A major change awaits machinery designers: the familiar Machinery Directive will be replaced by the new Machinery Regulation on 20 January 2027. What does this mean in practice, and how should you prepare?
The EU’s Machinery Regulation will supersede the long-standing Machinery Directive. Strictly speaking, the Regulation is already in force and is already being applied in part, for example with regard to the activities of authorities. For machinery manufacturers, the essential date is 20 January 2027 – from then onwards, all new machines must comply with the Regulation, and until that date, with the Directive.
There is no overlap in validity, which means that the transition period is effectively already under way.
Why is the Machinery Directive changing into a regulation?
A directive and a regulation differ significantly. A directive defines the outcome that Member States must achieve, but leaves the means to national legislation. A regulation, by contrast, applies directly and uniformly in all EU countries – immediately and without room for interpretation.
From 2027 onwards, legislation governing machinery safety will, for the first time, be harmonised across the entire EU. At the same time, the updating of requirements will become quicker and simpler, as Member States will no longer need to amend their national laws each time changes are made.
What is new in the Machinery Regulation?
Although many aspects remain the same – such as safe design, conformity assessment, adequate documentation and CE marking – the Regulation also introduces several significant changes:
Electronic technical documentation:
It is now permitted, but the manufacturer must still supply free paper copies upon request. Instructions integrated into the user interface must also remain accessible even if the machine is damaged.
New health and safety requirements:
For example, machinery requiring a seatbelt must not operate unless the belt is in use. In addition, physical and psychological strain must be eliminated or minimised.
The growing role of software:
Software that affects the safety of a machine must be included in the technical documentation, including source code and update information.
Risk documentation and the Declaration of Conformity
Unlike the Machinery Directive, the Regulation requires every protective measure to be documented so that the corresponding health or safety requirement is clearly identified. Risks arising from self-evolving behaviour or logic of the machine must also be considered. This may create challenges for some manufacturers.
The Declaration of Conformity will also see changes. In future, it must include a statement that the declaration is made under the manufacturer’s sole responsibility, and it must specify which parts of standards have been applied when they are used only partially. In practice, this demands more precise definition of requirements before design begins, as well as robust documentation throughout the design process. This is not mere bureaucracy: thorough documentation supports later product development and helps ensure safety throughout the machine’s lifecycle.
When do you need external assistance?
Under the Machinery Regulation, the list of machines requiring external involvement in the conformity assessment process is divided into two categories. The EU updates this list every five years, based on information provided by Member States concerning accidents, incidents, near misses, health impacts and identified safety deficiencies.
The aim is for updates to be based on real risks rather than fears or overly cautious restrictions.
The Machinery Regulation brings new documentation requirements, and it is worth preparing for them now. Many designers will need to familiarise themselves more thoroughly with documentation practices, but the fundamental principles of design remain largely unchanged. Now is the right time to ensure that your organisation’s processes and documentation are ready for the transition.
