Machinery Directive vs Machinery Regulation: Key Differences

Directive vs Regulation: the side-by-side comparison

Most of your Directive knowledge still applies. The table shows where the two texts differ. Check the consolidated text on EUR-Lex before you rely on details.

For a broader overview of the new law, see our guide to the Machinery Regulation 2023/1230 changes.

Legal form, dates and the per-unit transition

A directive must be transposed into national law, which created small differences between countries. A regulation applies directly in all Member States (Article 54). Each Member State still decides the language of instructions.

The Regulation was published on 29 June 2023 and entered into force on 19 July 2023. It applies from 20 January 2027, and the Directive is repealed on the same day (Articles 51 and 54). Some copies of the Official Journal text still show 14 January 2027. A corrigendum (OJ L 169, 4.7.2023, p. 35) corrected the dates.

The transition works unit by unit, because placing on the market happens for each individual product. Two rules in Article 52 matter:

• Products placed on the market in conformity with the Directive before 20 January 2027 can still be made available afterwards, for example from a distributor's stock (Article 52(1)).
• EC type-examination certificates issued under the Directive remain valid until they expire (Article 52(2)). Ask your notified body how it handles them for units you place on the market under the Regulation.

The rules on notified bodies (Articles 26 to 42) apply from 20 January 2024. In NANDO, the Commission's database of notified bodies, search under Regulation (EU) 2023/1230: a notification under the Directive alone is not enough for new certificates.

Scope and definitions: what is new

The Directive used "machinery" in a broad sense. The Regulation separates three groups: machinery, related products and partly completed machinery (Article 2(1)). Related products are interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, and removable mechanical transmission devices.

Two definitions deserve attention:

• Safety component. It can be a "physical or digital component, including software" (Article 3(3)). Software ensuring safety functions is in the indicative list of Annex II, point 18. Safety software written for one machine and not sold separately remains part of that machine.
• Substantial modification. The Directive did not define it. Article 3(16) now sets four cumulative criteria, and Article 18 makes the person who carries out the modification the manufacturer. Digital changes count. Our guide on substantial modification of machinery explains the criteria.

From Annex IV to Annex I: conformity routes

Annex IV of the Directive becomes Annex I of the Regulation, in two parts (Articles 6 and 25):

• Part A always needs a notified body, even when harmonised standards are applied in full (Article 25(2)). It includes removable mechanical transmission devices and their guards, vehicle servicing lifts, portable cartridge-operated fixing and other impact machinery, and safety components or embedded systems with fully or partially self-evolving behaviour using machine learning that ensure safety functions.
• Part B allows internal production control (module A) only with harmonised standards or common specifications specific to the category, covering all relevant requirements, applied in full (Article 25(3)). Otherwise you need module B + C, H or G.
• Machinery not listed in Annex I uses module A only (Article 25(4)).

Vehicle servicing lifts show the practical effect. Under the Directive, full application of harmonised standards allowed self-assessment. Under the Regulation, they sit in Part A, so that route is closed. Many Part B entries look familiar, but read each one and its conditions again.

One limit is easy to miss. If section 1.1.9 or the cybersecurity parts of section 1.2.1 apply to a Part B machine and nothing under the Regulation gives presumption for them, module A is not available.

New essential requirements in Annex III

The essential health and safety requirements (EHSRs) move to Annex III. The section numbering is similar to the Directive, but the content has changed:

• Protection against corruption (1.1.9). Connecting a device, including a remote one, must not create a hazardous situation. Safety-critical software and data must be identified and protected, the machine must identify its safety software, and interventions in it must leave evidence. Recital 25 limits these measures to the protection of safety.
• Control systems (1.2.1). They must withstand "reasonably foreseeable malicious attempts from third parties leading to a hazardous situation". A tracing log of interventions and of safety software versions uploaded after placing on the market must be enabled for five years after the upload.
• Self-evolving behaviour. The risk assessment must cover hazards foreseeable as an intended evolution of the machine's behaviour (Annex III, Part B, point 1). Their control systems must not act beyond their defined task and movement space.
• Autonomous mobile machinery. Chapter 3 defines it, together with a supervisor and a supervisory function (section 3.1.1).
• Other changes. Section 1.2.6 now covers failure of the communication network, and section 1.3.7 addresses psychological stress from human-machine interaction.

As of October 2026, no harmonised standard covers the cybersecurity and AI-related requirements. You meet them with documented solutions and evidence. Regulation (EU) 2026/1744 has also amended the Machinery Regulation: delegated acts adding AI-related health and safety requirements to Annex III shall apply by 2 August 2028.

Instructions, declarations and the technical file

Instructions. Digital instructions are allowed if the user can find, print and save them, and if they stay online for the machine's expected lifetime and at least 10 years. A paper copy must be supplied free of charge within one month if the user asks at the time of purchase. Where use by non-professional users is intended or reasonably foreseeable, the essential safety information must also be on paper (Article 10(7)). Section 1.7.4.1 no longer uses the labels "original instructions" and "translation of the original instructions".

Declaration of conformity. The title becomes "EU declaration of conformity", with the content of Annex V, Part A. The Directive required the name and address of the person authorised to compile the technical file. Annex V, Part A does not list this element. The machine can be accompanied by the declaration, or the instructions can give an internet address or machine-readable code where it can be accessed (Article 10(8)).

Marking and contact details. Manufacturers must give a website, email address or other digital contact in addition to the postal address (Article 10(6)).

Partly completed machinery. The concept stays. It must meet the relevant essential requirements, carries no CE marking under the Regulation and comes with a declaration of incorporation (Annex V, Part B) and assembly instructions (Annex XI). See our guide to partly completed machinery.

Technical documentation. Annex IV sets the content. New elements include the source code or programming logic of safety-related software on reasoned request, a description of sensor-fed, remote or autonomous systems and their data, and tests showing safe assembly and putting into service (points (m) to (o)).

What does not change

• The iterative risk assessment and risk reduction method (Annex III, Part B, point 1). EN ISO 12100 remains the usual method; a revision is expected in late 2026, and its core logic stays.
• The type A, B and C system of machinery standards. The first list under the Regulation is expected to contain mostly standards already cited under the Directive, some possibly with restrictions. A Directive citation gives no presumption under the Regulation.
• Module A for machinery not listed in Annex I.
• Electrical hazards stay within the machinery law, so no separate Low Voltage Directive assessment.
• Keeping the technical documentation and declaration for at least 10 years.

What to do before 20 January 2027

1. List your models and when units will be placed on the EU market.
2. Check each product against Annex I, Part A and Part B, and against the new definitions, including software safety components.
3. If a notified body is needed, check NANDO for bodies notified under the Regulation and plan the timing.
4. Update the risk assessment for remote access, corruption of software and data, network failure and, where relevant, self-evolving behaviour. Define which future software updates are foreseen.
5. Map your standards to Annex III, mark the gaps and watch for the first implementing decision citing standards under the Regulation.
6. Restructure the technical file to Annex IV and update the declaration, nameplate and instructions.

Our Machinery Regulation course works through these steps with a full example, and CE Marking Fundamentals covers the wider CE route.

Key points

• The Directive covers units placed on the market up to 19 January 2027; the Regulation covers every unit from 20 January 2027.
• The Directive's Annex IV list becomes Annex I: Part A always needs a notified body, Part B only allows module A with category-specific standards applied in full.
• Protection against corruption, malicious attempts on control systems and self-evolving behaviour are new topics in Annex III.
• Digital instructions are allowed under conditions, and the declaration no longer names the person authorised to compile the technical file.
• The risk assessment method stays, but Directive standard citations do not carry over automatically.