EU Machinery Regulation (EU) 2023/1230: 2027 transition approaching for CE marking

Machinery Regulation (EU) 2023/1230 becomes mandatory on 20 January 2027. The key feature of this date is that no transition period follows it: as the regulation begins full application, the Machinery Directive 2006/42/EC ceases to apply on that same day.

The "you may continue under the old framework for a while" flexibility seen in many other EU regulations is absent here. If the conformity file is not ready under the new regulation on 20 January 2027, the product cannot be placed on the market that day.

A directive turning into a regulation also means the national-transposition stage disappears: the rules apply directly and with identical text in member states.

Annex I of the regulation lists machinery requiring special conformity assessment with notified-body involvement. The list is split into two parts, and this split directly determines the route to follow.

For categories in Part A, notified-body involvement is mandatory in every case. In Part B, the route is more flexible: it depends on the status of harmonised standards.

Available procedures include EU type-examination, full quality assurance and unit verification. Which one to choose is not only a technical preference; it is a decision that must be evaluated together with production volume and product variety.

The most discussed innovation of the regulation is that AI systems performing a safety function make the machine high-risk under Annex I. This definition removes the self-declaration option and makes third-party notified-body assessment mandatory.

The result is a situation where a design decision changes the conformity route: handing a safety function to a learning algorithm puts the file on an entirely different path. The decision should therefore be made together with conformity planning, not in an engineering meeting alone.

Cybersecurity is also among the regulation's topics: protecting the machine's safety functions against deliberate interference now stands as an explicit requirement.

Notified-body capacity is a limited resource, and queues lengthen as the date approaches. Leaving the application for an Annex I product to the final months directly creates the risk of not being ready by the date.

There is work even for products outside Annex I: the risk assessment, technical file and instructions for use need reviewing against the new regulation's structure. This is an update written onto the existing file, not a task from scratch, but it does not finish in a single sitting.

The core reason behind renewing machinery legislation is technological: machines are no longer just structures carrying mechanical hazards but have become software-controlled, learning, networked systems.

The new regime therefore explicitly brings software-originated risks, AI-containing safety functions and cybersecurity into scope. If a safety function is implemented in software, the software's reliability is now part of the machine's safety.

The second structural change is the renewal of the high-risk machinery list and the clarification of the notified body's role for machines on it. Some categories previously open to manufacturer self-declaration can now fall under the notified body's scope.

The new regime allows the instructions for use and declaration of conformity to be provided digitally; but this is not an exemption: providing a printed copy on user request and keeping safety information accessible are preserved.

The practical condition for digital provision is permanence of access: the link must work throughout the product's life and the content must be kept under version control. A broken link is equivalent to a missing manual.

The language requirement does not change: information is provided in the official language of the member state where the product will be sold.

Transition does not mean a wholesale reassessment of existing machines: machines placed on the market under the old regime up to a certain date remain under their own regime.

The effect is seen in new designs and in machines undergoing a substantial modification. The concept of "substantial modification" is critical in this arrangement: when a machine's function, safety system or intended use changes, the party making the change may move into the position of a new manufacturer.

The controllable preparation items are: expanding the risk assessment with software and cybersecurity dimensions, documenting the reliability level of safety functions, and screening the product portfolio against the high-risk list.