Notice: The Machinery Directive is currently undergoing a transition period. During this time, provisions from the Machinery Directive 2006/42/EC (hereinafter referred to as the Machinery Directive or Directive) apply jointly with some provisions from the Machinery Regulation (EU) 2023/1230 (hereinafter referred to as the Machinery Regulation or Regulation). This transition period is expected to last until the 20^th of January 2027, after which Regulation (EU) 2023/1230 will apply in its entirety.

This page is being updated actively to reflect the current state of play during this period.

Legislation Regulating Machinery in the EU

The Machinery Directive 2006/42/EC is a key European Union directive that lays down the essential health and safety requirements for the design and construction of machinery, thereby providing a high level of protection to the consumer. Machinery may be placed on the market and/or put into service only if it satisfies the relevant provisions of the Directive and does not endanger the health and safety of persons and, where appropriate, domestic animals or property, when properly installed and maintained and used for its intended purpose or under conditions which can reasonably be foreseen. The Directive was nationally transposed by means of Subsidiary Legislation 430.36.

The Machinery Regulation (Regulation (EU) 2023/1230) introduces significant updates and changes to the present Machinery Directive. The Regulation entered into force on the 19^th of July 2023. A corrigendum has been issued to address a clerical error as regards the application dates in the original version. See the latest consolidated version of the Machinery Regulation. The Regulation will fully apply from the 20^th of January 2027, replacing the Directive.

In the present transitional period, Member States shall not impede the making available on the market of products which were placed on the market in conformity with Directive 2006/42/EC before this date. However, certain provisions of the Regulation apply as per the following timeline.

 As April 2025, the following provisions of the Machinery Regulation have already taken effect.

• Article 6(2) – (8), (11), 26 – 42, 47, 48, 50(1), 52 and 53(3).
• Chapter VI of the new Regulation applies to products placed on the market under Directive 2006/42/EC, superseding Article 11 of that Directive.

What is next?

As of the 20^th of January 2027:

• Directive 2006/42/EC will officially be repealed.
• The new Regulation will fully apply, replacing the repealed Directive.
• Products that conform to Directive 2006/42/EC (placed on the market before this date) shall continue being available on the market.

EC type examination certificates (Declaration of Conformity – DoC and Declaration of Incorporation – DoI) issued under Directive 2006/42/EC shall remain valid until they expire.

Further Legislation

In the context of machinery, further legislation may be applicable. It is the responsibility of the manufacturer to identify the applicable legislation, design and construct the machinery according to the essential health and safety requirements of said applicable legislation. Furthermore, it is the responsibility of the importer to ensure that the product being placed on the market complies with all applicable legislation.

In machinery, further legislation may apply accordingly. EMC, LVD, RED, Batteries and RoHS concerning machinery with combined low voltage devices, batteries and / or radio equipment; PED and SPVD in cases where pressure equipment is used; NRMM and / or Batteries in cases where the machine is mobile and is propelled by an internal combustion engine or a battery drive train; and ATEX when the machine is intended to be used in explosive atmospheres. Over and above these legislations, the provisions of GPSR may apply where certain risks are not otherwise covered by any specific EU law.

Machinery may also fall within the scope of other legislations that could be either under the remit of MCCAA or other entities such as, but not limited, to Cybersecurity and Artificial Intelligence.

Aim of the Machinery Regulation

The Machinery Regulation expands the definition of machinery to cover a wider range of products and technologies that have overtaken the provisions of the Machinery Directive since its enactment in 2006. Such technologies include, but are not limited to, cloud connectivity and remote access to machinery, machines with self-evolving behaviour and the advent of new consumer products such as 3D printers, e-bikes and e-scooters which presently are not subject to EU type approval.

In light of new risk categories, the Machinery Regulation lays out new risk assessment procedures and safety requirements. Such requirements are intended to address, for example, future updates or developments to the software and other embedded systems in a product. Risk assessment shall also assess risks that might develop during the product’s lifecycle due to an intended evolution of its behaviour when operating with varying levels of autonomy. Furthermore, the Machinery Regulation requires manufactures to assess all the interactions of a machine system comprised of an assembly of other machinery in their risk assessment. It is the legal obligation of the manufacturer to ensure that the machinery product complies with all applicable requirements of all the applicable legislation.

What Falls Under the Scope of the Machinery Directive?

Article 1 of Directive 2006/42/EC lays out the scope of said directive.

• Is it machinery?

Does it have moving parts powered by something other than human or animal effort?

This includes systems like conveyor belts, robotic arms, or any assembly where at least one part moves. If it is designed for a specific task using a drive system, it qualifies as machinery.

The term “machinery” is defined in Article 2(a) of the Directive.

Please refer to Article 2.

• Does it change the function of existing machinery?

Is it interchangeable equipment added by the operator to alter functionality?

Examples include attachments for tractors or devices that modify a machine's capabilities. If it can be assembled with machinery to provide new functions, it fits this category.

• Is it a safety component?

Does it serve a safety function, is it sold separately, and could it endanger safety if it fails?

This includes items like emergency stop switches, safety barriers and other components listed in Annex V. If the failure of this component could result in harm, it is classified as a safety component.

• Does it lift loads?

Is it specifically designed for lifting?

This encompasses lifting accessories such as slings, chains, ropes, and webbing used to hoist or support loads. If it plays a role in lifting operations, it qualifies.

• Does it transmit power?

Is it a removable mechanical transmission device that connects machines?

This could include drive shafts or couplings that transmit power from one machine to another. If it facilitates power transfer, it falls under this category.

• Is it partly completed machinery?

Is it an assembly that needs additional parts to function?

Examples include engines or components that must be integrated with other machinery to become operational. If it cannot perform a specific task on its own, it is considered partly completed machinery.

List of Excluded Products

What are the Obligations of the Manufacturer or Authorised Representative?

A manufacturer is any individual or organization that designs or produces machinery or partly completed machinery in compliance with this Directive. If there is no identifiable manufacturer within the EU, the individual or organization that markets or puts the machinery into service will be regarded as the manufacturer.

An authorised representative refers to any natural or legal person established in the Community who has received a written mandate from the manufacturer to perform on its behalf all or part of the obligations and formalities connected with this Directive.

Before placing machinery on the market and/or putting it into service the manufacturer or his authorised representative shall:

• Ensure that it satisfies the relevant essential health and safety requirements.
• Ensure the availability of the technical file for machinery or partly completed machinery.
• Provide the necessary information, such as instructions. In the case of partly completed machinery, assembly instructions shall be prepared.
• Carry out the appropriate procedures for assessing conformity for the machinery (Article 12) or partly completed machinery (Article 13).
• Draw up the EC Declaration of Conformity (DoC) in accordance with Section A and ensure that it accompanies the machinery. In the case of partly completed machinery the manufacturer shall prepare a Declaration of Incorporation (DoI), referred to in Section B. In either case, the manufacturer shall keep the original EC declaration for a period of at least 10 years from the last date of manufacture of the machinery.
• Affix the CE marking in accordance with Article 16.
• Where machinery is also the subject of other Union legal acts relating to other aspects and providing for the affixing of CE marking, the marking shall indicate that the machinery also conforms to the provisions of those other Union legal acts.
• Manufacturers may also be required by other Union legal acts to draw up an EC Declaration of Conformity. To ensure effective access to information for market surveillance purposes, a single EU Declaration of Conformity may be drawn up in respect of all Union legal acts. Make the product conform to the relevant provisions of the Directive and put an end to an infringement if it is found to not conform by a Member State’s market surveillance authority.

While the Machinery Directive gives the authorised representative the possibility to perform all the tasks of the manufacturer (provided these tasks are specified in a mandate written by the manufacturer), under the Regulation, the capabilities of the authorised representative have been restricted. Refer to the Regulation, which clarifies the obligations of the manufacturer and the authorised representative.

What are the Obligations of Importers and Distributors?

According to Article 2(i) of the Directive, in the absence of a manufacturer, any natural or legal person who places on the market or puts into service machinery shall be considered a manufacturer. As such, other economic operators such as importers and distributors are to fulfil their obligations as laid out in Article 5.

Under the new Machinery Regulation, specific obligations have been laid out for the importers and distributors.

Lifting Machinery

In addition to the General Principles set out in Annex I of Directive 2006/42/EC, machinery presenting hazards due to lifting operations (i.e. lifting machinery and not to be confused with lifts and safety components that fall under scope of the Lifts Directive) shall meet the essential health and safety requirements (EHSRs) described in Annex I, Section 4 – Supplementary EHSRs to offset Hazards due to Lifting Operations. The roles of the authorised representative and the manufacturer are often interchangeable in Directive 2006/42/EC. However, the adoption of Regulation (EU) 2023/1230 comes with major revisions specifying what the authorised representative can and cannot do.

The table below shows the present capabilities of an authorised representative allowed under the Directive and what shall change under the new Regulation. These obligations shall be met when the Directive is repealed, and the Regulation is fully applicable on the 20^th of January 2027.

* As applicable from the 20^th of January 2027.

Therefore, under the new Machinery Regulation the manufacturer follows through the entire lifecycle of the lifting machinery. The manufacturer shall ensure that the EHSRs have been met by adequate design, manufacture and testing of the lifting machinery. The manufacturer cannot mandate the authorised representative to fulfil these tasks any longer. The authorised representative may however retain the role of affixing the CE marking and cooperate with the competent local authorities.

Safety Components: An indicative list of safety components concerning lifting machinery is laid out in Annex II (17).

Conformity Assessment: Lifting machinery is categorised under Annex I (Part B) as “Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than 3 m.” As per the provisions of Article 25 of the Regulation, the manufacturer or the natural or legal person referred to in Article 18 shall apply one of the following conformity assessment procedures:

1. Internal Production Control
2. EU Type Examination followed by Conformity to Type Based on Internal Control
3. Conformity Based on Full Quality Assurance
4. Conformity Based on Unit Verification

It shall be noted how “Vehicle servicing lifts” are categorised under Annex I (Part A) and are therefore subject to a different set of conformity assessment procedures.

Declaration of Conformity: As per Annex V (3) of the Machinery Regulation, the DoC of lifting machinery assembled at the place of use, shall now also include the address of that place.

Further Information and Guidelines

Guide to Application of the Machinery Directive 2006/42/EC

Information About the CE Marking

Guidance on CE Marking for Professionals

Guidance on Conformity Assessment Procedures for 3D Printing and 3D Printed Products

Application Guide: Ergonomic Health and Safety Requirements

The ‘Blue Guide’ on the Implementation of EU Product Rules

List of Notified Bodies

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