Business

20 January 2027: What Changes When the EU Machinery Regulation Replaces Directive 2006/42/EC

The Kopik team7 min read

On 20 January 2027, Regulation (EU) 2023/1230 becomes applicable and Directive 2006/42/EC is repealed. Products placed on the EU market in conformity with the Directive before that date can continue to be made available. Anything placed on the EU market or put into service in the EU from that date must comply with the Regulation. Several provisions already apply, and an AI amendment adopted in July 2026 adds a further deadline of 2 August 2028.

Who this concerns, and what it does not cover

This guide is for UK machine builders, robot integrators and component suppliers whose products go to customers in the EU. It describes EU law only. The UK operates its own machinery regime, which the Kopik base does not include, so nothing below says anything about placing machinery on the UK market; check the official UK guidance for that. The European Commission's machinery page itself directs readers to separate sectoral guidance notices on Brexit.

The rule for machines already on the market

Article 52(1) of the Regulation is the grandfathering clause: Member States ‘shall not impede the making available on the market of products which were placed on the market in conformity with Directive 2006/42/EC before 20 January 2027’. The European Commission's machinery page puts the other side plainly: all machinery placed on the EU market before 20 January 2027 must comply with the Directive. Manufacturers may, if applicable, state on the EU declaration of conformity that such machinery also conforms with the Regulation.

What decides which text applies is the moment each product is placed on the market, defined as its first making available on the Union market (Article 3(12)), or put into service, its first use in the Union (Article 3(13)). Three practical cases follow from these definitions:

  • A palletiser shipped and delivered to a German customer in December 2026: placed on the market under the Directive; it can continue to circulate afterwards.
  • An identical palletiser from the same batch delivered in February 2027: a separate product placed on the market after the date, so it must comply with the Regulation.
  • A robot cell built in-house by an EU plant and first used in March 2027: put into service after the date, so the Regulation applies, with the plant as manufacturer under Article 3(18)(b).

Certificates do not lapse on the date

EC type-examination certificates and approval decisions issued under Article 12 of the Directive remain valid until they expire (Article 52(2)). Plan renewals under the Regulation's procedures accordingly.

Dates that already apply or are coming

Staggered application of Regulation (EU) 2023/1230 (consolidated text of 29 May 2026) and Regulation (EU) 2026/1744

DateProvision
19 July 2023Article 6(7), Articles 48 and 52; Union market surveillance (Chapter VI) applies to Directive products
20 January 2024Articles 26 to 42 on notified bodies
20 July 2024Article 6(2) to (6), (8) and (11), Articles 47 and 53(3)
24 July 2026Regulation (EU) 2026/1744 (Digital Omnibus on AI) published; in force on the third day after publication
20 October 2026National penalty rules (Article 50(1)) apply and are notified to the Commission
20 January 2027Regulation applies; Directive repealed
20 July 2028First Commission evaluation report (then every four years)
By 2 August 2028Delegated acts adding AI requirements to Annex III must apply

References to the repealed Directive in other legislation are to be read as references to the Regulation, using the correlation table in Annex XII (Article 51(2)). Penalties are set nationally and must be effective, proportionate and dissuasive, possibly including criminal penalties for serious infringements (Article 50(1)); the base does not include national penalty levels.

Five changes to plan for in your technical files

  1. Higher-risk categories. Annex I, Part A now includes safety components and embedded systems with self-evolving machine-learning behaviour ensuring safety functions; they require a notified-body procedure (Article 25(2)).
  2. Software and cyber-safety. Annex III, sections 1.1.9 and 1.2.1 require protection against corruption, identification of safety-relevant software, evidence of interventions, and a five-year tracing log of safety software versions uploaded after placing on the market.
  3. Digital instructions and declarations. Instructions may be digital if access is marked on the machine, they are printable and savable, and they stay online for the expected lifetime and at least 10 years; a free paper copy within one month if requested at purchase (Article 10(7)). The declaration can be provided via an internet address or machine-readable code (Article 10(8)).
  4. Fuller technical documentation. Annex IV, Part A adds, for sensor-fed, remotely driven or autonomous machinery, a description of capabilities, limitations, data and validation processes, and source code of safety software on reasoned request.
  5. Substantial modification is now defined (Article 3(16)) and triggers manufacturer obligations for whoever carries it out (Article 18).

The AI amendment of July 2026

Regulation (EU) 2026/1744 moved the Machinery Regulation from Section A to Section B of Annex I to the AI Act (Regulation (EU) 2024/1689). Its recital describes this as a ‘sectoral approach’: AI-specific health and safety requirements for high-risk AI systems used as safety components in machinery are to be written into Annex III of the Machinery Regulation by delegated acts that apply by 2 August 2028. Meanwhile, high-risk AI systems that follow harmonised standards or common specifications adopted under Articles 40 and 41 of the AI Act are presumed to conform with the relevant Annex III requirements (new Article 20(10)).

A transition plan for UK suppliers to the EU

  1. Map your delivery schedule against 20 January 2027: which units will be placed on the EU market or put into service before, and which after.
  2. Screen every product against Annex I, Parts A and B, paying particular attention to any safety function relying on machine learning.
  3. Rebuild the technical file to Annex IV, Part A, including the software, cyber-safety and sensor-related points, and copies of the declarations of incorporated products.
  4. Redraft declarations of conformity to the Annex V, Part A model, and decide whether to provide them by internet address or machine-readable code.
  5. Organise digital instructions so they remain online for the expected lifetime of the machine and at least 10 years, with a process for free paper copies on request.
  6. Brief your EU importer and distributors: under Articles 13 and 15 they must check the CE marking, documents and instructions before the product goes on the market, and they will apply the Regulation's requirements to post-transition deliveries.
  7. Track the AI delegated acts due to apply by 2 August 2028 if your products include AI-based safety functions.

What is still missing

  • An official guide. The Commission's application guide, edition 2.3 of April 2024, covers Directive 2006/42/EC. No equivalent guide to Regulation 2023/1230 has been published.
  • The AI delegated acts under the amended Article 8, due to apply by 2 August 2028.
  • Binding interpretation: the Commission notes that its services only provide generic guidance and that only the Court of Justice of the EU can give a binding interpretation; for product-specific questions it recommends contacting the relevant national market surveillance authority.

What does exist: notified bodies' ‘Recommendation for Use’ sheets concerning the Regulation (horizontal ones prefixed 00), listed on the European Commission's machinery page, and the NANDO database of bodies notified under both texts. The Commission also warns that ‘voluntary certificates’ issued outside the notified-body system are not a recognised means of proving compliance.

If you need a date or a clause confirmed quickly, ask the robot and cobot machinery safety base, for example: ‘Has the European Commission already published an official guide to applying Regulation 2023/1230?’

Every date, sourced

The base indexes the consolidated Regulation 2023/1230, the 2026 Digital Omnibus on AI, the Commission's machinery page and EU-OSHA's summary, with cited answers.

Frequently asked questions

When is Directive 2006/42/EC repealed?

With effect from 20 January 2027 (Article 51(2) of Regulation 2023/1230), the date from which the Regulation applies.

Can stock built to the Directive be delivered after 20 January 2027?

Only products already placed on the EU market in conformity with the Directive before that date benefit from Article 52(1). Each product placed on the market from 20 January 2027 must meet the Regulation.

Does the new Regulation need transposing into national law?

No. EU-OSHA notes that, as a regulation, it is directly applicable in Member States, unlike the Directive.

Does the base explain the UK's machinery rules after 2027?

No. The base covers EU law and US OSHA and NIOSH guidance only; consult the official UK guidance for the UK regime.

What is the deadline for AI requirements in the Machinery Regulation?

Regulation 2026/1744 requires the Commission's delegated acts adding AI requirements to Annex III to apply by 2 August 2028.

Do existing EC type-examination certificates become invalid in 2027?

No. Certificates and approval decisions issued under Article 12 of Directive 2006/42/EC remain valid until they expire (Article 52(2) of Regulation 2023/1230).

Get the Kopik newsletter

New knowledge bases, RAG guides and product news. One email every week or two, unsubscribe in one click.

By subscribing you agree to receive our newsletter. We never share your address.