EU Machinery Regulation

Complete risk assessment and risk reduction at design and construction stage. Beyond conventional mechanical hazards it must cover lifecycle hazards that are foreseeable at the time of placing on the market as an intended evolution of fully or partially self-evolving behaviour or logic, and risks arising from interactions between machines arranged to function as an integral whole. The human-machine interface must be adapted to the foreseeable characteristics of operators and the machine must communicate its planned actions in a comprehensible manner.

Applies when

All manufacturers placing machinery or related products on the EU market or putting them into service, and anyone treated as manufacturer under Article 18 for substantial modifications.

Applies from: 2027-01-20

Evidence to retain

• · Risk assessment report with hazard list, risk matrix and residual risk statement
• · Documented boundaries and limiting measures for the intended evolution of self-evolving or autonomous functions
• · Definition of machine-to-machine interactions and of the assembly boundary
• · Human-machine interface design rationale showing adaptation to operator characteristics
• · Verification and validation test records for the risk reduction measures

Estimated first-time effort: 20–60 person-days (estimate, not a commitment)

Items 5 and 6 of Annex I Part A — safety components with fully or partially self-evolving behaviour using machine learning that ensure safety functions, and machinery embedding such systems that have not been placed independently on the market, in respect only of those systems — cannot be self-declared. One of the three Article 25(2) procedures must be used: module B EU type-examination plus module C, module H full quality assurance, or module G unit verification.

Applies when

Manufacturers of robots, AGV/AMR and cobots, and suppliers of safety components, where a safety function (emergency stop, safe limited speed, safe monitored stop, personnel detection) is implemented or co-implemented by a machine-learning model. Where the safety component was already placed independently on the market with third-party assessment, the machine need not be re-certified merely because it embeds that system.

Applies from: 2027-01-20

Evidence to retain

• · Inventory of safety functions and the documented determination of whether machine-learning self-evolving behaviour is used
• · Rationale for the conformity assessment module chosen and record of notified body selection
• · EU type-examination certificate (module B), approved full quality assurance system (module H) or unit verification certificate (module G)
• · Notified body findings and closure records

Estimated first-time effort: 40–120 person-days (estimate, not a commitment)

Draw up the technical documentation set out in Annex IV Part A before placing on the market. Technical documentation and the EU declaration of conformity must be available to market surveillance authorities for at least 10 years from placing on the market or putting into service. Where the source code or programming logic contained in the technical documentation is necessary to check compliance with the Annex III essential requirements, it must be made available upon a reasoned request.

Applies when

All manufacturers and anyone treated as manufacturer for substantial modifications; importers must verify that the manufacturer has drawn up the technical documentation and can produce it for 10 years.

Applies from: 2027-01-20

Evidence to retain

• · Complete Annex IV Part A technical file (general drawings, control circuit diagrams, calculations and test results)
• · List of harmonised standards applied, with clause-level identification where only partly applied
• · Configuration management records for software and model versions
• · Escrow and controlled-disclosure procedure for source code / programming logic, including confidentiality arrangements
• · Named custodian and storage location for the 10-year retention

Estimated first-time effort: 15–45 person-days (estimate, not a commitment)

After conformity assessment, draw up the EU declaration of conformity under Article 21 and Annex V Part A and affix the CE marking under Articles 23 and 24. The machinery must be accompanied by the declaration, or the instructions must give the internet address or machine-readable code where it can be accessed. A digital declaration must stay accessible online for the expected lifetime and in any event for at least 10 years from placing on the market or putting into service.

Applies when

Manufacturers; authorised representatives keep the declaration within their mandate; importers and distributors must check that the CE marking and accompanying documents are present.

Applies from: 2027-01-20

Evidence to retain

• · EU declaration of conformity in the Annex V Part A format, citing the Regulation and the notified body number
• · Check record for CE marking placement and visibility
• · Hosting page and availability monitoring record for the digital declaration
• · Authorisation of the signatory of the declaration

Estimated first-time effort: 3–10 person-days (estimate, not a commitment)

Products within the scope are subject to Regulation (EU) 2019/1020, so they may only be placed on the market if an economic operator established in the Union is responsible for the tasks in Article 4(3) of that Regulation. Non-EU manufacturers should appoint an authorised representative by written mandate under Article 12 to keep the declaration of conformity and technical documentation and cooperate with authorities. The manufacturer must state its name and a contactable postal address and digital contact on the product, its packaging or an accompanying document.

Applies when

Chinese robot and machinery manufacturers without an EU legal entity, and EU distributors acting as importers.

Applies from: 2027-01-20

Evidence to retain

• · Written mandate of the authorised representative specifying the tasks covered
• · Identity and address of the EU responsible economic operator and a proof of its marking on the product or packaging
• · Arrangement making the technical documentation and declaration retrievable inside the EU
• · Named contact and response procedure for market surveillance authorities

Estimated first-time effort: 5–15 person-days (estimate, not a commitment)

Machinery must be accompanied by the instructions and information set out in Annex III. Digital instructions are allowed only if: the means of access is marked on the product, packaging or an accompanying document; the format lets the user print, download and store them on a device (including where they are embedded in the machine software); and they stay online for the expected lifetime and at least 10 years after placing on the market. On request at the time of purchase the manufacturer must supply paper instructions free of charge within one month, and machinery intended for or foreseeably used by non-professional users must carry essential safety information on paper. The language must be one easily understood by users as determined by the Member State concerned.

Applies when

All manufacturers supplying machinery to the EU, particularly smart robot products that deliver their manual through an app or the cloud.

Applies from: 2027-01-20

Evidence to retain

• · Final instructions and safety information in each required language
• · Proof that the access mark (QR code / URL) for digital instructions is applied on the product
• · Hosting evidence that digital instructions are printable, downloadable and available online for 10 years
• · Process and ticket records for supplying paper instructions on request within one month

Estimated first-time effort: 8–25 person-days (estimate, not a commitment)

A natural or legal person carrying out a substantial modification is deemed to be the manufacturer and takes on all Article 10 obligations, must declare conformity on its sole responsibility for the affected machinery and must reapply the relevant conformity assessment procedure under Article 25(2), (3) or (4). Companies need a documented test for which remote updates, added functions or safety-related model replacements amount to a substantial modification. A non-professional user modifying their own machinery for their own use is not deemed the manufacturer.

Applies when

Chinese robot vendors and system integrators that deliver OTA upgrades, feature subscriptions, retraining of safety-related models or line retrofits for EU customers, and EU-side integrators performing the modification.

Applies from: 2027-01-20

Evidence to retain

• · Change classification criteria and the per-change determination of whether a substantial modification occurs
• · Re-run risk assessment and delta analysis for the affected machinery
• · Post-modification conformity assessment records and the new EU declaration of conformity
• · Customer notification and on-site acceptance records

Estimated first-time effort: 10–30 person-days (estimate, not a commitment)