Lee.k
Mechanical
- Dec 6, 2023
- 7
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?
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?