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Article 2 contains specific exclusions, so a product can match part of the machinery concept and still fall outside the Regulation for that reason. The exclusion analysis should be narrow and source-tied, because several exclusions contain exceptions for machinery mounted on excluded transport products.

Common boundary checks include transport products, electrical and electronic products covered by the Low Voltage Directive or Radio Equipment Directive, seagoing vessels and mobile offshore units, research equipment for temporary laboratory use, military or police products, fairground equipment, mine winding gear, and products intended to move performers during artistic performances.

A useful scope record is short but specific. It should identify the item assessed, the intended application, moving parts, drive system or manual lifting-load basis, missing components or software, installation dependency, and whether multiple units are arranged and controlled as an integral whole.

If the answer is not machinery, the record should say whether the product is a related product, partly completed machinery, a safety component, or excluded under a specific Article 2 point. That makes the conclusion reusable for technical documentation, declarations, instructions, supplier reviews, and later design changes.

Review a software update before deployment when it touches software or data that is critical to meeting essential health and safety requirements. Regulation (EU) 2023/1230 expressly treats safety components as physical or digital components, including software, and recognises machinery that is missing only the upload of application-specific software.

Escalate the release if it changes a safety function, safety-related control-system logic, operating parameters, limits generated during a learning phase, remote connectivity, configuration rules, safety logs, or the instructions users rely on to keep the machinery safe throughout its lifetime.

Annex III requires software and data critical for conformity with essential health and safety requirements to be identified and protected against accidental or intentional corruption. It also requires machinery to identify the software needed for safe operation and provide that information in an easily accessible form.

A release process should therefore preserve more than release notes. It should show which safety software changed, who authorised it, how corruption protection was tested, and whether the machinery collects evidence of legitimate or illegitimate intervention in relevant hardware, software, or configuration.

The Regulation defines substantial modification as a post-market or post-service modification by physical or digital means that was not foreseen or planned by the manufacturer, affects safety by creating a new hazard or increasing an existing risk, and requires specified protective changes. Software updates should be screened against that definition before release to customers or fielded equipment.

Even when the update does not meet the substantial-modification threshold, the manufacturer still needs procedures so series production remains in conformity and must account for changes in design, characteristics, harmonised standards, technical specifications, or common specifications used to declare conformity.

Software updates can make existing instructions wrong. Article 10 and Annex III require instructions to describe the corresponding product model, intended use, precautions, safe installation and use, residual risks, protective measures, maintenance, breakdown response, and other safety information. Digital instructions are allowed, but access, download, print, lifetime availability, and paper-on-request requirements still matter.

Keep the CE file aligned with the release. Technical documentation should make conformity assessable and include an adequate risk analysis and assessment; manufacturers must keep technical documentation and the EU declaration of conformity available to market surveillance authorities for at least 10 years after placing on the market or putting into service. Where relevant and necessary for checking Annex III compliance, source code or programming logic included in technical documentation must be made available to competent national authorities on reasoned request.

Start with the market boundary. Regulation (EU) 2023/1230 defines placing on the market as the first making available of an in-scope product on the Union market, and putting into service as the first use in the Union for its intended purpose. A second-hand machine that was already lawfully placed on the EU market is not automatically treated as newly placed on the market just because it is sold again.

The answer changes when the machine is first brought into EU use after being used outside the EU, or when a later modification crosses the substantial-modification test. In those cases, the team should treat the event as a conformity trigger instead of relying on the old declaration, old technical file, or a resale record alone.

Apply the substantial-modification test in sequence. The modification must occur after placing on the market or putting into service; be physical or digital; be outside what the manufacturer foresaw or planned; affect safety by creating a new hazard or increasing an existing risk; and require either guards or protective devices that change the existing safety control system, or additional protective measures for stability or mechanical strength.

Repairs and maintenance that do not affect compliance with the essential health and safety requirements should not be treated as substantial modifications. Planned manufacturer updates are also different from an unplanned third-party modification because the definition requires the change not to be foreseen or planned by the manufacturer.

If the event is first EU placing on the market, first EU putting into service, or a substantial modification by a professional operator, the responsible person cannot simply annotate the old file. For machinery and related products, Article 10 requires design and construction in line with Annex III, technical documentation under Annex IV Part A, the relevant Article 25 conformity assessment procedure, an EU declaration of conformity, CE marking, instructions, and retention of the technical documentation and declaration for market surveillance authorities.

For partly completed machinery, the evidence route is different: Article 11 points to Annex IV Part B technical documentation, an EU declaration of incorporation, and assembly instructions. Do not replace that with a machinery declaration unless the product has become complete machinery or a related product.

The record should let a market surveillance authority or decision owner see why the machine was treated as resale, first EU use, ordinary repair, planned update, or substantial modification. The evidence should not be a generic compliance statement; it should tie the actual modification to the legal test and the updated risk assessment.

Regulation (EU) 2023/1230 requires manufacturers to keep technical documentation and declarations available to market surveillance authorities for at least 10 years after machinery is placed on the market or put into service. Regulation (EU) 2019/1020 gives market surveillance authorities powers to require corrective action and, where risks persist, restrict, withdraw, or recall products.

Most errors come from skipping the boundary question. A team treats a used machine as automatically exempt, or treats every repair as a new machine, without documenting first EU use, the manufacturer's planned configuration, and whether the modification actually creates a new hazard or increases an existing risk.

The other frequent problem is evidence drift: the old declaration, old test report, or supplier file may still matter, but it does not prove the modified configuration unless the changed hazards, safety functions, instructions, and conformity route have been reassessed.

Start with Annex I. Part A covers categories that must use one of the third-party routes in Article 25(2): EU type-examination followed by conformity to type, full quality assurance, or unit verification. Those routes involve a notified body.

Part B gives manufacturers more room, but not always a self-assessment route. Article 25(3) allows internal production control only when the machinery or related product is designed and constructed in accordance with harmonised standards or common specifications specific to that category and covering all relevant essential health and safety requirements. If that coverage is missing or only partial, the manufacturer must use EU type-examination, full quality assurance, or unit verification.

If the product is not listed in Annex I, Article 25(4) points to internal production control. A notified body may still be useful commercially or technically, but the Regulation route itself is not the reason unless another applicable EU act requires it.

Use the EU Single Market Compliance Space notified-bodies search by legislation. Select Regulation (EU) 2023/1230 on machinery, then check bodies notified for the legislation and the relevant conformity-assessment activity before approaching one.

Do not treat a general certificate, test lab report, or consultant statement as a notified-body approval. The body should be notified for the machinery legislation and the assessment route you need, and its identification number should match the body named in the certificate, quality-system decision, unit-verification certificate, or EU declaration entry.

Keep a dated lookup record because notification scope can change. If a notified body is suspended, restricted, withdrawn, or ceases activity, the Regulation assigns follow-up handling to notifying authorities, but the manufacturer still needs a usable conformity record for the product.

Under Module B, the notified body examines the technical design, reviews technical documentation, checks representative specimens where required, and issues or refuses an EU type-examination certificate. The manufacturer then uses Module C to keep production in conformity with the approved type.

Under Module H, the notified body assesses the manufacturer's quality system, including design controls, product quality responsibilities, examinations, tests, records, and monitoring. It also performs surveillance through audits and may make unexpected visits.

Under Module G, the notified body examines and tests the individual machinery or related product, or has tests carried out, and issues a certificate for the examinations and tests performed. This is not a blanket approval for future variants.

A notified-body certificate is not the whole compliance file. The manufacturer must still demonstrate that the product meets the applicable essential health and safety requirements in Annex III, draw up technical documentation, issue the EU declaration of conformity, affix the CE marking, and keep required records available for market surveillance.

Technical documentation should show the intended use, risk assessment, applicable EHSRs, protective measures, residual risks, drawings, standards or common specifications applied, other technical specifications used for uncovered requirements, test and inspection results, and production controls.

Changes matter after the first assessment. The manufacturer must account for changes in design, production, characteristics, harmonised standards, technical specifications, or common specifications. For Module B, modifications affecting conformity or certificate validity require additional notified-body approval.

Article 25 does not ask teams to choose a module by preference. It first separates machinery and related products into Annex I Part A, Annex I Part B, or not listed in Annex I, then limits the available conformity assessment procedures for that route.

For Annex I Part A, the available procedures are EU type-examination under Module B followed by conformity to type based on internal production control under Module C, full quality assurance under Module H, or unit verification under Module G. Module A alone is not available for Part A categories.

For Annex I Part B, Module A is available only if the manufacturer designs and constructs the product in accordance with harmonised standards or common specifications specific to that category and covering all relevant essential health and safety requirements. If that condition is not met, the manufacturer must use Module B plus C, Module H, or Module G.

Annex I Part A contains the categories that trigger Article 25(2), including removable mechanical transmission devices and their guards, vehicle servicing lifts, portable cartridge-operated fixing and other impact machinery, certain machine-learning safety components, and machinery with embedded self-evolving machine-learning systems ensuring safety functions in respect of those systems.

Annex I Part B contains categories that trigger Article 25(3). The practical difference is that Part B can still use Module A when the relevant harmonised standards or common specifications fully cover the applicable EHSRs for the category. If the product departs from that coverage, uses only partial coverage, or relies on other technical specifications for relevant requirements, the Article 25 route shifts to a notified-body route.

In Module B, the notified body examines the technical design, reviews the technical documentation, examines a representative specimen, checks use of harmonised standards or common specifications, and issues or refuses an EU type-examination certificate. Module C is then the manufacturer's production-control step against that approved type.

In Module H, the notified body assesses and approves the manufacturer's quality system, monitors it through surveillance, and its identification number accompanies the CE marking under that module. In Module G, the notified body carries out or has carried out examinations and tests for the individual unit and issues a certificate for those examinations and tests.

Use the notified-body database to confirm that the body is notified for the relevant machinery legislation and scope. A voluntary certificate from a body acting outside its notified scope is not a substitute for the Article 25 procedure.

The technical documentation should make the Article 25 route auditable. It should show the intended use, applicable EHSRs, risk assessment, protective measures, residual risks where relevant, drawings and schemes, standards or common specifications applied, other technical specifications used where standards are not fully applied, and reports or results from calculations, tests, inspections, and examinations.

The evidence set should also connect the selected module to the declaration and marking package. For Module A, that means the technical documentation, production-control evidence, CE marking, and EU declaration of conformity. For notified-body routes, add the relevant certificates, approvals, reports, and notified-body identification-number evidence required by the chosen module.