EU Machinery Regulation Annex I high-risk categories

Article 6 divides Annex I into Part A and Part B. Part A categories must use one of the Article 25(2) procedures. Part B categories use Article 25(3), where internal production control is available only when the product is designed and constructed in accordance with harmonised standards or common specifications specific to that category and covering all relevant essential health and safety requirements.

The Regulation also explains how categories can be added, removed, or moved between parts. The Commission assesses the seriousness of inherent potential risk using probability of harm and severity of harm, with criteria such as hazard nature, persons affected, exposure, avoidability, safety-component failure consequences, accident data, close calls, market surveillance findings, and uncertainty in risk assessment methods for new technologies.

The current consolidated Regulation also contains Articles 25a to 25e for an activated internal market emergency. Those provisions apply only when the internal market emergency mode has been activated under Regulation (EU) 2024/2747, the Commission has adopted an implementing act for machinery or related products, and the product has been designated as crisis-relevant. They do not change whether a product belongs in Annex I and are not a standing alternative to the normal Article 25 route.

Annex I Part A contains a short list: 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; and machinery with embedded systems with such self-evolving behaviour ensuring safety functions, in respect only of those systems.

For these Part A categories, Article 25(2) does not offer Module A internal production control. The manufacturer, or the person responsible for a substantial modification under Article 18, must use EU type-examination followed by conformity to type, full quality assurance, or unit verification.

Annex I Part B carries the longer list. It includes specified woodworking and meat-processing saws, hand-fed planing and tenoning machinery, thicknessers, bandsaws, combined woodworking machinery, portable chainsaws, certain metalworking presses, injection or compression plastics and rubber moulding machinery with manual loading or unloading, specified underground-working machinery, manually loaded household refuse trucks with a compression mechanism, lifting devices for persons or persons and goods involving a vertical fall hazard of more than 3 m, protective devices detecting persons, certain power-operated interlocking movable guards, logic units for safety functions, roll-over protective structures (ROPS), and falling-object protective structures (FOPS).

Part B does not automatically require a notified body in every case. Article 25(3) permits Module A internal production control only where harmonised standards or common specifications specific to the category cover all relevant essential health and safety requirements and have been applied for design and construction. If that full coverage and application cannot be shown, the route changes to Module B plus Module C, Module H, or Module G.

A usable Annex I record should let a reviewer reproduce the classification without knowing the project history. Start with the product boundary, model or configuration, intended use, foreseeable misuse, market role, and whether the item is machinery, a related product, a safety component, or partly completed machinery.

Then attach the Annex I item analysis, the Article 25 route, and the evidence behind that route. For a Part B Module A route, the key evidence is the standards or common specifications coverage. For notified-body routes, keep the application, technical documentation, certificates, reports, quality-system decisions, and any changes or certificate reviews that affect the approval.

The main error is using a broad label such as high-risk machinery without tying it to an Annex I item and an Article 25 route. The Regulation's list is category-specific. A category decision should be based on the listed product type and its characteristics, not on a general view that the machine is dangerous.

Another recurring problem is confusing the Regulation's Annex I with the Machinery Directive's Annex IV. The legacy guide is still useful for understanding Directive classifications, but Regulation (EU) 2023/1230 moved the listed high-risk categories into Annex I and changed the legal route references.