening sizes preventing hazard zones being reached by upper and lower limbs
- EN ISO 14120: Design of fixed and movable guards
- EN ISO 14119: Interlocking devices associated with guards and measures against defeating
- EN ISO 13855: Positioning of protective devices such as light curtains with respect to approach speed
- EN ISO 13850: Type, location and category (0 or 1) of the emergency stop device, and its functional test
6. Hydraulic and Pneumatic Systems (EN ISO 4413 / 4414)
Pressure limitation, safe stopping on loss of energy, release of stored energy, protection of hoses and connections, and the consistency of the circuit diagrams with the machine are checked.
7. Noise Emission Measurement
2006/42/EC requires the noise emission values to be declared in the instructions: the A-weighted emission sound pressure level at workstations, the peak C-weighted value where it exceeds 70 dB(A), and the sound power level for machines exceeding 80 dB(A). Measurements are made according to EN ISO 3744 / EN ISO 3746 (sound power) and the EN ISO 11201 series (emission sound pressure). Equipment used outdoors may also fall under the Outdoor Noise Directive 2000/14/EC.
8. Electromagnetic Compatibility (EMC)
Machines with electrical/electronic equipment must also comply with the EMC Directive 2014/30/EU. For industrial environments, EN 61000-6-2 (immunity) and EN 61000-6-4 (emission) are usually applied. As the notified body designated in Türkiye under 2014/30/EU, TESTPLUS carries out EMC conformity assessment.
9. Type-Examination Against a Type-C Standard
Where a specific type-C standard exists for the machine (e.g. the EN ISO 16092 series for presses, EN ISO 3691-1 for lift trucks, EN 280 for mobile elevating work platforms, EN 1672-2 and the related product standards for food machinery), the inspection is carried out against the requirements of that standard. Where a type-C standard deviates from type-A and type-B standards, the type-C standard takes precedence.
What Must the Technical File Contain?
The technical file is the set of documents demonstrating that the machine complies with the Directive (Annex VII-A). It is compiled by the manufacturer, kept for at least 10 years from the date of manufacture of the last unit, and made available to the competent authorities on request.
| Section | Content |
|---|---|
| General information | Manufacturer’s details, name of the machine, models and types, differences between types |
| Description of the machine | General description, operating principle, photographs of the machine |
| Technical drawings | Overall drawing, detailed drawings, electrical, hydraulic and pneumatic diagrams |
| Calculations | Strength, stability and design calculations |
| Risk assessment | Hazards, protective measures applied and residual risks according to EN ISO 12100 |
| Standards and Annex I checklist | Standards applied and how the essential requirements are met |
| Test and inspection reports | Reports on electrical safety, control systems, noise, EMC, etc. |
| Parts lists | General parts list and list of safety-related components (with their certificates) |
| Instructions | Instructions complying with Annex I, section 1.7.4, in the language of the country of use |
| Labelling and marking | Sample nameplate, warning signs |
| Declaration of conformity | Copy of the signed EC Declaration of Conformity; internal measures ensuring conformity in series production |
How Is the EC Declaration of Conformity Drawn Up?
The EC Declaration of Conformity is the document in which the manufacturer declares, on its own responsibility, that the machine complies with the legislation. Under Annex II-1.A it must contain at least the following particulars:
| No | Mandatory particulars |
|---|---|
| 1 | Business name and full address of the manufacturer and, where appropriate, its authorised representative |
| 2 | Name and address of the person authorised to compile the technical file, who must be established in the EU or in Türkiye |
| 3 | Description and identification of the machine: generic denomination, function, model, type, serial number and commercial name |
| 4 | A sentence expressly declaring that the machine fulfils all the relevant provisions of 2006/42/EC, and the other directives applied (e.g. EMC 2014/30/EU, Noise 2000/14/EC) |
| 5 | Where applicable, the name, address and identification number of the notified body that carried out the Annex IX EC Type-Examination, and the number of the EC Type-Examination Certificate |
| 6 | Where applicable, the name, address and identification number of the notified body that approved the Annex X Full Quality Assurance system |
| 7 | Reference to the harmonised standards used |
| 8 | Reference to other technical standards and specifications used |
| 9 | Place and date of the declaration |
| 10 | Identity and signature of the person empowered to draw up the declaration on behalf of the manufacturer |
The original or a copy of the declaration of conformity must be supplied to the user together with the machine. For partly completed machinery, a Declaration of Incorporation (Annex II-1.B) is issued instead of the declaration of conformity.
How Is the CE Marking Affixed to the Machine?
The CE marking consists of the initials “CE” in the form shown in Annex III of the Directive and below. The marking may be enlarged or reduced, provided its proportions are respected.
| Rule | Description |
|---|---|
| Minimum size | The vertical dimension of the letters may not be less than 5 mm (this may be waived for small-scale machinery). |
| Position | Affixed in the immediate vicinity of the name of the manufacturer or its authorised representative, using the same technique. |
| Durability | It must be visible, legible and indelible; it usually appears on the nameplate. |
| Notified body number | The identification number of the notified body is added next to the CE marking only where the Annex X Full Quality Assurance procedure has been applied. For Annex IX EC Type-Examination, the number appears in the declaration of conformity, not next to the CE marking. |
| Misleading markings | No other markings likely to mislead as to the meaning or form of the CE marking may be used. |
The nameplate must also show the business name and address of the manufacturer, the designation of the machinery, the designation of series or type, the serial number and the year of construction (Annex I, section 1.7.3).
TAREKS Inspection for Machinery Imports into Türkiye (2026/32)
Since 1 January 2026, compliance with 2006/42/EC and the other relevant regulations has been checked through the TAREKS system when machinery is imported into Türkiye, under the Communiqué on the Import Inspection of Machinery (2026/32). For the 307 tariff codes (GTİP) subject to inspection and the documents requested, see our 2026/32 GTİP list page.
The Machinery CE Certification Process Step by Step
| Step | Activity | Responsible |
|---|---|---|
| 1 | Determining the scope of the machine and the applicable legislation (machinery safety, EMC, noise, low voltage, etc.) | Manufacturer |
| 2 | Annex IV check and selection of the conformity assessment procedure | Manufacturer |
| 3 | Risk assessment and preparation of the technical file | Manufacturer |
| 4 | Application, quotation and contract | Manufacturer – TESTPLUS |
| 5 | Technical file review, tests and inspections | TESTPLUS |
| 6 | Notification of non-conformities and their correction by the manufacturer | TESTPLUS – Manufacturer |
| 7 | Certification decision and issue of the EC Type-Examination Certificate / test reports | TESTPLUS |
| 8 | Signing of the EC Declaration of Conformity and affixing of the CE marking | Manufacturer |
Why TESTPLUS?
| Feature | Description |
|---|---|
| Notified body | NB 2908 — listed in the EU NANDO database |
| Accreditation | TÜRKAK AB-0155-U (ISO/IEC 17065) and AB-0181-YS (ISO/IEC 17021-1) |
| Three directives, one body | Machinery 2006/42/EC, Outdoor Noise 2000/14/EC and EMC 2014/30/EU — the only body in Türkiye notified under all three |
| Experience | 19 years of conformity assessment experience |
| Independence | TESTPLUS does not provide consultancy; it performs independent conformity assessment only |
Frequently Asked Questions
Is a notified body certificate mandatory for every machine?
No. For machinery outside Annex IV, the manufacturer can affix the CE marking on its own declaration under the Annex VIII internal checks procedure. Independent test reports and voluntary certification, however, make it easier to demonstrate conformity to customers and market surveillance authorities.
How long is a machinery CE certificate valid?
The EC Type-Examination Certificate is reviewed by the notified body every five years. An earlier update may be needed if the machine, the standards applied or the legislation changes.
Are a CE certificate and the CE marking the same thing?
No. The CE marking is the conformity marking that the manufacturer affixes to the machine. “CE certificate” usually refers to the manufacturer’s EC Declaration of Conformity together with the EC Type-Examination Certificate or test reports issued by a notified body.
Is the CE marking affixed to partly completed machinery?
No. For partly completed machinery, a Declaration of Incorporation (Annex II-1.B) and assembly instructions (Annex VI) are issued. The CE marking is affixed to the final machine once it has been completed.
What does the new Machinery Regulation (EU) 2023/1230 change?
The Regulation, which applies in the EU from 20 January 2027, introduces new rules on matters such as safety functions involving artificial intelligence, cybersecurity, digital instructions and substantial modification, and reorganises the list of machinery requiring a notified body. See our guide to the new Machinery Regulation (EU) 2023/1230.
Quotation and Information
TESTPLUS provides EC Type-Examination, testing and inspection services under the Machinery Directive 2006/42/EC with its team of technical experts. To find out which procedure applies to your machine or to request a quotation, please contact us.
