Machine: according to Article 3, section 1 of Regulation (EU) 2023/1230, 'machine' means:

a) an assembly, fitted with or intended to be fitted with a drive system other than direct human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application;

b) an assembly as referred to in point (a), missing only the components to connect it on site or to sources of energy and motion;

c) an assembly as referred to in points (a) and (b), ready to be installed and able to function as it stands only after being mounted on a means of transport, or installed in a building or a structure;

d) assemblies of machinery as referred to in points (a), (b) and (c), or of partly completed machinery, which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole;

e) an assembly of linked parts or components, at least one of which moves, and which are joined together, intended for lifting loads, whose only power source is direct human effort;

f) an assembly as referred to in points (a) to (e) missing only the upload of a software intended for the specific application foreseen by the manufacturer.

Partly Completed Machinery: according to Article 3, section 10, 'partly completed machinery' means:

an assembly which is almost machinery but which cannot in itself perform a specific application and which is only intended to be incorporated into or assembled with machinery or other partly completed machinery or equipment, thereby forming a machine.

The CE Marking includes a series of different certification schemes (modules). The choice of scheme is defined according to the provisions of each directive and/or regulation, the type of product, and the inherent risks of the product, which may involve the applicability of one or several of the following modules simultaneously.

• Module A (Internal Production Control): self-assessment by the manufacturer.
• Module B (EU-type Examination): evaluation and certification by a notified body.
• Module C (Conformity to type): production in conformity with an examined type.
• Module D (Production Quality Assurance): quality system in production supervised by a notified body.
• Module E (Product Quality Assurance): specific quality system for products, supervised by a notified body.
• Module F (Product Verification): evaluation of each product or a batch of products by a notified body.
• Module G (Unit Verification): individual evaluation and certification of a specific product by a notified body.
• Module H (Full Quality Assurance): total quality system covering design, production, and testing, supervised by a notified body.

Manufacturers/importers of machinery must carry out (manufacturers) or ensure that it has been carried out (importers) the conformity assessment according to Regulation (EU) 2023/1230.

The conformity assessment (certification) procedure must be carried out as indicated in Article 25 of the same Regulation (EU) 2023/1230. The conformity assessment procedure depends directly on the type of machine, partly completed machinery or safety device and its performance, as well as whether they have been manufactured in accordance with harmonised standards.

When the category of machinery or related product is included in the list of Annex I, Part A of Regulation (EU) 2023/1230, one of the following procedures must be carried out:

a) EU-type examination (module B) as described in Annex VII, followed by conformity to type based on internal production control (module C) as described in Annex VIII;

b) conformity based on full quality assurance (module H) as described in Annex IX;

c) conformity based on unit verification (module G) as described in Annex X.

When the category of machinery or related product is included in the list of Annex I, Part B, of Regulation (EU) 2023/1230, one of the following procedures must be carried out:

a) internal production control (module A) as described in Annex VI;

b) EU-type examination (module B) as described in Annex VII, followed by conformity to type based on internal production control (module C) as described in Annex VIII;

c) conformity based on full quality assurance (module H) as described in Annex IX;

d) conformity based on unit verification (module G) as described in Annex X.

If a manufacturer applies the internal production control procedure referred to in point (a) (Module A), they shall design and manufacture the machinery or related product in accordance with the harmonised standards or common specifications specific to that category of machinery or related products that regulate all the relevant essential health and safety requirements.

When the category of machinery or related product is included in the list of Annex I, Part B of Regulation (EU) 2023/1230 and the machinery or related product has not been manufactured in accordance with the harmonised standards or common specifications specific to that category of machinery or related product that regulate all the relevant essential health and safety requirements for that category of machinery or related product, one of the following procedures must be carried out:

1. b) EU-type examination (module B) as described in Annex VII, followed by conformity to type based on internal production control (module C) as described in Annex VIII;
2. c) conformity based on full quality assurance (module H) as described in Annex IX;
3. d) conformity based on unit verification (module G) as described in Annex X.
4. When the category of machinery or related product is not included in the list of Annex I of Regulation (EU) 2023/1230, the internal production control (module A) as described in Annex VI of the same regulation shall apply.

1. Manufacturer: among other responsibilities, they must ensure that the product complies with all relevant EU requirements, carry out the conformity assessment, prepare the technical file, issue the EU Declaration of Conformity, and affix the CE marking to the product.
2. Authorised Representative: if the manufacturer is not established in the EU, they may appoint an authorised representative based in the EU. This representative acts on behalf of the manufacturer for certain tasks, such as ensuring the availability of the technical file and the declaration of conformity or cooperating with the competent national authority and providing the necessary information and documentation to demonstrate the conformity of a product in case of a reasoned request.
3. Importer: broadly speaking, they must verify that products manufactured outside the EU comply with the necessary requirements before being placed on the EU market, ensuring that the manufacturer has carried out the appropriate conformity assessment and that the product bears the CE marking. Furthermore, among other possible commitments, they may be subject to registration in official databases or to paying taxes for their recycling.
4. Distributor: must ensure that the products they distribute comply with current EU legislation before marketing them, verifying that the manufacturer and importer have fulfilled their obligations.
5. Notified Body: this is an entity designated by an EU member state, independent and authorised to assess whether a product meets specific requirements. Its involvement is mandatory for certain higher-risk products.
6. Laboratory: an accredited laboratory is one that has demonstrated to a national accreditation body (e.g., ENAC in Spain) its technical competence, impartiality, and quality management according to the international standard ISO IEC 17025. Accreditation ensures that the tests it performs and the results obtained are reliable, officially recognised, and serve as a valid basis for product certification and presumption of conformity.

ANNEX I (Regulation (EU) 2023/1230)

CATEGORIES OF MACHINERY OR RELATED PRODUCTS TO WHICH ONE OF THE PROCEDURES REFERRED TO IN ARTICLE 25(2) AND (3) SHALL BE APPLIED

PART A

Categories of machinery or related products to which one of the procedures referred to in Article 25(2) shall be applied:

1. Removable mechanical transmission devices, including their guards.
2. Guards for removable mechanical transmission devices.
3. Vehicle servicing lifts.
4. Portable cartridge-operated fixing and other impact machinery.
5. Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions.
6. Machinery that embeds systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions that have not been independently placed on the market, only in respect of those systems.

PART B

Categories of machinery or related products to which one of the procedures referred to in Article 25(3) shall be applied:

1. Circular saws (single- or multi-blade) for working with wood and material with similar physical characteristics, or for working with meat and material with similar physical characteristics, of the following types:

1.1. Sawing machinery with a fixed blade or blades 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 a fixed blade or blades during cutting, having a manually operated reciprocating saw-bench or carriage;

1.3. Sawing machinery with a fixed blade or blades during cutting, having a built-in mechanical feed device for the workpieces, with manual loading and/or unloading;

1.4. Sawing machinery with a movable blade or blades during cutting, having a mechanical blade feed, with manual loading and/or unloading.

2. Hand-fed surface planing machinery for woodworking.
3. Thicknessers for one-side dressing with 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 and material with similar physical characteristics, or for working with meat and material with similar physical characteristics, of the following types:

4.1. Sawing machinery with a fixed blade or blades during cutting, having a fixed or reciprocating bed or support for the workpiece;

4.2. Sawing machinery with a blade or blades mounted on a carriage with a reciprocating motion.

5. Combined machinery of the types referred to in points 1 to 4 and point 7 for working with wood and material with similar physical characteristics.
6. Hand-fed multi-spindle tenoning machinery for woodworking.
7. Hand-fed vertical spindle moulding machinery for working with wood and material with similar physical characteristics.
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 of the following types:

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. Lifting appliances for persons, or persons and goods, involving a hazard of falling from a vertical height of more than 3 metres.
15. Protective devices designed to detect the presence of persons.
16. Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in points 9, 10 and 11 of this part.
17. Logic units to ensure safety functions.
18. Roll-over protective structures (ROPS).
19. Falling-object protective structures (FOPS).

ANNEX II (Regulation (EU) 2023/1230)

1. Guards for removable mechanical transmission devices.
2. Protective devices designed to detect the presence of persons.
3. Power-operated interlocking movable guards designed to be used as safeguards in machinery referred to in Annex I, Part B, points 9, 10 and 11.
4. Logic units to ensure safety functions.
5. Valves with additional means for failure detection intended for the control of dangerous movements on machinery.
6. Extraction systems for machinery emissions.
7. Guards and protective devices designed to protect persons against moving parts involved in the process on the machine.
8. Monitoring devices for loading and movement control in lifting machinery.
9. Restraint systems to keep persons on their seats.
10. Emergency stop devices.
11. Discharge systems for preventing the build-up of potentially dangerous electrostatic charges.
12. Energy limiters and relief devices referred to in Annex III, points 1.5.7, 3.4.7 and 4.1.2.6.
13. Systems and devices to reduce the emission of noise and vibrations.
14. Roll-over protective structures (ROPS).
15. Falling-object protective structures (FOPS).
16. Two-hand control devices.
17. The following components for machinery designed for lifting and/or lowering persons between different landings:
18. a) devices for locking landing doors;
19. b) devices to prevent the car from falling or uncontrolled upward movements;
20. c) overspeed limitation devices;
21. d) energy-accumulating shock absorbers, non-linear or with damping of the return movement;
22. e) energy-dissipating shock absorbers;
23. f) safety devices fitted to jacks of hydraulic power circuits and used to prevent falls;
24. g) safety switches containing electronic components.
25. Software that ensures safety functions.
26. Safety components with a fully or partially self-evolving behaviour using machine learning approaches that ensure safety functions.
27. Filtration systems intended to be integrated into machinery cabins to protect operators or other persons from hazardous materials and substances, including plant protection products, and filters for such filtration systems.

A risk analysis is a systematic process that identifies, assesses, and documents the potential hazards associated with a machine. Its goal is to ensure that all possible sources of risk are recognised and adequately mitigated to meet essential health and safety requirements. This analysis is fundamental for the conformity assessment and CE marking.

Laboratory tests are scientific tests carried out to verify that the product complies with the specified safety and performance requirements. These tests ensure that the product is safe and effective for its intended use, assessing aspects such as functionality, electrical safety, and electromagnetic compatibility. Laboratories may or may not be accredited for the tests they perform. The choice of an accredited laboratory will depend, in Module A (self-certification), on the manufacturer itself and the certification body (notified body) for the other modules. Accredited laboratories are subject to the requirements imposed by the accrediting body, which include procedural and management aspects (e.g., annual audits, equipment calibration, staff qualifications and competencies, specific documentation, and restriction of the services they offer). Accredited laboratories are not permitted to provide technical advice to their clients; their functions are purely for verification and evaluation.

A technical file is a set of documents that demonstrates that a machine complies with the essential health and safety requirements and describes its performance and construction details. It includes the design, manufacture, and operation of the machine, as well as the risk analysis and conformity assessments. This file is essential for obtaining the CE marking and must be available to the competent authorities.

The user manual of a machine is a document that provides clear and detailed instructions on the safe and efficient use of the product. It contains information on installation, operation, maintenance, and warnings about potential risks, ensuring that users understand how to use the device correctly and prevent damage or malfunctions.

The marking of a machine consists of the information provided directly on the machine and its packaging. This information must include essential elements such as the product name, the manufacturer, instructions for use, warnings, and the CE marking, ensuring that users have all the necessary information to use the machine safely and appropriately.

The EU Declaration of Conformity is a document in which the manufacturer declares that the machine complies with the applicable legal requirements of the CE Marking, allowing its marketing in the European Economic Area.

A Quality Management System is a set of documented procedures and processes that ensure an organisation consistently meets quality requirements and continuous improvement. It includes the planning, control, assurance, and improvement of quality at all stages of production and operation. This system is essential for ensuring the conformity and effectiveness of products.

A harmonised standard for machinery is a European standard that establishes technical specifications and compliance criteria to ensure that machines meet the safety and performance requirements stipulated by legislation. Complying with these standards facilitates the demonstration of conformity with the regulation and simplifies the certification and marketing process in the European market.

The presumption of conformity is the recognition that a machine complies with regulatory requirements because applicable harmonised standards have been used to verify its technical requirements. The presumption of conformity facilitates the evaluation and certification process of a machine, allowing it to be marketed in the European Economic Area with greater confidence and efficiency.

An Authorised Representative for machinery is a natural or legal person established in the European Union (EU) who acts on behalf of a manufacturer outside the EU. This representative, according to their mandate, ensures that products comply with regulatory requirements and is responsible for communication with competent authorities and notified bodies.

Regulation (EU) 2023/1230 replaces the old Directive 2006/42/EC, providing a more robust legal framework adapted to current technological and market demands.

Manufacturers/importers must ensure that the provisions of the new regulation are met and have successfully completed the transition no later than 14 January 2027. From this date, Directive 2006/42/EC will be repealed.