Hi!
I've recently started working for a small startup company who manufacturers 3D-printers. My job is as compliance engineer, something I haven't specifically worked with before, I've only worked with EMC & LVD certification, not complete product certification according to regulation such as CE. I have two questions that I would want to ask here.
The company has one main product which is a 3D-printer with exchangeable printheads. They've CE certified this printer together with one type of printhead, which is the standard printhead for users to be using. The other 5 types of printheads are sold standalone as accessories to the 3D-printer, and are not CE certified in any way. When I've questioned why they are not CE certified the company has argued that the printheads are small accessories that do not fall under any of the CE directives. However, all printheads contain PCBs & electronics, and some of them are heated to very high temperatures, 250 degrees C being the highest. So my thinking is that these printheads either need to be CE certified together with the main 3D-printer product, and included in the 3D-printer DoC & Technical File, or that they need to be CE certified on their own. This is my first question, which of the three options here are correct?
1) Company is correct, printheads are small accessories and do not need to be CE certified.
2) Printheads should be CE certified together with main product, and included in main product DoC.
3) Printheads should be CE certified on their own, due to them being sold separately.
The second question I have is what directive these printheads would fall under. My first thought was that they would fall under the LVD directive, but since Article 1 in the LVD directive states that it only applies to products with a DC input voltage of 75-1500V that should not be the case, since the printheads have a DC input voltage of 24V. I then looked at the EMC directive since the printheads contain electronics, but that also seems to not apply due to that the printheads don't fulfill the definition of 'apparatus' in Article 3, section 1 (2). That would leave the printheads to maybe fall under the Machine Directive, since they could be considered "Interchangeable Equipment". Does this sound like a reasonable conclusion to you? I assume the printheads would also fall under the RoHS Directive.
I've recently started working for a small startup company who manufacturers 3D-printers. My job is as compliance engineer, something I haven't specifically worked with before, I've only worked with EMC & LVD certification, not complete product certification according to regulation such as CE. I have two questions that I would want to ask here.
The company has one main product which is a 3D-printer with exchangeable printheads. They've CE certified this printer together with one type of printhead, which is the standard printhead for users to be using. The other 5 types of printheads are sold standalone as accessories to the 3D-printer, and are not CE certified in any way. When I've questioned why they are not CE certified the company has argued that the printheads are small accessories that do not fall under any of the CE directives. However, all printheads contain PCBs & electronics, and some of them are heated to very high temperatures, 250 degrees C being the highest. So my thinking is that these printheads either need to be CE certified together with the main 3D-printer product, and included in the 3D-printer DoC & Technical File, or that they need to be CE certified on their own. This is my first question, which of the three options here are correct?
1) Company is correct, printheads are small accessories and do not need to be CE certified.
2) Printheads should be CE certified together with main product, and included in main product DoC.
3) Printheads should be CE certified on their own, due to them being sold separately.
The second question I have is what directive these printheads would fall under. My first thought was that they would fall under the LVD directive, but since Article 1 in the LVD directive states that it only applies to products with a DC input voltage of 75-1500V that should not be the case, since the printheads have a DC input voltage of 24V. I then looked at the EMC directive since the printheads contain electronics, but that also seems to not apply due to that the printheads don't fulfill the definition of 'apparatus' in Article 3, section 1 (2). That would leave the printheads to maybe fall under the Machine Directive, since they could be considered "Interchangeable Equipment". Does this sound like a reasonable conclusion to you? I assume the printheads would also fall under the RoHS Directive.
