Navigating CE Compliance – A Case Study

Navigating CE Compliance for entry into the EU can be daunting at times, because of the sheer number of regulations and Directives that may apply to your given product.  Without the help of a trusted testing partner (seriously, contact us when you have a new product in development), it may be difficult to determine what you are legally required to comply with. 

Any product that is going to be placed on the marketplace in Europe must comply with all Directives that are applicable to said product.  In this blog post we’re going to look at a sample product to determine what Directives apply and what needs to be done. 

Product in question – Flatscreen computer monitor

Power – 220VAC via supplied charger – no battery backup

In this scenario we are working with a piece of equipment that I bet most of us have lying around our home.  Now counter to US/Canadian certification where you find an applicable standard and test to it, European (CE) compliance requires us to first determine which Directives apply to the product and THEN find an appropriate Harmonized Standard under the Directive to test to.

Let’s first look at the electrical safety of this device.  Any device that connects to mains power, whether for operation or for charging is required to comply with the Low Voltage Directive (LVD) (2006/95/EC).  Some folks may point to the fact that this device operates under 60VDC and thus may qualify for an exemption under the LVD, however since it uses an off the shelf AC/DC brick power supply that is powered via mains, it must comply with the LVD.  The applicable standard under the LVD would be:

EN 62368-1 – Audio/video, information and communication technology equipment – Part 1: Safety requirements

Now we must address the Electromagnetic Compatibility (EMC) of the device.  The device must be tested to ensure it doesn’t affect other electronics and is itself not affected by Electromagnetic phenomena such as surges, interrupts, ESD, etc.   The standards for this category are below:

EN 55032 – Electromagnetic compatibility of multimedia equipment – Emission requirements

EN 55035 – Electromagnetic compatibility of multimedia equipment – Immunity requirements

Now all electrical devices must comply with RoHS (Restriction of Hazardous Substances) (2011/65/EC).  It is a CE marking Directive and you must comply in order to CE mark your device.  This usually is an analysis of your BoM to ensure compliance.  RoHS changes very infrequently, having only been modified once since 2002. 

Finally, the portion that gives a lot of manufacturers trouble in today’s marketplace is REACH.  Even though it is not a CE marking Directive, every product that ships into the EU must comply with the REACH Regulation.  Again, this is an analysis of your BoM, but to fulfill these obligations, manufacturers and importers need to prepare a registration dossier in a specific format (IUCLID) and submit it to the European Chemicals Agency (ECHA) via the REACH-IT portal.  This Regulation changes about every six months, and you must ensure that you meet the most recent version anytime you are shipping to the EU.  F2 Labs offer a subscription based service where we will ensure your product remains in compliance with REACH as it updates and changes.

F2 Labs is a turnkey solution when it comes to EU compliance.  We can assist with all required testing to claim compliance to the associated Directives and we will even draft a Technical File template that will include a draft Declaration of Conformity.

CONTACT F2 LABS FOR HELP, THIS IS WHAT WE DO.

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