High-risk machinery under Annex I: Part A, Part B and the right procedure

In brief

Annex I has two parts: Part A with 6 categories, Part B with 19 categories (Art. 6(1)).
Part A: always with a notified body – type-examination followed by internal production control (B+C), full quality assurance (H) or unit verification (G).
Part B: internal production control (A) only if harmonised standards or common specifications cover all relevant requirements; otherwise B+C, H or G.
Not in Annex I: internal production control (module A) (Art. 25(4)).

Art. 6Annex IArt. 25

Annex I Part A

Categories to which a procedure under Art. 25(2) applies:

Removable mechanical transmission devices, including their guards
Guards for removable mechanical transmission devices
Vehicle servicing lifts
Portable cartridge-operated fixing and other impact machinery
Safety components with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions
Machinery that has embedded systems with fully or partially self-evolving behaviour using machine learning approaches ensuring safety functions that have not been placed on the market separately – only in respect of those systems

Annex I Part B

Categories to which one of the procedures under Art. 25(3) applies:

Circular saws (single- or multi-blade) for wood or meat and materials with similar characteristics (four types, points 1.1 to 1.4)
Hand-fed surface planing machinery for woodworking
Thicknessers for one-side dressing of wood with built-in mechanical feed and manual loading or unloading
Band-saws with manual loading or unloading for wood or meat (two types, points 4.1 and 4.2)
Combined machinery of the types in points 1 to 4 and 7 for woodworking
Hand-fed tenoning machinery with several tool holders for woodworking
Hand-fed vertical spindle moulding machinery for woodworking
Portable chainsaws for woodworking
Presses, including press-brakes, for the cold working of metals with manual loading or unloading, whose movable working parts may have a travel exceeding 6 mm and a speed exceeding 30 mm/s
Injection or compression plastics-moulding machinery with manual loading or unloading
Injection or compression rubber-moulding machinery with manual loading or unloading
Machinery for underground working: locomotives and brake-vans; hydraulic-powered roof supports
Manually loaded trucks for the collection of household refuse incorporating a compression mechanism
Devices for the lifting of persons or of persons and goods involving a hazard of falling from a vertical height of more than 3 m
Protective devices designed to detect the presence of persons
Power-driven, interlocking movable guards designed for the machinery in points 9, 10 and 11
Logic units to ensure safety functions
Roll-over protective structures (ROPS)
Falling-object protective structures (FOPS)

Which procedure applies

Your machine	Permitted procedures	Notified body
not in Annex I	internal production control (module A, Annex VI)	no
Annex I Part B, standards or common specifications cover all relevant requirements	A, B+C, H or G	no for module A, otherwise yes
Annex I Part B, standards do not cover everything	B+C (Annexes VII and VIII), H (Annex IX) or G (Annex X)	yes
Annex I Part A	B+C, H or G	always

The crux for Part B: harmonised standards

For Part B, module A is only permitted if the machinery was designed and constructed in accordance with harmonised standards or common specifications covering all relevant essential requirements for that category (Art. 25(3)). Presumption of conformity is tied to standards whose references are published in the Official Journal (Art. 20(1)). Before choosing module A, check which standards are published for your category under the Regulation and whether they also cover the new requirements – for example on software and cybersecurity. Without full coverage, the route goes through a notified body.

How to check

Classify: machinery, related product or partly completed machinery (Arts 2, 3)?
Compare: does the product fall under a category in Annex I Part A or B – including with embedded machine-learning safety systems?
Clarify the standards: for Part B, do standards with published references or common specifications cover all relevant requirements?
Choose the procedure and ask early: notified bodies are listed in the Commission’s NANDO database; their identification number will accompany the CE marking.
Document: classification, reasoning and chosen procedure go into the technical documentation; the procedure also into the declaration of conformity (Annex V Part A).

The list can change

The Commission may amend Annex I by delegated acts – adding, removing or moving categories between parts (Art. 6(2)). A category goes into Part A where there is a serious inherent risk and further conditions, for example missing harmonised standards or repeated serious accidents (Art. 6(7)). Check the list before every new declaration.

Frequently asked questions

Does Part B always need a notified body?

No. If harmonised standards or common specifications cover all relevant requirements and you have applied them, module A is permitted (Art. 25(3)).

Does every machine with AI fall under Part A?

No. Part A covers safety components and embedded systems with self-evolving behaviour through machine learning that ensure safety functions. Software that does not learn and only executes programmed functions is not covered, according to recital 55.

What about my EC type-examination certificate under the Directive?

It remains valid until it expires (Art. 52(2)) – for machinery placed on the market under the Directive. For placing on the market under the Regulation, the procedure of Art. 25 applies.

Who decides whether my machine falls under Annex I?

First the manufacturer, who justifies and documents the classification. In case of doubt, consulting a notified body helps; binding interpretation lies with authorities and courts.

High-risk machinery under Annex I: is my machine on the list?