Machinery Regulation Compliance: The Requirements and the Steps from Design to CE Marking

Article 10 of the Regulation sets these duties, and further duties under Article 10 continue after placing on the market.

Regulation (EU) 2023/1230 applies from 20 January 2027 and is directly applicable in every Member State. It replaces Directive 2006/42/EC, which applies until 19 January 2027 through national transpositions, with no parallel period. How the rest of the EU Machinery Regulation fits together is explained on the home page.

The sections below summarise ten compliance steps with their article and annex, the three support pages, the differences from the Directive and the status as of 12 November 2026, with each step routed to the page that sets it out in full.

What Does Machinery Regulation Compliance Require?

Machinery Regulation compliance requires the manufacturer to ensure, under Article 10(1) of Regulation (EU) 2023/1230, that the product is designed and constructed in accordance with the essential health and safety requirements of Annex III, and, under Article 10(2), to draw up the technical documentation and carry out the Article 25 procedure before placing it on the market.

Design comes first, because the Annex III requirements decide what the documentation records and what the procedure checks.

Where the procedure demonstrates compliance, the manufacturer draws up the EU declaration of conformity under Article 21 and Annex V, Part A, and affixes the CE marking under Article 24 (Article 10(2), second subparagraph).

By drawing up the declaration, the manufacturer assumes responsibility for the compliance of the product (Article 21(4)). The consolidated text of Regulation (EU) 2023/1230 on EUR-Lex holds every duty quoted on this page.

Compliance does not end when the product leaves the factory. The manufacturer keeps the technical documentation and the EU declaration of conformity for at least 10 years after placing on the market or putting into service (Article 10(3)) and carries the post-market duties described in Step 10.

Who Has to Comply: Manufacturers and Those Treated as Manufacturers

The manufacturer carries every compliance step, and the Regulation names four economic operators in Article 3(22): manufacturer, authorised representative, importer and distributor. Each operator has its own duties, but the design duty and the technical documentation stay with the manufacturer.

Two articles turn another person into the manufacturer. An importer or distributor becomes the manufacturer when it places a product on the market under its own name or trademark, or modifies a product already placed on the market so that compliance may be affected (Article 17).

Whoever substantially modifies machinery becomes its manufacturer under Article 18, while a non-professional user modifying a machine for own use does not.

The authorised representative cannot be mandated with the Article 10(1) design duty or with drawing up the technical documentation (Article 12(1), second subparagraph). The duties of each operator are set out in obligations under the Machinery Regulation.

The Compliance Steps from Design to CE Marking

The compliance steps under the Machinery Regulation run from confirming scope and Annex I status, through the risk assessment, Annex III design and the Article 25 procedure, to the technical documentation, instructions, EU declaration of conformity and CE marking, followed by the duties after placing on the market.

The order follows Article 10(1) and (2): design to Annex III first, then the technical documentation and the procedure, then the declaration and the marking.

Table 1 maps each step to its legal basis in Regulation (EU) 2023/1230, the output it produces and the page that covers it in full.

Step 1: Confirm the Product Falls within the Regulation

The Regulation covers seven product categories: machinery, five related products listed in Article 2(1)(a) to (e) and partly completed machinery.

The five related products are interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, and removable mechanical transmission devices; together with machinery and partly completed machinery they form the "products within the scope of this Regulation".

Article 2(2)(a) to (q) of Regulation (EU) 2023/1230 excludes 17 groups of products, so a product that fits a category may still fall outside the Regulation. Machinery itself has six limbs in Article 3(1)(a) to (f), the last covering an assembly that lacks only the upload of the application software.

Step 2: Check Whether the Product Is Listed in Annex I

Annex I of Regulation (EU) 2023/1230 lists 25 high-risk categories, 6 in Part A and 19 in Part B, and decides whether a notified body takes part in Step 5. A product that is not listed follows internal production control alone.

Part A points 1 to 4 were points 14, 15, 16 and 18 of Annex IV of Directive 2006/42/EC, which had 23 points in total. Annex I has not been amended since adoption: neither Regulation (EU) 2024/2748 nor Article 3 of Regulation (EU) 2026/1744 changes it.

Step 3: Carry Out and Document the Risk Assessment

The manufacturer ensures that a risk assessment determines which essential health and safety requirements apply, as an iterative process of five steps (a) to (e) set by Annex III, Part B, point 1. The five steps are listed below.

1. Determine the limits of the product, including its intended use and reasonably foreseeable misuse.
2. Identify the hazards the product can generate.
3. Estimate the risks.
4. Evaluate the risks.
5. Eliminate the hazards or reduce the risks.

Risk reduction follows the order of Annex III, section 1.1.2(b): inherently safe design first, then protective measures, then information to users on residual risks, including whether particular training is required and which personal protective equipment to use.

The results go into point (b) of Annex IV, Part A, which lists the applicable requirements, the protective measures for each and the residual risks. The assessment therefore feeds both the design of Step 4 and the documentation of Step 6.

Step 4: Design to Annex III and Apply Harmonised Standards

Annex III of Regulation (EU) 2023/1230 contains the essential health and safety requirements in nine definitions (Part A), five general principles (Part B) and six chapters, and its requirements apply only where the corresponding hazard exists, while sections 1.1.2, 1.7.3 and 1.7.4 always apply.

The requirements are mandatory; where the state of the art prevents meeting them, the product is designed to approach their objectives as far as possible (general principle 3).

A harmonised standard is a European standard adopted on a request from the Commission (Article 3(24)). A product built to a harmonised standard whose reference is published in the Official Journal is presumed to conform with the requirements that standard covers (Article 20(1); Article 7(2) of Directive 2006/42/EC).

The EU declaration of conformity names each harmonised standard applied with the date of publication of its reference (Annex V, Part A, point 7). What type A, B and C harmonised standards for machinery each cover is set out separately.

Step 5: Apply the Article 25 Conformity Assessment Procedure

Article 25 of Regulation (EU) 2023/1230 sets the procedure by product class: products not listed in Annex I use internal production control (module A) only, Annex I Part A products use module B+C, H or G, and Annex I Part B products use module A only when built to harmonised standards or common specifications specific to that category covering all relevant requirements, otherwise B+C, H or G.

The procedure is applied by the manufacturer or by the person who substantially modifies the product under Article 18 (Article 25(1)).

The modules sit in five annexes of the Regulation: module A in Annex VI, module B in Annex VII, module C in Annex VIII, module H in Annex IX and module G in Annex X. A notified body takes part in B+C, H and G and never in module A.

Step 6: Compile the Technical Documentation (Annex IV, Part A)

The technical documentation contains the 15 points (a) to (o) of Annex IV, Part A, and is drawn up before the product is placed on the market or put into service (Article 10(2)). Point (b) holds the risk assessment and point (e) the references of the harmonised standards or common specifications applied.

Three points have no counterpart in Annex VII, Part A of Directive 2006/42/EC: (h) the production means, (m) the source code or programming logic of safety-related software, supplied on reasoned request, and (n) a description for products fed by sensor data, remotely driven or autonomous.

The manufacturer keeps the documentation for at least 10 years after placing on the market or putting into service (Article 10(3)), and the authorised representative cannot draw it up (Article 12(1), second subparagraph). How the technical file, instructions and declarations relate is compared on the machinery documentation page.

Step 7: Write the Instructions and Safety Information

Instructions under Annex III, section 1.7.4.2(1) of Regulation (EU) 2023/1230 cover 24 points, (a) to (x), against 22 in the Directive, and Article 10(7) allows them in digital format.

Digital instructions come with three conditions under Article 10(7): the product or its documentation states how to access them, they are in a format that can be printed, downloaded and saved, and they stay online during the expected lifetime of the product and for at least 10 years after placing on the market.

A user who asks at the time of purchase receives a paper copy free of charge within one month.

Safety information is supplied on paper where the product is intended for, or can reasonably be expected to be used by, non-professional users. The language is one "which can be easily understood by users, as determined by the Member State concerned".

Step 8: Draw Up and Sign the EU Declaration of Conformity

The EU declaration of conformity states that the fulfilment of the applicable essential health and safety requirements of Annex III has been demonstrated (Article 21(1)) and carries the 10 particulars of Annex V, Part A. It is drawn up for each model of machinery or related product and kept continuously updated.

One declaration covers all Union acts that require one, identifying each act with its publication reference (Article 21(3)). The declaration accompanies the product, or the instructions give the internet address or machine-readable code where it can be accessed (Article 10(8)); a digital declaration stays online for the expected lifetime and at least 10 years.

The Directive's item "name and address of the person authorised to compile the technical file" has no counterpart in Annex V, Part A.

Step 9: Affix the CE Marking Before Placing on the Market

The manufacturer or its authorised representative affixes the CE marking visibly, legibly and indelibly before the product is placed on the market or put into service (Article 24(1) and (2) of Regulation (EU) 2023/1230, Article 30(1) of Regulation (EC) No 765/2008).

Article 23 of the Regulation applies the general principles of Article 30 of Regulation (EC) No 765/2008, so the marking is at least 5 mm high (Annex II, point 3 of that Regulation).

After module H or module G, the notified body's identification number follows the marking (Annex IX, point 5.1; Annex X, points 4 and 5.1).

The Commission's impact assessment SWD(2021) 82 of 21 April 2021 counted 82,239 machinery manufacturers, 81,024 of them SMEs, and estimated a one-off EUR 202 million (EUR 2,467 per company) for removing internal checks for Annex IV machinery. These are dated industry-based estimates, not current prices.

The Commission does not recognise voluntary or additional certificates as a means of proving compliance; they have no value in market surveillance or customs checks.

Step 10: Meet the Post-Market Duties and Market Surveillance Requests

Compliance continues after placing on the market: the manufacturer keeps series production in conformity (Article 10(4)), marks each product with its type designation, year of construction and batch or serial number (Article 10(5)), and gives its name, postal address, website and digital contact (Article 10(6)). These procedures account for changes in design and in the standards applied.

A product that presents a risk triggers immediate corrective action, withdrawal or recall, and the manufacturer informs the competent national authorities (Article 10(9)). Every economic operator names, on request, the operators that supplied it and those it supplied, and keeps that information for at least 10 years (Article 19).

On a reasoned request, the manufacturer gives an authority the information and documentation in paper or digital format, in a language that authority easily understands (Article 10(10)). How authorities run market surveillance of machinery is explained separately.

Compliance questions about a specific machine go to the national market surveillance authority. The Commission gives generic guidance only.

Compliance Support: Checklist, CE Coordinator and Training

Three pages support the steps above: a dated checklist for the cut-over on 20 January 2027, the role of a CE coordinator or external consultant, and what the Regulation expects of staff training.

From that date, every unit placed on the market or put into service needs the Regulation's declaration, the Annex IV, Part A documentation and the CE marking (Articles 10(2) and 54).

Neither Regulation (EU) 2023/1230 nor Directive 2006/42/EC creates a "CE coordinator" function. Training appears in the Regulation only as information to users: whether particular training is required (Annex III, section 1.1.2(b)(iii)) and instructions for the training of operators where necessary (section 1.7.4.2(1)(k)). Table 3 lists the three support pages.

How Machinery Directive Compliance Differs until 19 January 2027

Under Article 5(1) of Directive 2006/42/EC, which applies until 19 January 2027, the manufacturer ensured compliance with Annex I, kept the technical file of Annex VII Part A available, provided the instructions, applied an Article 12 procedure, drew up the EC declaration of Annex II 1.A and affixed the CE marking under Article 16. The six duties, points (a) to (f), had their procedures in Annexes VIII to X of the Directive, and Annex XII of the Regulation maps Article 5 of the Directive to Articles 10 and 11.

The Regulation changes three of these duties, listed below.

• Risk assessment: the Regulation names only "the manufacturer", where the Directive said "manufacturer or his authorised representative".
• Retention: at least 10 years after placing on the market, instead of at least 10 years from the date of manufacture or the last unit produced.
• Instructions: a language set by the Member State instead of an official Community language, with digital format allowed.

What the Machinery Directive 2006/42/EC required and what replaces it is set out on its own page.

Table 2 sets Article 5(1) of the Directive against Article 10 of the Regulation, point by point.

Products placed on the market in conformity with the Directive before 20 January 2027 may still be made available after that date (Article 52(1) of the Regulation). There is no parallel period in which a manufacturer may choose either act for new units.

Where Machinery Regulation Compliance Stands on 2026-11-12

As of 12 November 2026, Regulation (EU) 2023/1230 is not yet applicable (it applies from 20 January 2027), no harmonised standard is cited in the Official Journal under Regulation (EU) 2023/1230, and the list of standards cited under the Directive is repealed with effect from 20 January 2027 by Article 2 of Implementing Decision (EU) 2026/2015.

That Directive list, Implementing Decision (EU) 2023/1586, was last amended by Implementing Decision (EU) 2026/2015 of 4 September 2026.

Article 50(1) on penalties has applied since 20 October 2026, and Member States had to notify their penalty rules by that date. Penalties are set nationally, must be effective, proportionate and dissuasive, and the Regulation sets no EU fine amount.

EC type-examination certificates and approval decisions issued under the Directive "shall remain valid until they expire" (Article 52(2)). Every date of the Machinery Regulation timeline is listed on its own page.

The Commission proposed in COM(2025) 504 of 21 May 2025 (procedure 2025/0134(COD)) that the EU declaration of conformity be drawn up in digital format, with the product accompanied by its internet address or machine-readable code; the proposal is pending as of 12 November 2026.

Coreper confirmed the text agreed with Parliament negotiators on 26 June 2026, Parliament's IMCO committee approved it on 14 July 2026, and Parliament's first-reading vote is still to come. For the Regulation itself, the Commission's application guide exists as of 12 November 2026 only as a "temporary and partial" publication (version 1.00).

What Machinery Regulation Compliance Does Not Cover

Machinery Regulation compliance as set out above covers machinery and related products placed on the market or put into service from 20 January 2027; partly completed machinery, machines already in service and other EU product laws follow their own rules. The three questions below mark where each of these borders sits.

Does Partly Completed Machinery Follow the Same Steps?

No: partly completed machinery has no Article 25 procedure and no CE marking; its manufacturer draws up the Annex IV Part B documentation and an EU declaration of incorporation (Article 22, Annex V Part B) under Article 11. The final machinery's manufacturer then runs the full steps above. The duties for partly completed machinery are explained in full on its own page.

Do Machines Already in Service Need New Compliance Steps?

No, unless they are substantially modified: products placed on the market under the Directive before 20 January 2027 may still be made available (Article 52(1)), while a substantial modification within Article 3(16) makes the modifier the manufacturer (Article 18). When a change counts as a substantial modification of machinery is set out separately.

The use of machines at work falls under workplace law, covered on Machinery Regulation and the Work Equipment Directive.

Do Other EU Product Laws Add Compliance Steps?

Yes, where another act also applies: one EU declaration of conformity then lists every act with its publication reference (Article 21(3)), and where specific Union legislation covers a risk, the Regulation does not apply to that extent (Article 9). Which acts apply together is set out in the Machinery Regulation and other EU product laws.