Conformity Assessment under the Machinery Regulation: Modules A, B+C, H and G and When a Notified Body Is Needed

The answer turns first on whether the product is listed in Annex I of the Regulation, which holds 6 Part A categories and 19 Part B points.

Article 25 applies to products placed on the market or put into service from 20 January 2027, when the Regulation becomes directly applicable; until 19 January 2027, Article 12 of Directive 2006/42/EC governs the procedure through national transpositions. How the rest of the EU Machinery Regulation fits together is explained on the home page.

The sections below cover the three routes, the five modules, the notified-body question, the Directive comparison and the status as of 12 November 2026.

What Is Conformity Assessment under the Machinery Regulation?

Conformity assessment under the Machinery Regulation is, in the words of Article 3(28) of Regulation (EU) 2023/1230, "the process for demonstrating whether the applicable essential health and safety requirements in this Regulation relating to machinery or related products have been fulfilled".

The essential health and safety requirements sit in Annex III of Regulation (EU) 2023/1230, so the procedure measures the product against Annex III.

Article 10(2) of Regulation (EU) 2023/1230 fixes the order of the manufacturer's steps before a product is placed on the market. The four steps run in the order listed below.

1. Draw up the technical documentation set out in Annex IV, Part A.
2. Carry out the applicable conformity assessment procedure under Article 25.
3. Draw up the EU declaration of conformity under Article 21 and Annex V, Part A.
4. Affix the CE marking under Article 24.

The procedure is one step of compliance, followed by retention: the manufacturer keeps the technical documentation, the EU declaration of conformity and any certificate for at least 10 years after placing on the market or putting into service (Article 10(3)). Every other step of Machinery Regulation compliance is set out on its own page.

Who Applies the Procedure: Manufacturer, Modifier and Notified Body

Article 25(1) of Regulation (EU) 2023/1230 gives the procedure to the manufacturer, or to the person who substantially modifies machinery and so becomes its manufacturer under Article 18. That person applies one of the routes that Article 25 allows for the product class and stays responsible for the result.

The authorised representative has a narrower role. Article 12(1), second subparagraph, of the Regulation keeps the Article 10(1) and 11(1) obligations and drawing up the Annex IV technical documentation out of its mandate, so the authorised representative does not apply the procedure.

Under module A it may carry out the Annex VI point 4 tasks, the CE marking and the EU declaration of conformity, where the mandate specifies them (Annex VI point 5).

The notified body examines the type under module B, approves and surveils the quality system under module H, or verifies each unit under module G; it never takes over the manufacturer's responsibility.

Conformity Assessment Routes by Product Class (Article 25)

Article 25 of Regulation (EU) 2023/1230 sets one route per product class: products not listed in Annex I use 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 category-specific harmonised standards or common specifications covering all relevant requirements, otherwise B+C, H or G.

Annex I of the Regulation lists 6 Part A categories and 19 Part B points, 25 in total, unchanged since adoption. Each of the Annex I high-risk machinery categories is described on its own page.

Table 1 sets the route for each product class next to its legal basis in Regulation (EU) 2023/1230.

Products Not Listed in Annex I: Internal Production Control Only

Machinery and related products that are not listed in Annex I follow internal production control (module A, Annex VI) and no other procedure (Article 25(4) of Regulation (EU) 2023/1230).

Module A involves no notified body and produces no certificate. The manufacturer ensures that production conforms to the technical documentation, draws up the EU declaration of conformity and affixes the CE marking to each individual product (Annex VI point 4.1).

A manufacturer of a product outside Annex I cannot move to module B+C, H or G: Article 25(4) names internal production control as the single procedure.

Annex I, Part A Products: A Notified Body in Every Route

Annex I, Part A products follow EU type-examination with conformity to type (modules B and C, Annexes VII and VIII), full quality assurance (module H, Annex IX) or unit verification (module G, Annex X), and never module A (Article 25(2) of Regulation (EU) 2023/1230). A notified body therefore takes part in every Part A assessment.

Part A points 1 to 4 were points 14, 15, 16 and 18 of Annex IV of Directive 2006/42/EC. Points 5 and 6 are new: safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions, and machinery with embedded systems of that kind, in respect of those systems only.

Under the Directive, the four older categories could use internal checks when built to harmonised standards covering all relevant requirements; under the Regulation, they always need a notified body, and the six Annex I Part A categories are listed separately.

AI systems acting as safety components are also high-risk under Regulation (EU) 2024/1689.

Annex I, Part B Products: Module A Only with Category-Specific Standards

Annex I, Part B products may use internal production control only if the manufacturer designs and constructs them "in accordance with the harmonised standards or common specifications specific to that category of machinery or related product covering all the relevant essential health and safety requirements" (Article 25(3), second subparagraph, of Regulation (EU) 2023/1230). Both elements of the condition must be met at once.

Without that full coverage, the manufacturer of a Part B product follows the same three notified-body routes as for Part A: module B+C, module H or module G. A standard that covers only part of the relevant requirements does not open module A. The 19 Annex I Part B categories and their standards are listed separately.

Applying the condition to one product means checking three things: the Annex I point, the standards or common specifications used, and their coverage of Annex III. The route finder below gives an indicative result with the legal basis for each answer.

Modules A, B+C, H and G Compared

The Machinery Regulation uses five of the sixteen modules of Decision No 768/2008/EC: internal production control (A, Annex VI), EU type-examination (B, Annex VII) followed by conformity to type (C, Annex VIII), full quality assurance (H, Annex IX) and unit verification (G, Annex X).

Annex II of Decision No 768/2008/EC holds the full module catalogue; the four routes built from the five modules test different things, as listed below.

• Module A (Annex VI): the manufacturer alone ensures and declares conformity.
• Module B (Annex VII) with module C (Annex VIII): a notified body chosen by the manufacturer examines the technical documentation and a specimen representative of production; under module C no notified body takes part in production.
• Module H (Annex IX): a notified body assesses and surveils the quality system; the audit team includes an assessor experienced in the machinery field (Annex IX point 3.3).
• Module G (Annex X): a notified body examines and tests each unit and issues a certificate (Annex X point 4).

Whatever the module, the route ends with the manufacturer drawing up the EU declaration of conformity.

Table 2 maps each module to its annex, its Directive counterpart and the notified body's role.

EU type-examination certificates are valid for at most five years, whether new or renewed (Annex VII point 6.1 of Regulation (EU) 2023/1230). EC type-examination certificates and approval decisions issued under Article 12 of the Directive "shall remain valid until they expire" (Article 52(2) of the Regulation, which has applied since 19 July 2023).

When Does Machinery Need a Notified Body?

Machinery needs a notified body when it is listed in Annex I, Part A, always, or in Annex I, Part B, unless the manufacturer uses module A under the category-specific standards condition of Article 25(3); machinery not listed in Annex I never needs one for conformity assessment (Article 25(4)).

A notified body is "a conformity assessment body notified in accordance with this Regulation" (Article 3(30) of Regulation (EU) 2023/1230). Chapter V of the Regulation (Articles 26 to 42) has applied since 20 January 2024, so bodies could be notified before the general application date. Four rules govern their work.

• Fees: bodies take into account the specific interests and needs of SMEs when setting fees (Article 25(5)); about 98 % of machinery companies are SMEs (recital 27).
• Proportionality: bodies act proportionately to the undertaking's size, sector and structure, the technology's complexity and serial production (Article 38(2)).
• Independence: the remuneration of a body's staff does not depend on the number or the results of the assessments carried out (Article 30(8)).
• Appeals: bodies run a transparent and accessible appeals procedure (Article 39).

As of 12 November 2026, NANDO lists 36 active notifications under Regulation (EU) 2023/1230 and 79 under Directive 2006/42/EC. A body must be notified for the module and the Annex I category concerned.

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

Table 3 points to the two topics that follow from the notified-body answer.

Conformity Assessment under the Machinery Directive: Article 12 Compared

Under Article 12 of Directive 2006/42/EC, which applies until 19 January 2027, machinery not in Annex IV used internal checks (Annex VIII), and Annex IV machinery built to harmonised standards covering all relevant requirements could choose internal checks, EC type-examination (Annex IX with Annex VIII point 3) or full quality assurance (Annex X) (Article 12(3)); without such standards only the last two remained (Article 12(4)).

The Regulation changes the Directive's procedure in three ways, listed below.

1. Self-certification ends for four categories: former Annex IV points 14, 15, 16 and 18 are now Annex I Part A points 1 to 4 and always need a notified body.
2. Module G is new: the Directive had no unit verification.
3. The authorised representative drops out: under Article 12(1) of the Directive, "the manufacturer or his authorised representative" applied the procedure; under Article 25(1) of the Regulation it is the manufacturer or the Article 18 modifier.

Annex XII of the Regulation is the correlation table with the Directive, and the full list of Machinery Directive to Machinery Regulation changes sits on its own page.

The Commission's impact assessment of 21 April 2021 (SWD(2021) 82) estimated how assessments split under the Directive. About 80 % were self-assessments of machinery outside Annex IV, 10 % self-assessments of Annex IV machinery, 8 % EC type-examinations and 2 % full quality assurance. These are 2021 estimates, not current figures.

Table 4 compares the two acts point by point. Directive 2006/42/EC applies until 19 January 2027, Regulation (EU) 2023/1230 from 20 January 2027.

Where Conformity Assessment Stands on 2026-11-12

As of 12 November 2026, Article 25 of Regulation (EU) 2023/1230 is not yet applicable (it applies from 20 January 2027), notified bodies can already be notified under it, and no harmonised standard is cited in the Official Journal under Regulation (EU) 2023/1230.

Until 19 January 2027, the references listed under the Directive give presumption of conformity. The Directive list, Implementing Decision (EU) 2023/1586, was last amended by Implementing Decision (EU) 2026/2015 of 4 September 2026, which also repeals it with effect from 20 January 2027 (Article 2). What each harmonised standard for machinery covers is set out on the standards page.

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), with no parallel period. The Commission proposed COM(2025) 504 on 21 May 2025 (procedure 2025/0134(COD)), and it 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. Regulation (EU) 2024/2748 and Article 3 of Regulation (EU) 2026/1744 amend the Regulation, but neither amends Article 25.

What Conformity Assessment Does Not Cover

Conformity assessment under Article 25 covers finished machinery and related products; it does not apply to partly completed machinery, and it does not replace the manufacturer's own risk assessment or technical documentation.

The emergency procedures of Chapter IVa (Articles 25a to 25e, inserted by Regulation (EU) 2024/2748), which have applied since 29 May 2026, work only after a Commission implementing act under Article 28 of Regulation (EU) 2024/2747 and an activated internal market emergency mode, and products authorised under Article 25c "shall not bear the CE marking". The crisis route is covered under Machinery Regulation amendments.

Does Partly Completed Machinery Go Through Conformity Assessment?

No: partly completed machinery has no Article 25 procedure; its manufacturer draws up the Annex IV Part B documentation and an EU declaration of incorporation (Annex V Part B) under Article 11 of Regulation (EU) 2023/1230, and it bears no CE marking. Annex IV, Part A, point (j) then places the declaration of incorporation and the assembly instructions in the final machinery's technical documentation where appropriate. The duties for partly completed machinery are explained in full on their own page.

Does a Modified Machine Need a New Conformity Assessment?

Yes, if the modification is substantial: the person who makes it becomes the manufacturer under Article 18 and applies Article 25(2), (3) or (4) again, while a non-professional user modifying a machine for own use does not. The modifier takes on the Article 10 obligations. When a change counts as a substantial modification of machinery is set out separately.