Frequently asked questions.
Some things are good to know.
Is CE-marking obligated?
When your product is within the scope of European legislation: Yes.
For machinery the primary regulation is 2023/1230. Full title: Regulation (EU)2023/1230 of the European Parliament and of the Council of 14 June 2023 on machinery and repealing Directive 2006/42/EC of the European Parliament and of the Council and Council Directive 73/361/EEC
We have a flowchart to determine to what European legislation a product must comply with. See the CE-marking: Step 1 page.
Why is CE-marking mandatory?
Some European product legislation goals are, and therefore also CE-marking is:
- To create a level playing field for all economic operator on the European market.
- To guarantee a high level of protection of public interests such as the health and safety of persons, animals, property and environment.
This means it is not only a safety thing, but also a method to promote an EU goal: Free movement of goods within the Union.
For whom is CE-marking obligated?
In short: The manufacturer of the machinery.
However, there are several other roles of legal or natural persons that have responsibilities. We name them here, but do not go into the deep. Chapter II of2023/1230 offers full details.
- Manufacturer.
- Authorised representative.
- Importer.
- Distributor.
Also, the of legal or natural person responsible for:
- A substantial modification must do CE-marking. On the CE-marking: Page 0 there is a flowchart which can help.
- Assembling machinery may need to do CE-marking. On the CE-marking: Page 0 more information can be found.
Am I allowed to do CE-marking myself?
In most machinery cases: Yes.
However, for some category of machinery a notified body might need to be involved. You can find these categories in Annex I of regulation 2023/1230.
On the CE-marking: Step 3 page, a flowchart helps with selecting the proper compliance procedure.
Remember that there are other roles than the (original) manufacturer.
What is the easiest way to do CE-marking as a manufacturer?
Just do it yourself! Get help from a consultant, use an appropriate format of the CE-assistant tool, or start from scratch. Just remember that the manufacturer, in the end, is responsible for CE-marking.
Why do I have to do a risk assessment?
As a manufacturer you want your machinery to be as safe as possible. This means thinking about risks involved. Also it is compulsory: 2023/1230, and other product legislation, mentions that for each product a risk assessment should be carried out.
Is there a tool for risk assessments?
Yes there is and the CE-assistant tool includes one. It is a risk-graph type assessment tool, based on ISO 12100 and harmonised standards depending on the chosen format.
How do I prepare a Declaration of Conformity?
We have a checklist how to prepare the DoC. It is available on the Others: Checklists page.
When you use the CE-assistant tool you do not prepare the DoC. It is generated for you.
What should be part of the technical documentation?
We have a checklist what should be included in the technical documentation according to 2023/1230. It is available on the Others: Checklists page. Remember that certain harmonised standard have some extra technical documentation demands. These are included in the chosen format of the CE-assistant tool.
Do I, as the manufacturer of machinery, have to draw up a user manual?
Absolutely! The user manual is an integral part of your machinery. Writing user manuals is often seen as the least popular thing to do while engineering and manufacturing machinery. But it is an obligation. And be honest: How should your customer be able to properly work with your complex machinery without it? Also, the user manual is part of the technical documentation: It just needs to be available. Simple as that. CE-assistant can offer help with drawing up user manuals.
What should be included in the user manual?
We offer a checklist about this. It is based on 2023/1230. It is available on the Others: Checklists page. Remember that certain harmonised standard have some extra user manual demands. These are included in the chosen format of the CE-assistant tool.
What should be mentioned on the nameplate?
There is a checklist for this. It is based on 2023/1230. It is available on the Others: Checklists page. Remember that certain harmonised standard have some extra nameplate and other markings demands. These are included in the chosen format of the CE-assistant tool.
Can I be, as the manufacturer of machinery, hold liable for any issues with my machinery? For instance, any damages and/or personal harm resulting from the use of my machinery?
Certainly. 2023/1230 even includes ‘reasonably foreseeable misuse’ besides ‘normal use’ of the machinery. This ‘reasonably foreseeable misuse’ is part of the obligated risk assessment and a safety integration principle .
‘Reasonably foreseeable misuse’ means the use of machinery or a related product in a way not intended in the instructions for use, but which may result from readily predictable human behaviour.
For a manufacturer it is key to demonstrate that all steps of the CE-marking process have been followed up.