Guide
EU Machinery Regulation (EU) 2023/1230: what an importer of machinery from China checks before shipment
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Sinospect witnesses the FAT or inspects the machine before shipment in China and checks the nameplate, the draft declaration, the technical file index and the instructions against the particulars the Regulation requires. Have the CE file checked at FAT →
This guide is for EU buyers of machinery made in China: production lines, presses, packaging and process equipment, machine tools, lifting equipment. It quotes the consolidated text of the Regulation as it stood on 27 July 2026.
When the Machinery Regulation applies
| Date | What happens | Provision |
|---|---|---|
| 19 July 2023 | The Regulation enters into force, on the twentieth day after its publication in the Official Journal | Art. 54 |
| 20 January 2024 | The rules on notifying authorities and notified bodies apply, so conformity assessment bodies can be notified before the Regulation applies | Arts. 26–42; Art. 54(a) |
| 20 January 2027 | The Regulation applies and Directive 2006/42/EC is repealed | Arts. 51(2) and 54 |
| From 20 January 2027 | Machinery placed on the market under the Directive before that date can still be made available; EC type-examination certificates and approval decisions issued under the Directive stay valid until they expire | Art. 52 |
The date that matters for a given machine is the day it is placed on the market: its first making available on the EU market (Article 3(11) and (12)). A machine that passes FAT in December 2026 and is first supplied in the EU in February 2027 needs a file built to the Regulation. For orders delivering around the switchover, have the machine designed to meet both texts, and the declaration issued under whichever one is in force on the day the machine is placed on the market. The Commission’s Blue Guide (section 2.3) explains how that day is set for an imported product.
The Official Journal of 29 June 2023 first printed 14 January 2027. A corrigendum in OJ L 169 of 4 July 2023 corrected the dates to 20 January 2027, and some older summaries still quote the first figure. Two later regulations amend the text and leave the dates as they are: Regulation (EU) 2024/2748 adds emergency procedures for an internal-market crisis, and Regulation (EU) 2026/1744 requires the Commission to add, by delegated acts, requirements for high-risk AI systems in machinery to Annex III, to apply by 2 August 2028.
What changes from the Machinery Directive 2006/42/EC
| Topic | Directive 2006/42/EC | Regulation (EU) 2023/1230 |
|---|---|---|
| Legal form | A directive, transposed into each Member State’s law | A regulation, binding and directly applicable in every Member State (Art. 54) |
| Importers and distributors | Obligations addressed to the manufacturer and its authorised representative | Separate obligations for importers (Arts. 13–14) and distributors (Arts. 15–16) |
| High-risk machinery | Annex IV, 23 categories; internal checks allowed when harmonised standards covered all the requirements | Annex I: Part A, 6 categories, always with a notified body; Part B, 19 categories, module A only with category-specific harmonised standards or common specifications cited under the Regulation and covering all the requirements (Art. 25) |
| Conformity procedures | Internal checks, EC type-examination, full quality assurance | Adds unit verification by a notified body (module G, Annex X) |
| Instructions for use | Supplied with the machine in the official language of the Member State | May be digital on the conditions of Art. 10(7); paper on request at the time of purchase, free, within one month |
| Declaration of conformity | Names the person in the Community authorised to compile the technical file | Model in Annex V, Part A; may be supplied through an internet address or machine-readable code and stays online for at least 10 years (Art. 10(8)) |
| Modification after delivery | No definition of substantial modification | Defined in Art. 3(16); whoever carries it out becomes the manufacturer for that machine (Art. 18) |
| Software and connectivity | Control systems to be safe and reliable | Protection against corruption (Annex III, 1.1.9), control systems resisting malicious attempts and logging safety-software versions (1.2.1), source code of safety software available to authorities on reasoned request (Annex IV, Part A) |
Four categories that sat in the Directive’s Annex IV, where a manufacturer applying harmonised standards could use internal checks, now sit in Part A and always need a notified body: removable mechanical transmission devices, their guards, vehicle servicing lifts and portable cartridge-operated fixing machinery. Part A also adds two new categories for safety functions that rely on machine learning.
Who carries which obligations
| Operator | Who it is | Main obligations |
|---|---|---|
| Manufacturer | Makes the machine, or has it designed or made, and markets it under its own name or trade mark (Art. 3(18)); usually the Chinese factory | Designs and builds to Annex III; draws up the technical documentation (Annex IV, Part A); carries out the conformity assessment (Art. 25); signs the EU declaration of conformity (Art. 21); affixes the CE marking (Art. 24); marks the machine and supplies the instructions; keeps the file for 10 years (Art. 10) |
| Authorised representative | A person established in the EU with a written mandate from the manufacturer (Art. 3(19)); optional | Performs the mandated tasks, at least keeping the declaration and technical documentation at the authorities’ disposal for 10 years, supplying information on request and cooperating with them; the design obligation and drawing up the technical documentation stay with the manufacturer (Art. 12) |
| Importer | A person established in the EU who places a machine from a third country on the EU market (Art. 3(20)) | Places only compliant machinery on the market; checks the conformity assessment, technical documentation, CE marking, documents and markings beforehand; adds its own name and address; ensures the instructions accompany the machine; keeps storage and transport from compromising conformity; keeps a copy of the declaration for 10 years; takes corrective action and informs the authorities when a machine presents a risk (Art. 13) |
| Distributor | Any other person in the supply chain who makes the machine available (Art. 3(21)) | Verifies the CE marking, the declaration, the instructions in the user’s language and the manufacturer’s and importer’s markings before supply; keeps storage and transport from compromising conformity (Art. 15) |
A buyer that imports a machine for use in its own plant runs the same checks: the manufacturer’s obligations apply when a machine is placed on the market or put into service, that is, first used in the EU (Articles 3(13) and 10(1)).
Two rules change these roles. An importer or distributor that places a machine on the market under its own name or trade mark, or modifies one so that compliance might be affected, takes on the manufacturer’s obligations (Article 17): a buyer who has a Chinese factory build a machine under the buyer’s brand is its manufacturer in law. And under Article 4 of the Market Surveillance Regulation (EU) 2019/1020, machinery from a manufacturer outside the EU is placed on the market only with an EU-established operator responsible for the declaration, the documentation and cooperation with the authorities, whose name and contact details appear on the product, its packaging or an accompanying document; for a Chinese manufacturer, that operator is the importer or an authorised representative mandated for those tasks. Article 4(5) of that Regulation names Directive 2006/42/EC; Article 51(2) of the Machinery Regulation reads that reference as one to the Regulation. Every operator must be able to tell the authorities, for 10 years, which economic operators supplied it and which it supplied (Article 19).
What an importer checks before the machine ships
Article 13(2) lists what the importer must make sure of before placing a machine on the market. Each line below is a legal requirement, and most can be checked in China, while the supplier can still correct a gap before shipment.
| Check | What the Regulation requires | Provision |
|---|---|---|
| Conformity assessment | The manufacturer has carried out the procedure that Article 25 sets for the machine’s category: module A, or a notified-body route for Annex I | Arts. 13(2) and 25 |
| Technical documentation | The manufacturer has drawn it up to Annex IV, Part A; the importer ensures it can be made available to the authorities on request for 10 years | Arts. 13(2) and 13(8); Annex IV |
| EU declaration of conformity | Drawn up to Annex V, Part A, and supplied with the machine or through an internet address or code given in the instructions; the importer keeps a copy for 10 years | Arts. 10(8), 13(8) and 21 |
| CE marking | Affixed visibly, legibly and indelibly before the machine is placed on the market, followed by the notified body’s number where one took part | Arts. 13(2) and 24 |
| Identification | Model, series or type; year of construction; serial or batch number | Arts. 10(5) and 13(2) |
| Manufacturer’s details | Name or trade mark, postal address and a website, e-mail or other digital contact, as a single point of contact | Arts. 10(6) and 13(2) |
| Importer’s details | The importer’s name, postal address and digital contact on the machine, or on the packaging or an accompanying document where that is not possible | Art. 13(3) |
| Instructions for use | Supplied with the machine, describing its model, in a language the Member State determines, on paper or digitally on the conditions of Art. 10(7) | Arts. 10(7) and 13(4) |
| Storage and transport | Conditions under the importer’s responsibility keep the machine in conformity | Art. 13(5) |
An importer that has reason to believe a machine does not conform holds it back until it has been brought into conformity, and informs the manufacturer and the market surveillance authorities where it presents a risk (Article 13(2)). The nameplate is where most of these lines meet:
Hydraulic press brake · 160 t · 3 200 mm
- Manufacturer’s registered name · postal address, China · website or e-mail
- ModelPB-160/3200
- Serial no.PB2610-0147
- Year of construction2026
- Importer’s registered name · postal address, EU · website or e-mail
- CE marking
- Instructions for use: scan or visit the address on the plate
- Mass9 800 kg
- Manufacturer Art. 10(6)
- Name or trade mark, postal address and a website, e-mail or other digital contact: one point of contact, matching the declaration of conformity.
- Model, series or type Art. 10(5)
- The designation the declaration, the technical file and the instructions all name.
- Serial or batch number Art. 10(5)
- Read it off the machine at the factory and match it to the declaration and the packing list.
- Year of construction Art. 10(5)
- The year manufacturing was completed, not the year of the order or of shipment.
- Importer Art. 13(3)
- Your company’s name, postal address and digital contact. Send them to the factory before the plate is made.
- CE marking Arts. 23 and 24
- Visible, legible and indelible, affixed before the machine is placed on the market; followed by the notified body’s number where one took part.
- Access to digital instructions Art. 10(7)(a)
- Where the instructions are digital, the machine says how to reach them. Open the link at the factory and download the file.
- Mass and safe-use data Annex III, 1.7.3
- Information essential for safe use, and the mass of any part handled with lifting equipment.
What the EU declaration of conformity contains
Annex V, Part A sets the particulars. Ask the manufacturer for the draft before FAT and compare it with the machine on the day:
- The machine: product, type, model and batch or serial number.
- Name and address of the manufacturer and, where there is one, its authorised representative.
- For lifting machinery that can only be assembled where it is used, the address of that place.
- The statement that the declaration is issued under the manufacturer’s sole responsibility.
- The object of the declaration, identified for traceability; a colour image may be included.
- The Union harmonisation legislation the machine conforms to, in a single declaration covering every act that applies (Art. 21(3)).
- The harmonised standards or common specifications applied, with the date of their reference in the Official Journal, or the other technical specifications with their dates.
- Where applicable, the notified body’s name and number, the procedure it carried out and the certificate reference; or the statement that module A was applied.
- Place and date of issue, and the name, function and signature of the person signing for the manufacturer.
The declaration is kept up to date and translated into the language or languages the Member State requires (Article 21(2)). Partly completed machinery, such as an industrial robot arm for integration into a line, comes with an EU declaration of incorporation (Annex V, Part B) and assembly instructions (Annex XI) instead, and the CE marking goes on the finished machine.
Digital instructions: the conditions
The Regulation allows instructions for use in digital form. When the manufacturer chooses it, Article 10(7) requires:
- A marking on the machine, or on its packaging or an accompanying document where that is not possible, saying how to access the instructions.
- A format the user can print, download and save, so the instructions are available at all times, including during a breakdown; this applies to instructions embedded in the machine’s software too.
- Online access for the machine’s expected lifetime and for at least 10 years after it is placed on the market.
- A paper copy, free of charge, within one month, for a user who asks at the time of purchase.
- For machinery intended for non-professional users, or that they can use under reasonably foreseeable conditions, the safety information essential for putting it into service and using it safely, on paper.
Whatever the format, the instructions describe the model they belong to and are written in a language users can easily understand, as the Member State determines. Maintenance instructions for specialised personnel mandated by the manufacturer or its authorised representative may be in one EU language those personnel understand (Annex III, 1.7.4).
Which machines need a notified body
The route follows the machine’s category in Annex I. Pumps, compressors, conveyors, packaging lines, and CNC machining centres and lathes for metal are not listed in Annex I, and the manufacturer assesses them itself under module A. Numerical control does not take a machine out of Annex I: a press or press brake for the cold working of metals with manual loading or unloading is listed in Part B, CNC or not. The listed categories follow one of two stricter routes:
Art. 25(4)
Not listed in Annex I
For example: pumps, compressors, conveyors, packaging lines, CNC machining centres and lathes for metal
- Procedures the manufacturer may use
- Internal production control (module A)
- Notified body
- None. The manufacturer assesses conformity itself.
- On the machine
- CE marking
Art. 25(3)
Annex I, Part B (19 categories)
Press brakes and presses with manual loading, injection-moulding machines with manual loading, lifts for persons over 3 m, safety logic units
- Procedures the manufacturer may use
- Module A, only where harmonised standards or common specifications specific to the category, cited under the Regulation and covering all the relevant requirements, were applied
- Otherwise: EU type-examination (B) + conformity to type (C), full quality assurance (H) or unit verification (G)
- Notified body
- Takes part in B + C, H and G.
- On the machine
- CE marking, followed by the notified body’s number when one took part
Art. 25(2)
Annex I, Part A (6 categories)
Vehicle servicing lifts, removable mechanical transmission devices and their guards, cartridge-operated fixing machinery, machine-learning safety functions
- Procedures the manufacturer may use
- EU type-examination (B) + conformity to type (C)
- Full quality assurance (H)
- Unit verification (G)
- Notified body
- Always.
- On the machine
- CE marking, followed by the notified body’s number
Annex I, Part A, always with a notified body: removable mechanical transmission devices including their guards; guards for those devices; vehicle servicing lifts; portable cartridge-operated fixing and other impact machinery; safety components with fully or partially self-evolving behaviour using machine-learning approaches that ensure safety functions; and machinery with embedded systems of that kind that were not placed on the market separately, in respect of those systems.
Annex I, Part B: circular saws and band saws for wood or meat of the listed types; hand-fed surface planing machinery, thicknessers with built-in feed and hand-fed vertical spindle moulders for woodworking, and combined machinery of these types and the listed saws; hand-fed tenoning machinery with several tool holders; portable chainsaws for woodworking; presses, including press brakes, for the cold working of metals with manual loading or unloading, a travel above 6 mm and a speed above 30 mm/s; injection or compression moulding machinery for plastics or rubber with manual loading or unloading; underground locomotives, brake-vans and hydraulic roof supports; manually loaded refuse trucks with a compression mechanism; devices for lifting persons with a hazard of falling more than 3 m; protective devices that detect the presence of persons; power-operated interlocking movable guards for those presses and moulding machines; logic units for safety functions; and roll-over and falling-object protective structures (ROPS and FOPS).
For Part B, module A is available only where the machine follows harmonised standards or common specifications specific to its category that cover all the relevant requirements (Article 25(3)); a harmonised standard gives the presumption of conformity once its reference is published in the Official Journal (Article 20(1)). The Regulation has no transitional rule carrying over references published under Directive 2006/42/EC, so before accepting a self-declared press brake or moulding machine, check that the standard is cited under Regulation (EU) 2023/1230.
For a Part A or Part B machine on a notified-body route, look up the body in the Commission’s NANDO database, check that it is notified for that category, and compare the model and the scope on the certificate with the machine on order. An EC type-examination certificate issued under Directive 2006/42/EC stays valid until it expires (Article 52(2)): check its expiry date, and check with the manufacturer how the file covers the Annex III requirements that are new in the Regulation.
Substantial modification
Article 3(16) defines a substantial modification as a change to a machine, by physical or digital means, after it has been placed on the market or put into service, that the manufacturer did not foresee or plan, and that affects safety by creating a new hazard or increasing an existing risk so that it requires either:
- new guards or protective devices whose addition requires a change to the existing safety control system; or
- additional protective measures to ensure the machine’s stability or mechanical strength.
The person who carries out a substantial modification is the manufacturer of that machine for the purposes of the Regulation, with the obligations of Article 10: a conformity assessment under Article 25, a new declaration and the CE marking. Where the change affects only one machine in an assembly, the obligations apply to that machine, as the risk assessment shows (Article 18). A non-professional user modifying a machine for their own use is exempt. Buyers meet this when a line from China is adapted on site: a new guard wired into the safety PLC, a software change to a safety function, a frame reinforced to take a heavier tool. Machines from several suppliers arranged and controlled to work as an integral whole are themselves machinery (Article 3(1)(d)), and whoever assembles them, including for its own use, is the manufacturer of the assembly (Article 3(18)).
The practical answer is to specify EU-market changes before the build, so the manufacturer designs them in and covers them in its own risk assessment and declaration, and to witness them at FAT.
How FAT and pre-shipment inspection verify this in China
A factory acceptance test runs the machine against the contract; a pre-shipment inspection checks the finished, packed goods. Both happen at the factory with the machine and the people who can fix it in the same room, which makes them the place to verify the CE file:
| At the factory | What it verifies | Provision |
|---|---|---|
| Read the nameplate and markings against the machine and the documents | Model, serial number, year of construction, manufacturer’s and importer’s details, CE marking and any notified-body number | Arts. 10(5), 10(6), 13(3) and 24 |
| Compare the draft declaration with Annex V, Part A and with the machine | Model and serial number, legislation listed, standards and their dates, notified body and certificate | Art. 21; Annex V |
| Sight the technical documentation index | Description, risk assessment and list of requirements applied, drawings, standards, test reports, copy of the instructions | Art. 13(2); Annex IV, Part A |
| Look up the notified body and certificate | Body notified for the category; certificate scope and model match the machine | Art. 25 |
| Witness the tests of the safety functions the risk assessment relies on | Emergency stops, interlocked guards, two-hand controls, protective devices and safe stops work as built | Annex III, 1.2.1, 1.2.4 and 1.4 |
| Have the user’s safety-function test run from the draft instructions | The user can test the safety functions, and the instructions describe the specific functional test procedures and any special equipment needed | Annex III, 1.1.2(e) |
| Check the safety software | The machine shows, in an easily accessible form, the installed software it needs to operate safely; software and data critical for compliance are identified and protected against corruption; an intervention in the software or its configuration leaves evidence. Practice: record the version at FAT and confirm it on the shipped machine | Annex III, 1.1.9 |
| Check that software logging is enabled | The control system can keep a tracing log of interventions and of safety-software versions uploaded after placing on the market, for five years after each upload; for self-evolving safety systems, recording of safety decision data is enabled and the data is kept for one year | Annex III, 1.2.1 |
| Check the instructions | Language, model named, digital link opened and file downloaded, paper safety information where required | Arts. 10(7) and 13(4) |
| Check packing and loading | Protection and securing suited to the voyage, so the machine arrives as it was accepted; a legal duty where transport is under the importer’s responsibility | Art. 13(5) |
Procurement practice: contract steps that put these checks on the schedule.
- Write the Regulation into the purchase order: the Annex I category and conformity route, the declaration, access to the technical documentation for 10 years, the language and format of the instructions, and your importer details for the plate.
- Ask for the draft declaration and the technical documentation index two weeks before FAT, and add the CE-file lines to the FAT protocol.
- Agree in writing how the technical documentation reaches an authority on request: from the manufacturer, through an EU authorised representative, or from a copy you hold.
- Treat a missing CE-file item like any open FAT finding: closed and evidenced before the balance is paid and the machine is released.
- Keep the FAT report and nameplate photographs with your copy of the declaration for the same 10 years.
How Sinospect supports this work
Sinospect witnesses factory acceptance tests and carries out pre-shipment inspections at factories in China. For machinery going to the EU, the scope can include the CE-file check on this page: the nameplate and markings, the draft declaration against Annex V, the technical documentation index against Annex IV, the notified-body certificate where Annex I applies, the instructions and their digital access, the safety-software identification and the logging function, and the manufacturer’s tests of the safety functions the risk assessment relies on, which Sinospect witnesses. The report records what was seen, with photographs, what is missing, and which party closes each item before release.
Conformity stays with the manufacturer, which signs the declaration and affixes the CE marking, and with the notified body where Annex I calls for one. The FAT gives the importer dated, photographed evidence from the factory that the nameplate, the declaration and the instructions match the machine it is buying, and a list of what is still open in the file.
Frequently asked questions
When does the EU Machinery Regulation 2023/1230 apply?
From 20 January 2027, the date on which Directive 2006/42/EC is repealed (Articles 51 and 54). Machinery placed on the EU market in conformity with the Directive before that date can still be made available afterwards, and EC type-examination certificates issued under the Directive stay valid until they expire (Article 52). The date that counts for a machine is the day it is first made available on the EU market, so a machine that passes FAT in China in December 2026 and is first supplied in the EU in February 2027 falls under the Regulation.
Is it 14 January or 20 January 2027?
20 January 2027. The Official Journal of 29 June 2023 printed 14 January 2027; a corrigendum published in OJ L 169 on 4 July 2023 corrected that date and the other dates that depended on it. The consolidated text on EUR-Lex reads 20 January 2027, and later amendments in 2024 and 2026 left the date unchanged.
Our Chinese supplier sent a CE certificate. Is the machine compliant?
Look at who issued it and under which procedure. For machinery outside Annex I, the manufacturer declares conformity itself through the EU declaration of conformity and the technical documentation. A “CE certificate” from a testing company that is not a notified body has no legal standing for CE marking; its test reports can go into the technical documentation (Annex IV, Part A). Where Annex I requires a notified body, the evidence is that body’s EU type-examination certificate, quality-system approval decision or unit-verification certificate, or an unexpired EC type-examination certificate issued under the Directive (Article 52(2)): check the body’s number and scope in the Commission’s NANDO database. Either way, the document you keep is the EU declaration of conformity signed by the manufacturer.
Can the instructions for use be supplied only in digital form?
Yes, on the conditions in Article 10(7): the machine, its packaging or an accompanying document says how to reach them; the user can print, download and save them; and they stay online for the machine’s expected lifetime and at least 10 years after it is placed on the market. A user who asks at the time of purchase gets a paper copy free of charge within one month, and machinery intended for non-professional users, or that they can use under reasonably foreseeable conditions, comes with the essential safety information on paper. The instructions are in the language the Member State requires.
The manufacturer has an EU authorised representative. Do we still carry importer duties?
Yes. An authorised representative performs the tasks in its written mandate from the manufacturer, at least keeping the declaration and the technical documentation available to the authorities for 10 years and cooperating with them (Article 12). The importer’s duties in Article 13 are the importer’s own: checking the conformity assessment, the technical documentation, the CE marking and the markings before placing the machine on the market, adding its own name and address, and keeping a copy of the declaration for 10 years.
We plan to add guards or change the safety PLC after delivery. Do we become the manufacturer?
Yes, in two cases. As the importer, you take on the manufacturer’s obligations if you modify the machine in a way that might affect compliance (Article 17). Anyone who makes a substantial modification also becomes the manufacturer: Article 3(16) defines it as a physical or digital change, not foreseen by the manufacturer, that creates a new hazard or increases a risk and needs either new guards or protective devices that require changes to the existing safety control system, or added measures for stability or mechanical strength. Whoever carries it out takes on the manufacturer’s obligations for that machine, including a new conformity assessment and declaration (Article 18). Specifying the change before the build lets the manufacturer include it in its own assessment.
Which machines need a notified body under the Machinery Regulation?
The six categories in Annex I, Part A always do. The nineteen categories in Annex I, Part B need one unless the manufacturer applied harmonised standards or common specifications specific to that category, with references published in the Official Journal under Regulation (EU) 2023/1230, covering all the relevant essential health and safety requirements, in which case internal production control (module A) is available. All other machinery uses module A, with no notified body (Article 25).
Sources
- Regulation (EU) 2023/1230 on machinery, OJ L 165, 29 June 2023, corrected by the corrigendum in OJ L 169, 4 July 2023, p. 35
- Consolidated text of Regulation (EU) 2023/1230, 27 July 2026, including Regulations (EU) 2024/2748 and 2026/1744
- Directive 2006/42/EC on machinery
- Regulation (EU) 2019/1020 on market surveillance, Article 4
- European Commission, machinery sector page
- European Commission, NANDO database of notified bodies
- European Commission, the ‘Blue Guide’ on the implementation of EU product rules 2022, OJ C 247, 29 June 2022, section 2.3
Machinery from China heading for the EU market?
Send the machine type, the factory, the FAT or shipping date and whatever the supplier has sent so far: declaration, certificates, instructions. Sinospect replies with the scope and the fee for a FAT or pre-shipment inspection that includes the CE-file check.