Machinery Regulation: An Essential Guide

The Machinery Regulation lays down health and safety requirements for machinery, as well as partially completed machinery. As the definition of machinery includes products with moving parts, the regulation is also relevant for consumer products such as e-bikes or trademills.

In this guide, we explain what importers and manufacturers should know about the Machinery Regulation, including documentation, CE marking, labelling, and testing requirements.

What is the Machinery Regulation?

The new Machinery Regulation will replace the old Machinery Directive. It establishes machinery requirements for ensuring that the health and safety of the following:

• Consumers
• Professional users
• Domestic animals and property
• The environment

According to Article 8, the regulation only permits the sale, or putting into service, of machinery and related products that comply with the health and safety requirements in Annex III, when properly installed, maintained, and used as intended.

Note that machinery is defined as an assembly with a drive system other than human or animal, consisting of at least one moving part. Hence, some fitness equipment is covered by the General Product Safety Regulation (GPSR) rather than the Machinery Regulation.

You can find a more detailed definition in Article 3.

When will the Machinery Regulation apply?

The Machinery Regulation will replace the old Machinery Directive and start applying on 20 January 2027.

Some articles of the regulation, however, will start applying from an earlier date. For instance, Articles 6(7), 48, and 52 have started applying since 19 July 2023. You can find more information in Article 54.

What are the differences between the Machinery Regulation and the Machinery Directive?

Requirement	Machinery Regulation (2023)	Machinery Directive (2006)
CE marking and notified body identification number (if any)	Required	Required
Traceability labelling	a. Manufacturer’s name, registered trade name or registered trade mark b. Postal address c. Website d. E-mail address e. Designation or product model, series or type f. Year of construction g. Batch or serial number	a. Business name b. Full address c. Designation of series or type d. Year of construction e. Serial number
Other labelling information	Information, warnings, signs and markings, as referenced in Annex III	Information, warnings, and signs as listed in Annex I
Documentation	a. Declaration of Conformity b. Technical documentation c. Test report d. EU type-examination certificate and other relevant documents provided by the notified body (if required)	a. Declaration of Conformity b. Technical file c. Test report d. EU type-examination certificate and other relevant documents provided by the notified body (if required)
Instructions	Required (might be provided in digital format)	Required
Conformity assessment procedures	a. Internal production control b. EU type-examination + Internal production control c. Full quality assurance d. Unit verification	a. Internal checks b. EC type-examination + Internal checks c. Full quality assurance
Notified body	Required for some types of machinery	Required for some types of machinery
Lab testing	Required	Required

Which products are covered by the Machinery Regulation?

The Machinery Regulation covers machinery (as well as partially completed machinery) and the following related products:

• Interchangeable equipment
• Safety components
• Lifting accessories
• Chains, ropes and webbing
• Removable mechanical transmission devices

Product examples

• E-bikes
• Treadmills
• Sawing machinery
• Portable chainsaws for woodworking
• Vehicle servicing lifts
• Roll-over protective structures

Exemptions

The regulation lists exempted products and equipment in Article 2(2). We list a few examples of such equipment below:

• Information technology equipment
• Amusement park equipment
• Motor vehicles meant exclusively for competition
• Electric motors

General Requirements

The Machinery Regulation establishes essential health and safety requirements in Annex III. Here are just a few examples:

a. Principles of safety integration – Machinery must be constructed such that they can be operated without putting the operator at risk.

b. Lighting – Machinery must be supplied with satisfactory lighting for the relevant operations.

c. Seating – Where permitted and appropriate, workstations integral to machinery must have seats.

d. Control devices – Control devices must contain pictograms (where appropriate) and be obviously identifiable, and visible.

e. Risk of breakup during operation – Machinery parts and linkages must withstand usage stresses.

Standards

Importers and manufacturers can generally use harmonised standards to achieve a presumption of conformity with relevant regulations. In practice, this means that if machinery products comply with relevant harmonised standards, then one can assume that the product also complies with the Machinery Regulation’s requirements.

We couldn’t find any standards harmonised under the Machinery Regulation. However, there are harmonised standards under the Machinery Directive, and you can find them on CENELEC.

Here are a few examples:

a. EN ISO 14121-1 – Safety of machinery – Risk assessment – Part 1: Principles

b. EN 1037 – Safety of machinery – Prevention of unexpected start-up

c. EN ISO 13850 – Safety of machinery – Emergency stop function – Principles for design

Conformity Assessment Procedures

1. Manufacturers should apply one of the following conformity assessment procedures for categories of machinery products listed in Annex I, Part A:

a. EU type-examination procedure (Module B) and Conformity to type based on internal production control (Module C)

b. Conformity based on full quality assurance (Module H)

c. Conformity based on unit verification (Module G)

2. As for machinery listed in Annex I, Part B, they should apply one of the following conformity assessments:

a. Internal production control (Module A) – Only if the machinery is compliant with harmonised standards and relevant health and safety requirements

b. EU type-examination procedure (Module B), and Conformity to type based on internal production control (Module C)

c. Conformity based on full quality assurance (Module H)

d. Conformity based on unit verification (Module G)

3. Module A should be used if the product is not listed in Annex I.

Summary

In this table, we list the differences among between the different conformity assessment procedures.

Requirements	Module A	Module B+C	Module G	Module H
Scope	a. Machinery not listed in Annex I b. Machinery listed in Annex I, Part B (if harmonised standards are used) Note: The other procedures can also be used for point b.	a. Machinery listed in Annex I, Part A b. Machinery listed in Annex I, Part B Note: Other procedure can also be used	a. Machinery listed in Annex I, Part A b. Machinery listed in Annex I, Part B Note: Other procedure can also be used	a. Machinery listed in Annex I, Part A b. Machinery listed in Annex I, Part B Note: Other procedure can also be used
Notified body’s identification number label	/	Required	Required	Required
Other documentation	/	a. Evaluation report b. EU type-examination certificate	/	Quality system documentation
Notified body	/	Required	Required	Required

Documentation

Importers and manufacturers should generally ensure that they can provide relevant documentation upon request. In this section, we explain the documentation requirements regarding machinery and related products.

Declaration

The regulation requires manufacturers to provide either a Declaration of Conformity for machinery and related products or an EU declaration of incorporation for partially completed machinery.

Declaration of Conformity (DoC)

• Identification of machinery product
• Manufacturer’s name and address
• Product traceability identification information (e.g. a colour image)
• Statement declaring conformity with relevant regulations
• References to harmonised standards, or technical specifications, used
• Address of permanent installations (e.g., for lifting machinery)
• Notified body performance statement (where applicable)
• A statement reflecting the product’s subjection to conformity assessment
• Location and date of issue
• Issuer’s name, function, and signature

Declaration of Incorporation

You can find the format of the Declaration of Incorporation in Annex V, Part B.

Technical documentation

The regulation requires, per Annex IV, the provision of technical documentation, which is a collection of documents relevant to the products and their compliance with the requirements. While Part A of the Annex sets documentary requirements for machinery, Part B sets documentary requirements for partially-completed machinery.

Instructions

Machinery manufacturers must draw up usage instructions according to the health and safety requirements set out in Annex III of the regulation. According to the general principles for drafting the instructions, the content must:

• Cover the machinery’s intended use
• Account for reasonably foreseeable misuse
• Account for the education level of non-professional operators

Additionally, Annex XI of the regulation lays out requirements regarding assembly instructions for partially completed machinery.

Test reports

The Machinery Regulation requires machinery manufacturers to provide relevant test reports as part of their documentation files.

The test reports are provided by lab testing companies, upon testing the machinery according to the relevant standards and requirements.

Other documents

If manufacturers utilise a notified body’s services, they might need to provide quality system documentation (e.g., quality programmes, plans, manuals, and records).

Additionally, the notified body should draw up an evaluation report, and an EU type-examination certificate, if the product complies with all necessary requirements.

Labelling

Importers and manufacturers of machinery should ensure that their products are adequately labelled with items such as CE markings and traceability information.

CE marking

According to Article 24, the CE marking must be:

a. Obviously, clearly, and permanently affixed to the machinery, or when that is not possible, the machinery’s packaging and documents.

b. Affixed before the machinery is put on sale or into service.

c. Followed by the notified body’s identification number if a conformity assessment was performed.

Note that a pictogram or a particular risk indication marking may follow the CE marking (and, where applicable, the notified body’s identification number).

Traceability information

Manufacturers must make sure that their machinery products, or the packaging or its documentation, carry traceability information, such as:

• Product model, series, type, batch or serial number
• Year of construction (or year of completion of manufacturing)
• Manufacturer’s name or registered trademark
• Manufacturer’s postal address and website
• Manufacturer’s email address

Other requirements

The regulation requires manufacturers to properly mark their machinery or related products. For example, they should mark machinery meant for use in potentially explosive atmospheres. It also requires to affix relevant signs, and warnings.

You can find more details about these requirements for machinery in Annex III of the regulation.

Lab testing

Manufacturers of machinery often need to have their products lab tested to prove that their products comply with relevant safety requirements in the Machinery Regulation, as well as relevant harmonised standards.

After the product has passed testing, manufacturers receive a test report indicating that the machinery complies with the relevant requirements.

Lab testing companies

Here are a few examples of companies that offer to test against either the old Machinery Directive or the new Machinery Regulation:

• Intertek
• SGS
• Bureau Veritas
• TÜV Rheinland

Notified bodies

Manufacturers may sometimes need a notified body to perform a conformity assessment, which includes testing. However, according to the European Commission’s website, there is still no official information regarding notified bodies offering services for this regulation.

Having said that, in the above linked page you can find a list of notified bodies for the Machinery Directive. Here are some examples:

• TÜV SÜD Industrie Service GmbH – Germany
• Apave Exploitation France SAS – France
• Aboma Inspections B.V. – Netherlands
• MTIC InterCert S.r.l. – Italy