Machinery Directive vs Machinery Regulation: all differences in one table

In brief

From 20 January 2027 Directive 2006/42/EC is repealed; references to it are construed as references to the Regulation (Art. 51(2)). There is no period in which either can be applied at will.
The principle stays the same: risk assessment, essential requirements, technical documentation, conformity assessment, declaration, CE marking.
The main changes: two groups of high-risk machinery, requirements on software, cybersecurity and self-evolving behaviour, autonomous mobile machinery, digital instructions and obligations for importers and distributors.
The annexes are reorganised: the essential requirements are now in Annex III, the list of high-risk machinery in Annex I.

The differences at a glance

Topic	Directive 2006/42/EC	Regulation (EU) 2023/1230	Reference
Legal form	directive, transposed into national law	regulation, directly applicable in every Member State	Art. 54
Scope	machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, transmission devices, partly completed machinery	machinery and “related products” (interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices) and partly completed machinery	Art. 2(1)
Software	not expressly covered in the definition of machinery	an assembly missing only the upload of the intended software is machinery; safety components can be digital, including software with a safety function placed on the market separately	Art. 3(1)(f), 3(3)
High-risk machinery	one list in Annex IV	two parts: Annex I Part A (6 categories, always with a notified body) and Part B (19 categories)	Art. 6, Annex I
Conformity assessment	internal checks, EC type-examination, full quality assurance	modules A, B+C and H, new unit verification (module G); for Annex I Part A no internal production control	Art. 25
Essential requirements	Annex I	Annex III, extended with protection against corruption, software in control systems, self-evolving behaviour, human-machine interaction and autonomous mobile machinery	Annex III 1.1.6, 1.1.9, 1.2.1, 1.3.7, 3.2.4
Technical documentation	Annex VII	Annex IV (Part A for machinery, Part B for partly completed machinery); source code or programming logic on reasoned request	Art. 10(3), Annex IV
Declaration of conformity	Annex II, naming the person authorised to compile the technical file	Annex V Part A; a single declaration for all acts; access also via internet address or machine-readable code	Art. 21, Art. 10(8)
Instructions	paper	digital allowed, online for at least ten years; paper on request at purchase; safety information always on paper for non-professional users	Art. 10(7)
Marking and contact	name and address of the manufacturer	also website, e-mail or other digital contact; a single contact point; year of construction = year the manufacturing process was completed	Art. 10(5), (6)
Economic operators	manufacturer and authorised representative	also obligations for importers and distributors; traceability for ten years	Arts 13–17, 19
Substantial modification	not defined in the Directive	defined; whoever carries it out is considered the manufacturer	Art. 3(16), Art. 18
Post-market monitoring	—	sample testing, complaints, register of recalls, where appropriate in view of the risks	Art. 10(4)

Where the old annexes are now

Content	Directive	Regulation
Essential requirements	Annex I	Annex III
EC/EU declarations of conformity and incorporation	Annex II	Annex V
CE marking	Annex III	Arts 23, 24
High-risk machinery	Annex IV	Annex I
Safety components (indicative list)	Annex V	Annex II
Assembly instructions	Annex VI	Annex XI
Technical documentation	Annex VII	Annex IV
Internal checks	Annex VIII	Annex VI (module A)
Type-examination	Annex IX	Annex VII (module B) with Annex VIII (module C)
Full quality assurance	Annex X	Annex IX (module H)
Unit verification	—	Annex X (module G)

The full correspondence of articles is set out in the correlation table in Annex XII of the Regulation.

What stays the same

The process changes little. The manufacturer assesses the risks, identifies the applicable requirements, designs accordingly, compiles the technical documentation, chooses the procedure, draws up the declaration and affixes the CE marking. The order of protective measures – first by design, then technical, finally information – is the same (Annex III 1.1.2). A clean file under the Directive needs to be completed, not rewritten.

What happens to machinery under the Directive

Products placed on the market in accordance with the Directive before 20 January 2027 may continue to be made available. EC type-examination certificates issued under the Directive remain valid until they expire (Art. 52). What counts, for each individual unit, is the date of placing on the market.

Frequently asked questions

Can I work under the Regulation right away?

Until 19 January 2027 placing on the market is governed by the Directive, from 20 January 2027 by the Regulation. If you design today and deliver in 2027, build the Regulation’s requirements into the design and the file now.

Does my machine now need a notified body?

Only if it is listed in Annex I. For Part A always; for Part B only if harmonised standards or common specifications do not cover all relevant requirements. All other machinery stays with internal production control (Art. 25).

Does the Regulation apply to machinery I only use myself?

Yes. Whoever manufactures machinery and puts it into service for their own use is a manufacturer (Art. 3(18)(b)).

Do I need new harmonised standards?

Presumption of conformity applies to standards whose references are published in the Official Journal (Art. 20(1)). Check before the declaration which standards are published for the Regulation – the list under the Directive does not carry over automatically.

Machinery Directive vs Machinery Regulation: what changes