How to CE Mark a Machine in 5 Steps

This article covers many of the key steps that must be followed to CE mark machinery in accordance with the requirements laid out in the Machinery Regulation (EU) 2023/1230. This guide is relevant for products that belong to the following categories:

• Machinery
• E-bikes
• Electrical scooters
• Power tools
• Household appliances

This guide is based on the requirements applicable to machinery, not partly completed machinery.

Step 1: Machinery Regulation Requirements

The first step of the process is to determine whether your product is defined as machinery in the first place. Once this has been established, you must also determine which conformity assessment procedure to follow and if you need to involve a notified body.

This determines the direction of the entire CE marking process, which is why these questions must be answered early on.

a. Is your product covered?

The Machinery Regulation provides an extensive definition of what machinery is. The following definition can be found in Article 3:

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(a) an assembly, fitted with or intended to be fitted with a drive system other than directly applied 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 referred to in point (a), missing only the components to connect it on site or to sources of energy and motion;

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

(d) assemblies of machinery 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 and whose only power source is directly applied human effort;

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

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In short, a device with moving parts powered by an electrical motor or other non-human or animal force is generally covered by the Machinery Regulation.

For context, a “human-powered” gym machine is generally not covered by the Machinery Regulation and should therefore not be CE marked.

b. Identify Conformity Assessment Process

Now that you have established that your product is covered by the regulation, it’s time to identify the relevant conformity assessment process. This process impacts whether you need a notified body and other requirements.

Products	Conformity Assessment Process
Machinery listed in Part A of Annex I	Apply one of the following: Module B (Annex VII) + Module C (Annex VIII) Module H (Annex IX) Module G (Annex X)
Machinery listed in Part B of Annex I	Apply one of the following: Module A (Annex VI) Module B (Annex VII) + Module C (Annex VIII) Module H (Annex IX) Module G (Annex X)
Machinery not listed in Part A or B of Annex I	Module A (Annex VI)

This is how you can determine which conformity assessment process to follow for your machine:

a. Go to the Machinery Regulation on EUR Lex

b. Look up Part A and B of Annex I – Is your machine listed?

c. Select the relevant modules

d. If not listed in Part A or B of Annex I, then follow Module A

c. Is a notified body required?

Certain modules require the involvement of a Notified Body.

Module	Notified Body Required
Module A	No
Module B	Yes
Module C	No
Module H	Yes
Module G	Yes

Step 2: Find applicable machinery standards

The Machinery Regulation essentially requires that machinery sold and used within the European Union is safe. However, it does not provide technical specifications for how this can be achieved. Instead, the regulation requires manufacturers to follow applicable harmonised standards.

Harmonised standards apply to specific safety aspects or types of machinery. You can see harmonised standards as roadmaps for how you can, in technical terms, ensure that the machine meets certain mechanical and electrical safety requirements.

Examples

EN 62841-4-1 – Electric Motor-Operated Hand-Held Tools, Transportable Tools and Lawn and Garden Machinery – Safety – Part 4-1: Particular requirements for chain saws

EN 62841-2-21 – Electric motor-operated hand-held tools, transportable tools and lawn and garden machinery – Safety – Part 2-21: Particular requirements for hand-held drain cleaners

EN 15194 – Cycles – Electrically power assisted cycles – EPAC Bicycles

EN 60335-2-79 – Household and similar electrical appliances – Safety – Part 2-79: Particular requirements for high pressure cleaners and steam cleaners

EN 60335-2-65 – Household and similar electrical appliances – Safety – Part 2-65: Particular requirements for air-cleaning appliances

EN 60335-2-8 – Household and similar electrical appliances – Safety – Part 2-8: Particular requirements for shavers, hair clippers and similar appliances

EN 17352 – Power operated pedestrian entrance control equipment – Safety in use – Requirements and test methods

EN 17106-2 – Road operation machinery – Safety – Part 2: Specific requirements for road surface cleaning machines

EN 16770 – Safety of woodworking machines – Chip and dust extraction systems for indoor installation – Safety requirements

EN 15830 – Rough-terrain variable reach trucks – Visibility – Test methods and verification

EN 14466 – Fire-fighting pumps – Portable pumps – Safety and performance requirements, tests

EN 12978 – Industrial, commercial and garage doors and gates – Safety devices for power operated doors and gates – Requirements and test methods

Design for compliance

As mentioned, harmonised standards set technical requirements that aim to ensure that machinery in the EU is safe for the operator. This, in turn, requires that the components, design, and functionality of the machine are designed to comply with applicable standards in the first place.

In practice, manufacturers must adjust everything from technical design files to the software to ensure that the machine conforms. If not, you will end up wasting money on testing and certification of a machine that is inherently non-compliant.

Step 3: Create label files

The Machinery Regulation sets labelling requirements for covered machinery. This includes the CE mark and other label items. Note that some information may need to be affixed by the notified body.

CE mark

Article 24 mandates that the CE mark be affixed on the machinery by the time it is put into service. The purpose of the CE mark is to demonstrate that the machine is compliant with the Machinery Regulation in its entirety.

Notified body number

The CE mark must be followed by the number of the notified body, if it is covered by a module that in turn mandates the involvement of a notified body.

Traceability information

Manufacturers should provide the following traceability information with their machinery:

• Designation, or related product model, series or type
• Year of construction
• Batch or serial number
• Manufacturer name, registered trade name or trade mark
• Postal address
• Website
• E-mail address or other digital contact information

If the size of the machinery prevents you from affixing the above information on it, you can instead provide it on the packaging or in an accompanying document, such as the instructions.

Warnings and instructions

1. According to the “Essential Health and Safety Requirements” in Part B of Annex III, you should provide information and warnings in the form of easily understandable symbols or pictograms, if possible.

Verbal information and warnings should be provided in a language that can be understood by the user.

2. Requirements concerning the instructions for the use of the machinery are listed under Point 1.7.4 of Part B of Annex III:

• General principles for the drafting of instructions for use
• Contents of the instructions for use

3. Note that there exist specific warning and instruction provisions in Point 2, 3, and 4 of Part B of Annex III.

For example, the instructions for use for machinery for foodstuffs should indicate methods for cleaning, disinfecting and rinsing.

Step 4: Machinery Testing

As mentioned, ensuring compliance with the Machinery Regulation requires that the device is compliant with applicable harmonised standards. This is, in most cases, done through testing the machine according to the relevant parts of such harmonised standards.

Once completed, you will receive a test report that is included in your technical documentation in the next step.

Step 5: Create documentation

Now that we have affixed labelling and completed testing, we can finally wrap up the process by creating the required documentation. Note that the exact documentation requirements depend on the applicable conformity assessment procedures.

Declaration of Conformity

The manufacturer must create a Declaration of Conformity which includes the following:

1. Machinery model name, batch or serial number

2. Manufacturer name and address

3. Authorised representative name and address

4. This declaration of conformity is issued under the sole responsibility of the manufacturer (statement)

5. An image of the machinery (to ensure it can be identified)

6. List of applicable EU regulations and directives (this must at least include the Machinery Regulation)

7. List of harmonised standards

8. Information about the notified body involved (if any)

9. Module A statement (if this is the module that applies to your machinery)

The Declaration of Conformity must also be signed and dated.

EU Type-Examination Certificate

Machinery for which module B is applied also requires the issuance of an EU type-Examination Certificate. This certificate can only be issued by a Notified Body after the completion of a review process.

Technical Documentation

The type of technical documentation manufacturers should draw up depends on whether or not the machinery is partly completed.

According to Article 10, manufacturers should draw up the technical documentation per the requirements in Part A of Annex IV before selling machinery or related products.

Article 11, on the other hand, specifies that manufacturers should draw up the technical documentation according to the requirements in Part B of Annex IV before selling partly completed machinery.

User instructions

Article 10 specifies that manufacturers of machinery or related products should provide instructions for use in digital form. When requested by the user, the manufacturer should also provide the instructions in paper format.

When providing the instructions in digital format, the manufacturer should:

a. Indicate on the machinery, its packaging, or accompanying document, ways of accessing the digital instructions

b. Make the instructions printable and downloadable

c. Ensure the instructions describe the corresponding product model

As also explained under Step 3: Create label files, you can find general principles and content requirements for the instructions in Part B of Annex III.

Note that some of the requirements are only relevant for specific types of machinery (e.g. machinery for foodstuffs)