EU Machinery Regulation 2023/1230 Checklist

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9 critical items still open - these are the highest-risk gaps.

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Scope and product mapping

List every product that is machinery, partly completed machinery or a safety component under your current Machinery Directive file.CRITICALCheck each product against the new definitions and the list of high risk categories in Annex I.CRITICALIdentify products that include software with safety functions or self-evolving behaviour.Mark which products you place on the EU market and which only ship elsewhere.Record the intended transition date for each product family.Identify related products, such as interchangeable equipment, that now need separate assessment.

Conformity assessment route

Determine for each product whether internal production control is allowed or a notified body is needed.CRITICALCheck whether harmonised standards cover the essential health and safety requirements.Contact the notified body early for high risk products and confirm capacity.CRITICALPlan for assessment of cybersecurity aspects that affect safety.Record which standards and versions you apply for each product.Define a procedure for substantial modifications of existing machines.

Technical documentation

Review each technical file for the content the new regulation requires.CRITICALInclude risk assessment records with traceable hazard and mitigation links.Keep drawings, circuit diagrams and calculations under revision control.Store test reports and supplier component declarations with the file.Define the retention period for technical documentation and make it retrievable.CRITICALPrepare the instructions in the digital or paper format you intend to offer, in the required languages.

Declaration, marking and traceability

Update the EU declaration of conformity template for the new regulation.CRITICALCheck CE marking rules, including placement and notified body number where applicable.Assign type, batch or serial identification and make it consistent across documents.Make sure name and contact details of manufacturer, importer and authorised representative are on the product.Prepare a process for providing the declaration or its internet address with the product.Define how you will handle product recalls and customer notification.

ERP and PLM data readiness

Link each sellable item in the ERP to its technical file and declaration of conformity.CRITICALStore the applicable standards and regulation version as attributes on the item or product family.Use revision control so that the file valid at the time of manufacture can be retrieved by serial number.CRITICALHold supplier declarations for safety components against the supplier item.Block shipment of products whose declaration is expired or missing.Run a report listing products without a linked technical file.

Treat unchecked critical items as open risks for each product family. The regulation applies from 20 January 2027 and replaces Directive 2006/42/EC; confirm transition arrangements, applicable harmonised standards and your assessment route with your notified body, legal counsel or national authority. This checklist is planning support, not legal advice.

ERP gap scan for CE documentation

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How to use the checklist

Run the checklist per product family, not once for the whole company. Tick what is already true, leave gaps open and assign an owner to each. Critical items are those that determine whether you can legally ship under the new regime, such as the assessment route and the technical file. Export the result to PDF and use it as input to your transition plan with quality, engineering, legal and IT.

What changes for machinery manufacturers

Compared with the directive, the regulation is directly applicable in all member states, updates the list of high risk machinery, adds requirements for software and digital safety functions, addresses substantial modification and allows digital instructions under conditions. It also strengthens obligations for importers and distributors. The scope of notified body involvement depends on the product and on the availability of harmonised standards, so check this early rather than at the end.

High risk categories are listed in an annex and may need third-party assessment.
Software and AI related safety functions get explicit attention.
Technical documentation must be kept available for a defined period.
Instructions may be provided digitally under conditions.

The ERP and PLM angle

Compliance is evidenced by documents, and documents must be found by product and by serial number years later. An ERP that links item, revision, serial, technical file and declaration gives you that. Without it, teams search shared drives during audits. At minimum, hold the applicable standard and regulation version on the item, link the declaration, and prevent shipment of an item whose declaration is not valid.

Common mistakes

Manufacturers commonly assume the existing CE file is enough without a gap analysis, leave the notified body discussion to the last year, and forget that software updates can change the safety assessment. Another is treating the declaration as a PDF template only, instead of tying it to revision controlled product data.

Frequently Asked Questions

When does Regulation (EU) 2023/1230 apply?

It applies from 20 January 2027, replacing Directive 2006/42/EC. Confirm any transitional rules for products already on the market with your notified body or national authority, because the details depend on the product and its status.

Do I always need a notified body now?

No. Many products can still use internal production control, but certain high risk categories require third-party involvement, particularly when harmonised standards do not fully cover them. Check the annex and your standards position product by product.

How long must technical documentation be kept?

The regulation sets a defined retention period measured from placing on the market. Check the exact period in the text for your product type, and make sure your ERP or document system can retrieve the file by serial number for that long.

Does the checklist cover importers and distributors?

It focuses on manufacturers. Importers and distributors have their own obligations, such as verifying marking and documentation. If you also import or distribute, extend the checklist with those duties and review them with counsel.

Netray can help find the ERP and document gaps, such as items without linked technical files, using a read-only scan on your own infrastructure.

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