Frequently asked questions on law and regulations

As an EU regulation it applies directly in all member states, without national transposition. New in substance are digital instructions for use, requirements for cybersecurity and self-evolving functions, and a new procedure for high-risk machinery. The basic system of risk assessment, technical documentation and declaration of conformity stays as it is.

From 20 January 2027. Machinery placed on the EU market for the first time from that day has to meet the Machinery Regulation. Machinery placed on the market earlier remains assessed under the Machinery Directive.

What counts is the moment of placing on the market, not the start of construction or the date of order. Up to and including 19 January 2027 Directive 2006/42/EC applies, from 20 January 2027 the Machinery Regulation. For projects running across the deadline the target date should be clarified early and fixed in the contract.

Machinery and partly completed machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, and removable mechanical transmission devices. Newly covered explicitly are related software with a safety function and systems with self-evolving behaviour. Exceptions exist for certain vehicles, military equipment and products covered by other legal acts.

Existing machinery does not have to be converted to the Machinery Regulation afterwards. It keeps its existing CE marking as long as it continues to be operated unchanged. For operation, occupational safety law continues to apply, in Germany above all the Ordinance on Industrial Safety and Health.

No, not because of the deadline alone. A new assessment only becomes necessary if the machine is substantially modified or placed on the market again, for instance when imported into the EU from a third country. Continued operation on its own triggers no obligation.

A modification is substantial if it creates a new hazard or increases an existing risk and the safeguards in place are no longer sufficient for it. What decides is not the scale of the conversion but its effect on safety. The assessment path is described in the interpretation paper on substantial modification.

When the modification is substantial and the increased risk cannot be brought back to an acceptable level by simple safeguards. A new machine then comes into being in practice: risk assessment, technical documentation, declaration of conformity and CE marking have to be produced again. Whoever carries out or commissions the conversion becomes responsible.

Machinery can perform its intended function on its own and receives CE marking, instructions for use and a declaration of conformity. Partly completed machinery is clearly intended to be incorporated into other machinery; it receives no CE marking but assembly instructions and a declaration of incorporation. The most common misunderstanding: partly completed machinery is not the same as unfinished machinery.

As soon as it is connected with further components so that the whole performs a function of its own. A new machine or an assembly of machinery then comes into being, and whoever puts it together becomes the manufacturer with all the associated duties. The declarations of incorporation of the individual parts move into that party's technical file.

The system stays the same: assembly instructions and declaration of incorporation instead of instructions for use and declaration of conformity. What is new is that the assembly instructions may also be provided digitally and that the requirements for the described interface conditions are worded more precisely. Anyone supplying partly completed machinery should document the safety-related assumptions for incorporation more clearly than before.

To be supplied with the machine: instructions for use and the EU declaration of conformity. To be kept internally: the technical documentation with risk assessment, drawings, calculations, test records and the list of standards. For partly completed machinery, assembly instructions and a declaration of incorporation take the place of the first two. Read in full

Safety-related control systems have to be protected against unintentional and intentional corruption. Required are protection against unauthorised intervention in software and data, traceability of interventions and securing of remote access. In practice this affects every machine with a network connection or remote maintenance.

Machinery with self-evolving behaviour has to be designed so that the safety functions remain effective after learning processes as well. The behaviour has to be logged, and the limits of permitted learning belong in the risk assessment and the instructions for use. Certain systems of this kind also fall under the stricter procedure for high-risk machinery.

As a basis EN ISO 12100 for risk assessment, EN ISO 13849-1 for safety-related parts of control systems, EN 60204-1 for electrical equipment and EN ISO 20607 for instructions for use. On top comes the type-C standard for the machine type in question; it takes precedence over the general standards. Where no type-C standard exists, safety is derived from the type-A and type-B standards.