CE Compliance for an OEM 2

[PaulKraemer]

Hi,

I work for a company that builds custom coating and web handling equipment, mostly for the pharmaceutical industry. The machines are mostly mechanical in nature, but every machine has motors, drives, a PLC, and typical electrical components like disconnects, contactors, relays, fuses, etc. After having sold a machine to Europe some time ago, we have standardized on using all CE marked components. We have never gone as far as having an entire machine CE marked. Aside from using all CE marked components, I imagine we also have to follow CE guidelines for wire colors. I know that for certain power components, the installation of filters is also required.

I was wondering if anyone here can give me some advice (or point me towards reading material) to help me understand what it will take for us to legitimately claim that a machine is CE compliant.

Thanks in advance,
Paul

 

[ScottyUK]

You need to get familiar with European legislation such as the Low Voltage Directive, the Machinery Directive, the EMC Directive, perhaps the ATEX Directives, and so on. They will lead you into the EN standards, or the national variants such as the BS EN standards. It's a minefield of liability!

You can't legally sell a machine into the European market unless it has an overall CE Mark unless you can sell it as a subcomponent of a larger machine.

 

[PaulKraemer]

Hi ScottyUK,

Thank you for your response. I will read up on the Low Voltage Directive, the Machinery Directive, the EMC Directive, ATEX Directives, and anything else this leads me into. Before I have had a chance to do this, my quick question is ... If I read these standards and feel like we have complied with all applicable directives in the design and construction of our machine, can I (as the equipment manufacturer) legally put a CE Mark on our machine? Or is there a governing body that would require me to get an authorized/licensed person to inspect it and then (hopefully) grant us a CE Mark?

This machine would be going to Greece, and it is a standalone unit, so I can't think of a way I could argue that it is part of a larger machine.

I appreciate your help.

Best regards,
Paul

 

[Mobius44]

Paul,

The CE Mark is self-certified, but I suggest you use a third party to guide you through the process the first time.

The big names like UL, CSA, or TUV can help you, but if cost matters then I recommend using a smaller consultant.

The company I work for recently used Technology International to help us CE mark some equipment, and they helped us create a CE file which we can easily update with additional products.

https://www.techintl.com/

Please note I'm in no way affiliated with them, and I'm sure there are other options too.

Best of luck,
Sean

 

[PaulKraemer]

Thank you Modbius44 - Several years ago, I had attempted to read through the different directives with the hope of determining which would apply to equipment like ours and which would not. I found it very difficult to understand. I agree that getting assistance (at least for the first time), is probably a good idea. I sent an email to tchintl. Hopefully they server New Jersey.

Thanks and best regards,
Paul

 

[zappedagain]

https://ec.europa.eu/growth/single-market/ce-marking/manufacturers_en

is a good place to get started on the CE Mark. You need to figure out what category your equipment fits into. if it doesn't fit any existing category, you can still get a mark but it gets much more complicated and expensive.

We make measurement equipment, so it falls under:

2011/65/EU – RoHS (Reduction of Hazardous Substances)
and
2014/35/EU – Low Voltage Directive (LVD) that calls out the IEC 61010-1 standard for my equipment, and IEC 60825-1 because we use a laser.
and
2014/30/EU – Electromagnetic compatibility (EMC) that calls out EN 61326-1, EN 61000-4-2, EN61000-4-3, EN61000-4-4, EN61000-4-5, EN61000-4-6, and EN61000-4-11
and
2014/53/EU – Radio Equipment Directive (RED) that calls out EN 305 550-2.

You'll have a different list, but it may end up being about this long.

Z