EU Machinery Regulation Scope and Machine Categories

Article 2 brings machinery into scope and also lists related products: interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, and removable mechanical transmission devices. It also applies to partly completed machinery, so a product can be regulated even before it can perform a complete application on its own.

The first scope record should capture the product model, software or firmware version where relevant, intended application, whether at least one linked part moves, the drive system, and the EU event being assessed: placing on the market, putting into service, making available, incorporation into final machinery, or a post-market change.

Safety components deserve a separate check because the regulation covers physical and digital components, including software, when they are designed or intended to fulfil a safety function, are independently placed on the market, and their failure or malfunction endangers persons. A normal functional component does not become a safety component just because it is important to the product; the safety-function evidence has to be explicit.

Annex II is only an indicative list of safety components and can be amended as technical progress and knowledge change. Treat the list as a starting point, then verify the component's intended safety function, failure consequence, independent market placement, and relationship to the machinery or related product.

Partly completed machinery is an assembly that is not yet machinery because it cannot itself perform a specific application and is intended only to be incorporated into machinery, other partly completed machinery, or equipment. That classification changes the evidence package: the file should support relevant essential health and safety requirements, incorporation conditions, assembly instructions, and the EU declaration of incorporation.

The final machinery still needs its own conformity conclusion before it is put into service. The partly completed machinery record should therefore explain what has been assessed by the supplier and what remains for the integrator or final manufacturer.

Article 2 exclusions should be recorded as explicit reasons, not as informal assumptions. The regulation excludes, among other areas, identical spare safety components supplied by the original manufacturer, fairground or amusement-park equipment, certain nuclear-use machinery, weapons, and several transport categories, while machinery mounted on transport can still remain relevant.

A post-market physical or digital change can become a substantial modification when it was not foreseen or planned by the manufacturer, affects safety by creating a new hazard or increasing an existing risk, and requires either changes to guards or protective devices involving the safety control system or additional protective measures for stability or mechanical strength.

Annex I is the category checkpoint for higher-risk machinery and related products. Part A categories are tied to Article 25(2) procedures, while Part B categories are tied to Article 25(3) procedures and may allow internal production control only when the product is designed and constructed according to relevant harmonised standards or common specifications that cover all relevant essential requirements for that category.

The scope file should not merely say "Annex I applies". It should name the exact Part A or Part B item, explain the product features that match the item, and show whether harmonised standards or common specifications cover the relevant essential health and safety requirements.