Whoever places a machine on the market is responsible for it being safe and CE marked. That does not only apply to machine builders: if you substantially modify an existing machine, combine several machines into one line or import a machine from outside the EU, you become the manufacturer in the eyes of the law. What that documentation must contain is set out point by point in Verkio's guide to technical documentation for machine builders.
The most common mistake
Assuming the CE marking follows the machine after a rebuild. A substantial modification means a new machine in practice – with a new risk assessment, new documentation and a new declaration of conformity.
The Machinery Regulation applies from 20 January 2027
Machinery Directive 2006/42/EC is replaced by the Machinery Regulation (EU) 2023/1230. The regulation applies directly in every member state, sets clearer requirements on digital documentation and takes particular aim at machines with software, connectivity and self-learning behaviour. Documentation written today needs to hold after 2027 as well.
This is what you need to know
- The difference between the Machinery Directive and the new Machinery Regulation, and the timeline up to 2027
- When a rebuild counts as substantial and makes you the manufacturer
- Assemblies of machinery: when several machines become one, and what that means for the marking
- Risk assessment to SS-EN ISO 12100 and the choice of protective measures
- Technical documentation, instructions for use and the EU declaration of conformity
Common questions about CE marking
These are the questions that come up most often when a machine is rebuilt or bought in.
- We are buying a used machine from inside the EU. Do we have to do anything?
- If the machine is already CE marked and unchanged, the marking follows it. If you rebuild it, or buy it from outside the EU, the manufacturer's responsibility becomes yours.
- What counts as a substantial modification?
- A change that creates a new risk or increases an existing one, for example higher speed, a new function or a guard removed. That calls for a new risk assessment and, in practice, a new CE marking.
- Do we need a notified body?
- Only for machines on the list of high-risk machinery. For most machines the manufacturer makes the assessment itself and signs the declaration of conformity.
Not sure what applies to your machine?
Send us a short description and we will tell you which course fits and what you need to document.
See all courses