Resources · EU Machinery Regulation
EU Machinery Regulation 2027 for manufacturers: organise requirements, evidence and release
Manufacturers carry the main responsibility for the machinery conformity process. The work is easier to manage when it follows a clear chain: define the product, assess risks, meet the applicable requirements, maintain technical documentation and close the release with evidence.
Regulation (EU) 2023/1230 generally applies from 20 January 2027. If you are developing, integrating or modifying machinery now, it is worth checking which processes and documents need to change.
Follow the work from product definition to risk assessment, technical documents and a recorded release decision. You can see which evidence is available and where further work is needed. The guidance does not replace a product-specific conformity assessment.
On this page
When are you a manufacturer?
You do not have to make every component yourself to act as the manufacturer.
The role can apply if your company has machinery designed or manufactured and places it on the market under its own name or trade mark. It can also be relevant when machinery is put into service for your own use.
An importer or distributor can acquire manufacturer obligations through own branding or certain modifications. A substantial modification may also create manufacturer responsibilities for the person carrying it out.
That is why the role should be checked again after integration, retrofit, rebranding or significant changes.
Useful question: Who is responsible for the design, conformity assessment and final release of this exact product and configuration?
Which tasks remain with the manufacturer?
For machinery and related products, the Regulation requires design and construction in line with the applicable essential health and safety requirements in Annex III.
The manufacturer process generally includes:
- preparing and maintaining technical documentation under Annex IV, Part A;
- carrying out or arranging the applicable conformity assessment;
- drawing up the EU declaration of conformity;
- affixing CE marking where required;
- providing product and manufacturer identification;
- supplying the required instructions for use and other information;
- keeping required documents available for the prescribed period, generally at least ten years.
Partly completed machinery follows a different route. Relevant outputs include technical documentation under Annex IV, Part B, assembly instructions and an EU declaration of incorporation.
Start by distinguishing these product paths. They are not interchangeable.
A practical workflow for manufacturers
Define the product and configuration
What exactly is being assessed? Record the machine, model, variants, software version and intended use. Is it machinery, a related product or partly completed machinery?
A clear product scope prevents evidence for different configurations from being mixed together.
Check the application date and legal context
When will the product first be placed on the market or put into service? Does the project extend beyond 20 January 2027?
Review the differences between the existing Machinery Directive process and the new Regulation. Reuse suitable work, but identify what needs updating.
Perform the risk assessment and address requirements
Identify hazards, assess risks and determine the required protective measures. Connect the relevant Annex III requirements to the actual machine.
The result should show more than a list. It should explain the hazard, chosen measure and supporting verification or validation evidence.
Build and control technical documentation
Bring design information, calculations, risk assessment, standards, test results, supplier evidence and conformity decisions into a coherent technical record.
Keep track of product versions and document status. It is much easier to manage evidence throughout development than to recreate the file shortly before delivery.
Select the conformity assessment route
The correct procedure depends on the product and its classification, including the categories and conditions in Annex I.
Do not assume one route fits every machine. Decide and document the relevant procedure early.
Prepare declarations, markings and user information
After the required assessment, complete the EU declaration of conformity and CE marking where applicable. Confirm manufacturer and product identification. Release the instructions for use in the form and languages required for the destination market.
Close the evidence and release decision
Before release, check whether all required reviews and records are complete. Link remaining issues to owners and decisions. A release record should identify the product version, evidence set and approving responsibility.
Risk assessment and Annex III
Annex III contains the Regulation's essential health and safety requirements. They need to be considered in relation to the actual machine and its intended conditions of use.
A useful evidence chain is:
Hazard → applicable requirement → protective measure → verification or validation evidence.
This makes design decisions easier to explain and review. It also helps when a machine changes later.
Technical documentation is a controlled record
A technical file is not simply a folder assembled at the end of a project.
A well-managed record should answer:
- Which product and configuration does it cover?
- Which risk assessment is current?
- Which supplier documents support the design?
- Which tests or calculations demonstrate the relevant measures?
- Which standards and technical specifications were applied?
- Which issues remain open?
A technical-documentation index makes the relationships visible. It shows document versions, responsible owners and missing evidence.
Digital instructions for use
The Regulation permits digital instructions under specified conditions.
That raises practical questions. Can users access, download, save and print the instructions? Are they clearly linked to the relevant model? Will they remain available for the required period? How will a paper version be handled when requested under the Regulation?
Choose the delivery format as part of the product documentation and release process, not as a last-minute publishing decision.
Partly completed machinery and integration
Partly completed machinery has its own manufacturer route. The future integrator needs information that helps complete the conformity work for the final machine.
Useful questions include:
- Which essential health and safety requirements have been applied and fulfilled?
- Is the Annex IV, Part B technical documentation available?
- Are assembly instructions complete and usable?
- Has the EU declaration of incorporation been prepared?
- Which interfaces, limitations and remaining hazards need to be communicated?
Clear handover records reduce late surprises during system integration.
Retrofit, modification and substantial modification
A machine modification needs both a technical and a regulatory review.
The key question is whether the change affects conformity or creates a substantial modification under the Regulation. If it does, the person carrying out that modification may assume manufacturer obligations for the affected machinery.
Use a controlled change path:
- Describe the original machine and proposed change.
- Review hazards, protective measures and performance impacts.
- Determine whether new manufacturer obligations arise.
- Identify the applicable assessment and documentation work.
- Update the evidence and release the revised configuration.
This keeps modification work connected to the conformity record.
Software, connected functions and protection against corruption
Safety-related software and connected functions can be affected by incorrect changes, manipulation or digital attacks. The Regulation addresses certain risks involving the corruption of safety-related controls and information.
For a connected or software-dependent machine, consider:
- Which software and parameter versions are part of the released configuration?
- Which connections or remote-access paths exist?
- How are safety-related settings protected?
- What evidence is needed from component and software suppliers?
- How are updates and changes assessed for safety impact?
Treat these questions as part of machinery safety and its risk assessment. They are not automatically the same as general IT security compliance.
Supplier information and external evidence
Manufacturers often rely on suppliers for components, assemblies, software and test evidence.
Define the required information early. State which product version it must describe, who checks it and what happens when it is missing.
A broad claim such as “CE compliant” does not establish the conformity of your completed machine. The manufacturer's own assessment remains necessary.
What happens after placing on the market?
Some responsibilities continue after release.
Depending on risks and circumstances, manufacturers may need sampling checks, complaint monitoring, corrective action and, where necessary, withdrawal or recall. Authority notifications can also be required when a product presents a risk.
Define who receives reports, assesses them and decides the next step. This makes later issues easier to control.
Issues worth checking early
- Product scope and configuration are not clearly defined.
- Risk assessment and technical documentation are managed separately.
- Supplier evidence is requested only just before shipment.
- The conformity assessment route is decided too late.
- Software versions and changes are missing from the released record.
- Partly completed machinery arrives without clear integration information.
- CE marking or the declaration is treated as a formality while evidence remains open.
- Release approval does not point to the supporting documents.
Four questions for the manufacturer role
These questions help you reuse existing CE work, identify gaps and keep an evidence trail linked to the actual machine.
What applies to our machine?
Clarify the product path, date, role, configuration and conformity assessment procedure.
What needs to be completed?
Organise the risk assessment, applicable requirements, technical documentation, conformity assessment, instructions, declarations and markings.
How should we complete the work?
Use clear work steps, ownership, supplier requests, reviews and controlled handovers.
How do we show completion?
Keep versioned documentation, test evidence, approvals and an explicit record of the final conformity and release decision.
Practice Kit for manufacturers
SP Services is developing an English-language Manufacturer Practice Kit with a prepared workflow, practical working documents, and evidence and release records. Your team can work with the actual machine and existing project information instead of building every checklist and documentation structure from scratch.
The aim is to make gaps, decisions and supporting records easier to follow. Product-specific technical judgement and conformity assessment remain with the responsible parties.
Individual support
Complex machines, integration projects, modifications and difficult supplier interfaces sometimes need individual technical support.
SP Services can support process structure, evidence planning, supplier requirements and project coordination, within an agreed scope.
Frequently asked questions
Must manufacturers rebuild all their existing CE processes?
No. Many basic principles remain relevant. Start with a structured gap assessment and focus on what changes for the actual product and date.
Does the Regulation also cover partly completed machinery?
Yes. It sets out a separate route, including technical documentation, assembly instructions and the EU declaration of incorporation.
Can modifying an existing machine create a new manufacturer role?
Yes. A substantial modification can make the person carrying it out responsible as a manufacturer for the affected product.
Can instructions for use be supplied digitally?
Yes, subject to the conditions in the Regulation. Access, usability, availability and paper-on-request obligations need to be considered.
Does the Machinery Regulation cover cybersecurity?
It includes safety requirements relevant to protection against certain corruptions of safety-related systems. Where this affects machinery safety, the risks and protective measures belong in the risk assessment and evidence record.
Sources and editorial date
Editorial review: 16 October 2026
Legal source edition: Regulation (EU) 2023/1230, consolidated 27 July 2026.
- EUR-Lex — Machinery Regulation (EU) 2023/1230, especially Articles 10–11, 17–19, 25 and Annexes III–IV
- European Commission — Machinery
- BAuA — Machinery Directive revision (German authority overview)
Note: General regulatory and technical guidance only. This page is not legal advice, a conformity assessment, certification or a product-specific compliance decision.
Page updated: