CE Marking

[Lee.k]

I need to understand how the CE marking process works when a machine is being supplied to us (from one site) & then integrated with our machinery on another site. I shall now explain in more detail:

We, (a manufacturer), have injection moulding machines that produce individual parts for the medical industry. We are based in Slovakia.

We have appointed a contractor - a manufacturer based in Denmark - to modify an existing assembly machine - that was taken from a competitor based in Denmark – that will undergo some modifications to improve certain functional characteristics.

Once the modifications are complete, the assembly machine will be delivered to us & be integrated with two of our existing injection moulding machines - that are already CE marked – to complete the “final production system”. Note – the assembly machine won’t be able to fulfil its function without first being integrated with our machines.

My questions are as follows:

• Should the contractor deliver the assembly machine to us CE marked?

• Whether the above answer is a “yes” or “no”, is it also necessary to get the “final production system” CE marked, i.e the assembly machine integrated with our injection moulding machines?

• To get CE marking, what documentation should:
- the contractor provide &
- what documentation should we provide?

• Although in most cases CE marking is something that the manufacturer does themself, who exactly (what position / authority) provides this & how does the application process work?

 

[BrianPetersen]

As I understand it (and due to the complexity of the process, I am quite open to be shown wrong) ...

The CE marking under the machinery directive pertains to equipment safety, so "won't be able to fulfill its function" has to be re-interpreted in terms of machinery safety (it isn't merely that one machine can't work because the other one isn't feeding it parts):
- Is the other equipment's manufacturer complete in terms of its compliance to machinery safety standards (for example, it has its own perimeter guarding and its own interlocked doors which allow access to that machine alone), or is it incomplete and reliant for purposes of safety to be integrated into your machine (for example, the perimeter fencing is open on one side where it connects to your machine and the door-interlock safety functions are tied together between their machine and yours)?
- What is the connection between the two machines (theirs and yours) in terms of machine safety? If one machine has a protective-stop due to a safety interruption, is it necessary to stop the other machine for safety reasons (because someone can access the interior of the other machine, or because some other hazard to personnel is introduced because the one machine stops and the other doesn't)?
- And, most importantly, whose risk assessment addresses this?

If there is an element of this system that is being supplied incomplete, because it relies upon the completion of the integration with equipment supplied by others in order to complete the safeguarding and close-out the risk assessment, then that incomplete machine should not be CE marked, but should be supplied with a declaration of conformity as partially completed equipment, and with a clear set of instructions and requirements for how the integration by others is to be completed in order to be compliant with relevant safety standards. The integrator has to supply the risk assessment, CE marking, declaration of conformity, and technical file sufficient to show that what was left open due to the incomplete machinery has been completed.

If the two subsystems are complete in terms of their safeguarding then they can each have the CE marking, declaration of conformity, and technical file including risk assessment which each pertain to their own equipment, and there needs to be another risk assessment, CE marking, and technical file including risk assessment for the integration between the two.

 

[XL83NL]

As ET (eng-tips) is free to access forum, with free advice from all sorts of members, I think the points given by Brian are the best tips you'll gonna get without having to pay for it. The only way to get more advice is to do some homework yourself and examine the EU Blue Guide or Guide to application of the Machinery Directive 2006/42/EC. By learning and understanding whats in there, you'll gain more knowledge.

Huub
- You never get what you expect, you only get what you inspect.