CE Mark Requirements for Components - Solenoid Actuator Type Devices

Hi CE Gurus!

I have researched heavily into CE Marking for our product and have received mixed responses from different test facilities and have become even more confused by the CE Marking requirements.

We sell solenoid actuator type devices all over the world including Europe. These can go to end users, such as laboratories, or to manufacturers who incorporate it into their system before resale.

These actuators can be in incorporated into medical devices, bioskids, industrial rigs, or beer machines.

The actuators use a mechanical spring to extend the rod and a solenoid to retract. They operate at 32 VDC max and can have hall effect sensors added to the actuator to provide feedback on position. Sensors operate around 10-32 VDC.

I have been told since it is "inherently benign" and it does not fall under the EMC directive. Also, if it doesn't fall under any safety directive then the RoHS directive would apply and it can be CE Marked under only that directive. I have also been told by another source that since it is a component it would not require CE Mark.

From reading the Low Voltage Directive, as it is below 75 VDC I have concluded it does not fall under that directive.

The more I read the more confusing it becomes. Any help would be appreciated!

Thank you!

QCOcra said:

since it is a component it would not require CE Mark.

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This is generally not true.

If you place it on the EU market and any of the 20-something CE marking directives/regulations apply to it, and they don't explicitly exempt it under some clause, it does need CE marking. In general it doesn't matter if you sell it to EU end users or to EU manufacturers to use as components.

Other than that it's a matter of careful, detailed examination of the devices against the applicability statements in each and every one of those 20-something directives/regulations. This would require full access to the devices design and a significant amount of time.

Cheers,
Ronen.

Hi Ronen. Thanks for the response. It seems like professional consultation may be required which would most likely be thousand of dollars.

It still piques my interest on whether a magnetic coil which is the basis of a solenoid-actuator can be considered "inherently benign" or not. It is producing a magnetic field when powered on. There is not much guidance on what is considered "inherently benign" and what is not in the Directive.

QCOcra

QCOcra said:

which would most likely be thousand of dollars.

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Not necessarily.

QCOcra said:

It still piques my interest on whether a magnetic coil which is the basis of a solenoid-actuator can be considered "inherently benign" or not. It is producing a magnetic field when powered on. There is not much guidance on what is considered "inherently benign" and what is not in the Directive.

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Directives don't usually provide guidance, however relevant guidance can sometimes be tracked elsewhere. That would be part of the applicability analysis which I mentioned, and that's one of the reasons that this is not a 5-minute job.