4S prepares a written risk assessment for your machine, as required by the Machinery Directive 2006/42/EC – and, from 20 January 2027, by the Machinery Regulation (EU) 2023/1230 – for every manufacturer of a machine. It forms the basis for CE marking and is a mandatory part of the technical documentation.
According to Annex I of the Directive:
“The manufacturer of machinery or his authorised representative must ensure that a risk assessment is carried out in order to determine the health and safety requirements which apply to the machinery. The machinery must then be designed and constructed taking into account the results of the risk assessment.”
Who is affected
Becoming a manufacturer is not limited to building a new machine. Anyone who modifies or extends an existing machine can thereby become a manufacturer themselves – with the same obligation to carry out a risk assessment. The same requirement applies to manufacturers of partly completed machinery.
What the risk assessment covers
The risk assessment is based on the harmonised standard EN ISO 12100 (Safety of machinery – General principles for design – Risk assessment and risk reduction), which is harmonised under the Machinery Directive. Complying with the standard also satisfies the corresponding requirements of the Directive. The hazards of the machine are systematically identified across its entire life cycle, the resulting risk is evaluated, and protective measures are derived in the order of priority set out in the standard: first by inherently safe design, then by technical measures, and finally through information for use.
Process
- You send me the available documentation on the machine – design data, drawings, circuit diagrams, and, for modifications, the existing instructions for use and any earlier risk assessment.
- The hazards are identified from the documentation and, once the machine is assembled, on site.
- You receive the written risk assessment according to EN ISO 12100, listing all identified hazards, their evaluation, and the derived protective measures.
- A joint follow-up discussion to agree on the safety measures that are practically implementable for your project.
What you end up with
A complete, traceably documented risk assessment that you use as part of your technical documentation – the basis for the instructions for use, the declaration of conformity, and for a further safety concept.
In addition
Whether a protective device provides sufficient distance from the hazard zone can already be worked out and documented in advance with the free online calculators according to EN ISO 13855 and EN ISO 13857.
Not sure whether your modification makes you a manufacturer and therefore requires a risk assessment? CONTACT 4S – I will help you clarify the requirements under the applicable regulation.
Are you delivering machinery into German-speaking markets (Germany, Austria, Switzerland)? 4S can also act as your German-speaking point of contact on site and support the entire project from a safety-engineering perspective. Technical documents are prepared directly in German or English; a Spanish or Swedish version is translated on request.