The EU Machinery Regulation (EU) 2023/1230 applies on a mandatory basis from 20 January 2027. Until then, machinery newly placed on the EU market must comply with Directive 2006/42/EC. Start preparation by identifying the product, your role and the relevant market date. European Commission: machinery legislation.
This guide helps manufacturers, importers and engineering teams organise a transition review. It provides a decision framework and a working checklist; the product-specific conclusion depends on the applicable legislation and evidence.
When does Regulation (EU) 2023/1230 replace the Machinery Directive?
| Situation | Starting point for your review |
|---|---|
| Machinery first placed on the EU market before 20 January 2027 | Assess it against Directive 2006/42/EC. Preparing for the Regulation does not replace this obligation. |
| New placing on the market from 20 January 2027 | Plan for Regulation (EU) 2023/1230 and confirm the product’s scope and applicable route. |
| Products already lawfully placed on the market before that date | Article 52 protects their continued availability; the changeover is not a blanket ban on existing stock. |
| Existing equipment receives a physical or software change | Record what changed and examine the modification rules separately. An installation date alone does not resolve this question. |
Sources: Commission transition guidance and Regulation, Articles 3, 18 and 52–54.
Practical step: create a row for each product configuration and destination market. Add the planned transaction date, responsible economic operator and evidence supporting your classification. Resolve uncertain cases before production and delivery schedules are fixed. Keep those decisions with the product record so sales, engineering and purchasing use the same assumptions.
Will your machinery need a notified body?
The answer depends on its category and conformity-assessment route. Do not assume that every machine needs third-party certification, or that using a standard always permits self-assessment.
The table covers machinery and related products under Article 25. Partly completed machinery has separate manufacturer obligations under Article 11, including technical documentation, assembly instructions and an EU declaration of incorporation.
| Classification | Conformity-assessment starting point |
|---|---|
| Annex I, Part A | A route involving a notified body is required. |
| Annex I, Part B | Internal production control is available only when the relevant harmonised standards or common specifications are specific to the category and cover all relevant essential requirements. Otherwise a notified-body route is needed. |
| Outside Annex I | Internal production control is the route specified by Article 25(4). |
Check the precise category and conditions in Article 25. The official EUR-Lex summary explains these routes. Where a notified body is needed, verify its notification and scope through the NANDO link on the Commission machinery page before requesting a quotation.
Prepare an assessment brief covering machine function, intended users, variants, safety functions, category and proposed evidence. Ask the body to confirm what it will assess and what remains your responsibility. Build the schedule around an actual quotation and evidence gaps.
Image source: Bureau Veritas Cybersecurity.
What changes should engineering teams examine?
Connected machinery and software safety
The Regulation addresses cyber-safety and AI-related safety functions. Treat these as product-specific engineering questions. Start with a diagram showing remote connections, update paths, safety-related software and the people authorised to change it. Connect each credible failure or interference scenario to the affected safety function and the evidence needed to assess it. Commission overview.
Substantial modifications
Articles 3(16) and 18 set specific conditions for substantial modification and resulting manufacturer duties. A repair or software update is not automatically a new conformity-assessment project. Check the full definition against the change, the original design assumptions and its safety effects. Read the Regulation.
A useful change record describes the before-and-after configuration, why the change is needed, which hazards may be affected and who approves the conclusion. Include the limits of the review: a conclusion for one component should not silently become a conclusion for an entire production line.
Digital instructions
Digital instructions must support downloading and printing and remain available online for the expected lifetime and at least ten years after placing on the market. Article 10(7) also covers free paper instructions requested at purchase, supplied within one month, and essential paper safety information for non-professional users. Check Article 10(7).
Test the experience as a customer: find the correct model, download the relevant revision and read it when the machine or internet connection is unavailable. Assign an owner for hosting, archived versions, translations and paper requests.
Which machinery standards should you use?
Harmonised standards are voluntary. Legal requirements remain mandatory, and other technical solutions may be used to demonstrate compliance. A newer catalogue edition is not automatically the edition cited in the Official Journal. Commission explanation of harmonised standards.
Status checked 24 September 2026: the Commission says the first list supporting the Machinery Regulation is being prepared and is expected before the end of 2026. It anticipates carrying over most currently cited Machinery Directive standards, with clarifications where new or changed requirements are not fully covered. Check the live Commission machinery standards page and the relevant OJEU decisions before relying on a reference.
Build a standards register around your product’s hazards and functions: risk assessment, safety-related controls, electrical equipment and machine-specific requirements. For each candidate, record the exact EN reference and edition, scope, legal act, citation conditions and remaining gaps. Keep purchase and licensing records alongside the register. Our OJEU verification guide explains the checks.
A practical 2026 preparation checklist
Use this as a project worksheet. Add an owner, due date and evidence link to every row. These suggested records help organise your review; the table is not a complete list of legal requirements.
| Workstream | Question to resolve | Suggested record |
|---|---|---|
| Scope and timing | Which configurations and transactions are affected? | Product register with documented market-date assumptions. |
| Responsibilities | Who owns each decision and supplier input? | Responsibility matrix and unresolved questions. |
| Assessment route | What supports the chosen category and procedure? | Classification rationale and any scoped notified-body quotation. |
| Safety evidence | Which design or software changes need analysis? | Gap log linking each question to a drawing, test or review. |
| Standards | Are the editions and legal citations appropriate? | Standards register with sources and a recheck date. |
| Customer documents | Can users obtain the correct instructions? | Model-to-document map and tested access process. |
| Release decision | What remains unresolved before supply? | Sign-off record naming remaining actions and responsible people. |
Begin with one representative machine and run the worksheet from beginning to end. Use the gaps to estimate the work for the rest of the portfolio. Revisit legal and standards references before release, especially while the new harmonised-standards list is being prepared.