European Union - Machinery and industrial equipment
CE marking and compliance requirements for machinery and industrial equipment
Machines and industrial equipment intended primarily for professional use. EU machinery legislation anchors the category; consumer-facing general product safety rules are omitted because these are not consumer products.
For example: benchtop CNC router, conveyor module, industrial mixer, laser engraver.
GPSR/UK GPSR and the US CPSA are omitted because they cover consumer products — but if consumers are reasonably likely to use the machine (e.g. hobby CNC), those regimes re-attach: verify for your product and add the general-consumer rules. Machinery Directive 2006/42/EC applies until 20 January 2027, then Machinery Regulation (EU) 2023/1230 (Annex I lists high-risk machinery needing notified-body assessment). UK: Supply of Machinery (Safety) Regulations 2008 — not a separate id here, verify. Large-scale stationary industrial tools and fixed installations are excluded from RoHS/WEEE — verify whether your equipment qualifies. AI-based safety components in machinery are high-risk AI systems under the EU AI Act — verify (eu-ai-act not auto-applied here). Laser engravers additionally face laser product safety rules (EN 60825; US FDA 21 CFR 1040) — verify. UK PSTI covers consumer connectable products only, so it is not applied. US NRTL listing is mandatory for electrical equipment used in workplaces under OSHA.
Base requirements6 instruments
Requires electrical and electronic equipment not to generate excessive electromagnetic disturbance and to be adequately immune to it. Compliance is normally self-assessed and leads to CE marking.
Key obligations
- 01Ensure apparatus is designed and manufactured in accordance with the essential requirements of Annex I (limited electromagnetic emissions; adequate immunity for intended use) — Article 7.source
- 02Draw up the technical documentation and carry out the relevant conformity assessment procedure (Article 7(2)).source
- 03Draw up an EU Declaration of Conformity and affix the CE marking; keep the technical documentation and DoC for 10 years (Article 7(2)-(3)).source
- 04Provide information on any specific precautions needed when the apparatus is assembled, installed, maintained or used, so that it preserves EMC conformity.sourceUnverified — check source
Replaces the Machinery Directive 2006/42/EC from 20 January 2027 with directly applicable EU-wide rules for machinery safety, adding provisions for digital technologies (AI, connectivity) and allowing digital instructions. Manufacturer obligations do not apply until that date; until then the Machinery Directive governs.
Key obligations
- 01Design and construct machinery in accordance with the essential health and safety requirements (EHSRs) set out in Annex III (Article 10).source
- 02Draw up the technical documentation, carry out the relevant conformity assessment procedure, issue the EU Declaration of Conformity and affix the CE marking (Article 10).source
- 03Provide instructions for use — digital instructions are permitted if the machinery is marked with how to access them, they can be printed and downloaded, and they remain available online for the expected lifetime and at least 10 years; safety information for non-professional users must still be provided in paper form (Article 10(7)).source
- 04Machinery categories listed in Annex I Part A must undergo mandatory third-party conformity assessment; other listed categories (Part B) may self-assess when built to harmonised standards covering all relevant EHSRs.source
The EU's enforcement framework for product rules. Its Article 4 is the practical blocker for online sellers: since 16 July 2021, most CE-marked goods can only be placed on the EU market if an economic operator established in the EU is responsible for compliance tasks — and that operator's contact details must accompany the product.
Key obligations
- 01A product covered by the Article 4 list may only be placed on the EU market if there is an economic operator established in the Union responsible for the Article 4 tasks (applies since 16 July 2021).source
- 02That operator can be: the manufacturer established in the EU; an importer (where the manufacturer is not established in the EU); an authorised representative with a written mandate; or an EU-established fulfilment service provider handling the products (Article 4(2)).source
- 03The operator's tasks (Article 4(3)): verify that the EU Declaration of Conformity and technical documentation exist and keep the DoC available; provide information and documentation to authorities on request; inform authorities when a product presents a risk; cooperate on corrective action.source
- 04The name, registered trade name or trade mark and contact details (including postal address) of the Article 4 operator must be indicated on the product or on its packaging, the parcel or an accompanying document (Article 4(4)).source
The EU's chemicals regulation. For physical-product (article) sellers the practical duties are: communicating Candidate List substances of very high concern (SVHCs) above 0.1% down the supply chain and to consumers, notifying ECHA in some cases, and respecting the Annex XVII restrictions. Full chemical registration applies to substance manufacturers/importers, not typical article sellers.
Key obligations
- 01Article 33(1): if an article contains a Candidate List SVHC above 0.1% weight by weight, provide recipients (businesses in the supply chain) with sufficient information for safe use — at minimum the name of that substance. This applies per article within a complex product.source
- 02Article 33(2): on request from a consumer, provide the same safe-use information (at minimum the substance name) within 45 days, free of charge.source
- 03Article 7(2): EU producers/importers of articles must notify ECHA when a Candidate List substance is present above 0.1% w/w AND its total quantity in those articles exceeds 1 tonne per producer/importer per year — no later than 6 months after the substance is added to the Candidate List. Notification is not required where exposure of humans and the environment can be excluded.source
- 04Notify articles containing Candidate List SVHCs above 0.1% w/w to ECHA's SCIP database (a duty under the Waste Framework Directive, submitted via ECHA).sourceUnverified — check source
Restricts ten hazardous substances — including lead, mercury, cadmium and four phthalates — in electrical and electronic equipment. Compliance is self-assessed, documented through material declarations, and forms part of the CE marking.
Key obligations
- 01Ensure homogeneous materials do not exceed the Annex II maximum concentrations: 0.1% by weight for lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP and DIBP; 0.01% for cadmium.source
- 02The four phthalates (DEHP, BBP, DBP, DIBP) were added by Delegated Directive (EU) 2015/863 and apply to most EEE from 22 July 2019 (medical devices and monitoring/control instruments from 22 July 2021).source
- 03Carry out the internal production control procedure in line with Module A of Decision 768/2008/EC, draw up technical documentation, and keep it (with the EU Declaration of Conformity) for 10 years (Article 7).source
- 04Draw up an EU Declaration of Conformity and affix the CE marking to the finished product (Article 7).source
Extended producer responsibility for electronics: producers must register in each EU country where they sell, finance the collection and recycling of e-waste, and mark products with the crossed-out wheeled bin symbol. It is a waste-law obligation, separate from CE marking.
Key obligations
- 01Register as a producer in the national WEEE register of each Member State where you place EEE on the market before selling there (Article 16).source
- 02Finance at least the collection, treatment, recovery and environmentally sound disposal of WEEE from private households (Article 12; Article 13 covers non-household WEEE) — in practice usually via a producer compliance scheme.source
- 03Distance sellers: appoint an authorised representative in each Member State where you sell but are not established, to fulfil the producer obligations there (Article 17).source
- 04Mark EEE with the crossed-out wheeled bin symbol shown in Annex IX (Article 14(4)), plus a mark identifying that it was placed on the market after 13 August 2005 (Article 15(2)).source
If your product also...
Extra regulations triggered by specific features
Has radio / wireless (Wi-Fi, Bluetooth, cellular, GPS, RFID/NFC)
Contains a battery
Connects to the internet / runs updatable software
Documents you will need
Deduplicated across the regulations above
- EU Declaration of ConformityKept for 10 years after the apparatus is placed on the market.source
- Technical documentationIncludes the EMC assessment and test reports; kept for 10 years.source
- Instructions and EMC use informationInformation needed to install/use the apparatus in accordance with its intended purpose without breaching EMC requirements.source
- Instructions for useDigital format allowed with access marking, printability and 10-year availability; paper safety information mandatory for non-professional users.source
- Written mandate (when using an authorised representative)The authorised representative must hold a written mandate covering the Article 4 tasks.source
- EU Declaration of Conformity + technical documentation availabilityThe EU operator must be able to verify these exist and produce them for authorities on request.source
- Supplier declarations / full material disclosuresEvidence that Candidate List SVHCs are below 0.1% w/w per article, or the basis of your Article 33 communications.source
- Article 33 safe-use communicationsRecords of the information passed to recipients and provided to consumers within the 45-day deadline.source
- Technical documentation per EN IEC 63000Material declarations, analytical test reports and supplier certificates organised per the harmonised documentation standard.source
- National producer register entries and registration numbersMany Member States require the WEEE registration number on invoices/webshop; requirements vary nationally.source
- User informationInstructions/packaging must inform users about separate collection and the crossed-out bin symbol.source
- Treatment information for recyclersFree of charge, identifying components, materials and the location of dangerous substances (Article 15).source
Frequently asked
Does my Wi-Fi/Bluetooth product fall under the EMC Directive?+
No — radio equipment is excluded from the EMC Directive and is covered by the Radio Equipment Directive 2014/53/EU instead, which incorporates the same EMC essential requirements. Your Declaration of Conformity should cite the RED, not the EMC Directive, for radio products.
Can I still CE-mark machinery under the old Machinery Directive?+
Yes, until 20 January 2027 — the Machinery Directive 2006/42/EC remains the applicable law for machinery placed on the market before that date. From 20 January 2027 every machine placed on the market must comply with Regulation (EU) 2023/1230 instead; there is no overlap period.
I sell CE-marked products online from outside the EU — do I need someone in the EU?+
Yes, for products on the Article 4 list (most CE-marked consumer goods). Since 16 July 2021 they can only be placed on the EU market if an EU-established economic operator — importer, authorised representative or fulfilment service provider — is responsible for the compliance tasks, and their details must accompany the product.
I sell finished products, not chemicals — does REACH really apply to me?+
Yes, in a limited way. You don't register chemicals, but you must know whether any Candidate List substance of very high concern exceeds 0.1% by weight in any article you supply, tell business customers proactively, and answer consumer requests within 45 days.
Which substances does RoHS restrict?+
Ten: lead, mercury, cadmium, hexavalent chromium, the flame retardants PBB and PBDE, and the phthalates DEHP, BBP, DBP and DIBP. The limit is 0.1% by weight in each homogeneous material, except cadmium at 0.01%.
Do I need to register for WEEE in every EU country I sell to?+
Effectively yes. Producer registration is national, so selling into a Member State (including online direct-to-consumer) triggers registration there. If you have no establishment in that country, you must appoint an authorised representative to register and comply on your behalf.
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